The remarkable increase in the number of antibody therapeutics in late-stage clinical studies that occurred between 2010 and 2021 has been documented in the ‘Antibodies to watch‘ article series, which describes monoclonal antibodies in late-stage clinical studies (i.e., pivotal Phase 2, Phase 2/3 or Phase 3). All articles in the series were published in mAbs, and they are all freely available.
The table below is derived from data included in the latest article in the series, Antibodies to Watch in 2022, published in January 2022. The Antibody Society will update the data every quarter during 2022. Last table update: May 1, 2022.
Data for antibody therapeutic products that have advanced to regulatory review or approval in any country have been excluded from this table, but they are included in a searchable table that can be found here.
Biosimilar antibodies have been excluded from both tables.
Format and Fc modification data were compiled by Drs. Alicia Chenoweth and Silvia Crescioli, King’s College London, who also built the data table below.
Please cite our data as follows: The Antibody Society. Antibody therapeutics in late-stage clinical studies. (date accessed); www.antibodysociety.org/antibodies-in-late-stage-clinical-studies/
| INN | Drug Code(s) | Target | Format | Specificity | Backbone | Light Chain | Conjugations/Fusion | Mutations/Modifications | Phase of Clinical Development | Late-stage Clinical Study Indications | Therapeutic Area | Company | Licensee/Partner | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 177Lu-DOTA-rosopatamab | TLX591, ATL-101, Lu-177-huJ591 | PSMA | Humanized mAb | Monospecific | IgG1 | kappa | Conjugated to Lu-177 | Phase 3 pending | Prostate cancer (NCT04876651 (not yet recruiting)) | Cancer | Telix Pharmaceuticals | |||
| Abelacimab | MAA868 | Factor XI | Human mAb | Monospecific | IgG1 | lambda | Phase 3 | Venous thromboembolism (NCT05171075, NCT05171049) | Cardiovascular/hemostasis | Novartis | Anthos Therapeutics, MorphoSys | |||
| Adebrelimab | SHR-1316, HTI-1088 | PD-L1 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization), F234A, L235A (abrogate effector function) | Phase 3 | Non-small cell lung cancer (NCT04316364); Small cell lung cancer (NCT04691063, NCT03711305 (not yet recruiting)) | Cancer | Jiangsu Hengrui Medicine Co. | Atridia Pty Ltd. | ||
| Anbenitamab | KN026 | HER2, HER2 (biparatopic) | Humanized mAb | Bispecific | IgG1; Hetero H | kappa (common light chain) | Hetero HH, HL-pairing: cL: S354C-T366W-K409A x Y349C-T366S-L368A-F405K-Y407V (bispecific assembly) | Phase 2 (pivotal); Phase 2/3 pending | HER2+ Solid tumors (NCT04521179); HER2+ Breast cancer (NCT04165993); Gastric/Gastroesophageal junction cancer (NCT03925974, KN026-CSP-001) | Cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Sanofi | ||
| Anselamimab | CAEL-101, Ch mAb 11-1F4 | Amyloid fibril | Chimeric mAb | Monospecific | IgG1 | kappa | Phase 3 | Light chain (AL) amyloidosis (NCT04512235, NCT04504825) | Immune-mediated disorders | Caelum Biosciences | AstraZeneca | |||
| Apitegromab | SRK-015 | Myostatin | Human mAb | Monospecific | IgG4 | lambda | Phase 3 | Spinal muscular atrophy (NCT05156320) | Muscular diseases | Scholar Rock | ||||
| Batoclimab | IMVT-1401, RVT-1401, HL161BKN, HBM9161(HL161BKN), HL161 | FcRn | Human mAb | Monospecific | IgG1 | lambda | L234A, L235A (impair Fc effector functions) | Phase 3 | Primary immune thrombocytopenic purpura (NCT04428255); Thyroid opthalmopathy (NCT05015127); Myasthenia gravis (NCT05039190) | Immune-mediated disorders | Hanall Biopharma, a subsidiary of Daewoong Pharmaceutical Co., Ltd | Harbour BioMed, Roivant Sciences / Immunovant Inc. | ||
| Bemarituzumab | FPA144 | FGFR2b | Humanized mAb | Monospecific | IgG1 | kappa | Afucosylated | Phase 3 | Gastric cancer/gastroesophageal junction adenocarcinoma (NCT05052801) | Cancer | Amgen | Zai Lab | ||
| Bentracimab | PB2452 (formerly MEDI2452) | Ticagrelor | Human Fab | Monospecific | Fab (IgG1 CH1) | lambda | Phase 3 | Reversal of the antiplatelet effects of ticagrelor in patients with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure (NCT04286438) | Cardiovascular / hemostasis | AstraZeneca | PhaseBio Pharmaceuticals, Inc., Alfasigma | |||
| Bintrafusp alfa | M7824, MSB0011359C | PD-L1, TGFβ | Human mAb | Bispecific | IgG1 | lambda | IgG1 fused with TGFbeta binding domain | Phase 2/3 and Phase 3 | Biliary tract cancer (NCT04066491); Non-small cell lung cancer (NCT03631706); Follow-up study to collect long-term data on participants from multiple Bintrafusp Alfa clinical studies (NCT05061823 (not yet recruiting)) | Cancer | EMD Serono/Merck KGaA | |||
| Birtamimab | NEOD001 | Amyloid | Humanized mAb | Monospecific | IgG1 | kappa | Phase 3 | Light chain (AL) amyloidosis (NCT04973137) | Immune-mediated disorders | Onclave Therapeutics Limited, subsidiary of Prothena | ||||
| Brazikumab | AMG139, MEDI2070 | IL-23 | Human mAb | Monospecific | IgG2 | lambda | Phase 2/3 and Phase 3 | Crohn's disease (NCT03759288, NCT03961815) | Immune-mediated disorders | Amgen | AstraZeneca; AbbVie/Allergan | |||
| Camidanlumab tesirine | ADCT-301 | CD25 | Human mAb | Monospecific | IgG1 | kappa | Conjugated to pyrrolobenzodiazepine dimer SG3249 | Phase 2 (pivotal) | Hodgkin lymphoma (NCT04052997) | Cancer | ADC Therapeutics Sarl | AbbVie | ||
| Cendakimab | CC-93538, RPC4046; ABT-308, 13C5.5 | IL-13 | Humanized mAb | Monospecific | IgG1 | kappa | L234A, L235A (impair Fc effector functions) | Phase 3 | Eosinophilic esophagitis (NCT04753697, NCT04991935) | Immune-mediated disorders | AbbVie | Bristol-Myers Squibb | ||
| Cetrelimab | JNJ-63723283 | PD-1 | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 2/3 and Phase 3 | Multiple myeloma (NCT03357952); Urinary bladder neoplasms (NCT04658862) | Cancer | Janssen Research & Development, LLC | XOMA Corporation | ||
| Clazakizumab | ALD518; BMS-945429 | IL-6 | Humanized mAb | Monospecific | IgG1 | kappa | N297A (Fc-aglycosylated) | Phase 3 | Antibody-mediated rejection in kidney transplant recipients (NCT03744910) | Immune-mediated disorders | H. Lundbeck | Vitaeris Bio | ||
| Cobolimab | GSK4069889, TSR-022 | TIM-3 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 2/3 | Non-small cell lung cancer (NCT04655976) | Cancer | GlaxoSmithKline | |||
| Concizumab | NNC172-2021, NN7415, mAb2021 | Tissue factor pathway inhibitor | Humanized mAb | Monospecific | IgG4 | kappa | Phase 3 | Hemophilia A or B with inhibitors (NCT04083781); Hemophilia A or B without inhibitors (NCT04082429) | Cardiovascular / hemostasis | Novo Nordisk | ||||
| Coprelotamab | GB221 | HER2 | Humanized mAb | Monospecific | IgG1 | kappa | Phase 3 | HER2+ Breast cancer (NCT04164615) | Cancer | Genor Biopharma Co., Ltd. | ||||
| Cosibelimab | CK-301 | PD-L1 | Human mAb | Monospecific | IgG1 | lambda | Phase 1 (registrational) and Phase 3 | Squamous cell carcinoma (NCT03212404) ; Non-small cell lung cancer (NCT04786964) | Cancer | Checkpoint Therapeutics, Inc. | ||||
| Crovalimab | SKY59, RG6107, RO7112689 | Complement C5 | Humanized mAb | Monospecific | IgG1 | kappa | L235R, G236R, S239K, A327G, A330S, P331S (impair Fc binding/effector functions), M428L, N434A, Q438R, S440E (increase FcnR binding without increasing RF binding) | Phase 3 | Atypical hemolytic uremic syndrome (NCT04861259, NCT04958265); Paroxysmal nocturnal hemoglobinuria (NCT04434092, NCT04432584, NCT04654468) | Cardiovascular / hemostasis | Chugai | Hoffmann-La Roche | ||
| Dafsolimab setaritox + grisnilimab setaritox | T-Guard; SPV-T3a + WT1 | CD3 + CD7 | Mixture of two mAb murine | Two monospecific mAbs | IgG2b, IgG2a | kappa; lambda | Conjugated to ricin A | Phase 3 | Steroid-refractory acute graft vs. host disease (NCT04934670) | Immune-mediated disorders | Xenikos | |||
| Dapirolizumab pegol | CDP-7657 | CD40L | Humanized Fab | Monospecific | IgG1 | kappa | PEGylated | Phase 3 | Systemic lupus erythematosus (NCT04976322, NCT04294667) | Immune-mediated disorders | UCB | Biogen | ||
| Datopotamab deruxtecan | DS-1062 | TROP-2 | Humanized mAb | Monospecific | IgG1 | kappa | Conjugated to deruxtecan DX-8951 (Topoisomerase I inhibitor) | Phase 3 | Non-small cell lung cancer without actionable genomic alterations (NCT04656652); Breast cancer (NCT05104866) | Cancer | Daiichi-Sankyo | |||
| Depemokimab | GSK3511294 | IL-5 | Humanized mAb | Monospecific | IgG1 | kappa | M252Y, S254T, T256E (half-life extension) | Phase 3 | Severe uncontrolled asthma with an eosinophilic phenotype (NCT04719832, NCT04718103, NCT04718389) | Immune-mediated disorders | GlaxoSmithKline | |||
| Domvanalimab | AB154 | TIGIT | Humanized mAb | Monospecific | IgG1 | kappa | L234A, L235A (impair Fc effector functions) | Phase 3 | Non-small cell lung cancer (NCT04736173) | Cancer | Arcus Biosciences | Gilead Sciences | ||
| Ebdarokimab | AK101 | IL-12/23p40 | Humanized mAb | Monospecific | IgG1 | kappa | Phase 3 | Plaque psoriasis (NCT05120297) | Immune-mediated disorders | Akesobio Australia Pty Ltd | ||||
| Elranatamab | PF-06863135 | BCMA, CD3 | Humanized mAb | Bispecific | IgG2a | Strop Fab-arm exchange method ((WO2016/166629) CD3 antibody: IgG1RRR: 221R, 228R, K409R or IgG2deltaA-RRRR: 223R, 225R, 228R, K409R; Target antibody: IgG1EEE: 221E, 228E, L368E or IgG2deltaA-EEEE: 223E, 225E, 228E, L368E, Exchange with 1-2 mM GSH). | Phase 3 | Multiple myeloma (NCT05020236) | Cancer | Pfizer | ||||
| Epcoritamab | GEN3013, DuoBody-CD-3x-CD20 | CD20, CD3 | Humanized mAb | Bispecific | IgG1; Hetero H | lambda/kappa | Hetero HH, HL exchanged: L234F x K409R (bispecific assembly) both chains L234F, L235E, D265A (Fc silencing) | Phase 3 | Diffuse large B-cell lymphoma (NCT04628494) | Cancer | Genmab | AbbVie | ||
| Erfonrilimab | KN046 | PD-L1, CTLA4 | Humanized, chimeric mAb | Bispecific | IgG1; Hetero H; VH-VH-h-CH2-CH3 dimer | n/a | Hetero HH, HL-pairing: cL: S354C-T366W-K409A x Y349C-T366S-L368A-F405K-Y407V (bispecific assembly) | Phase 3 | Non-small-cell lung cancer (NCT04474119, NCT05001724 (not yet recruting)) | Cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | |||
| Fasinumab | REGN475, SAR164877, MT-5547 | Nerve growth factor | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Pain due to osteoarthritis of the knee or hip (NCT03161093, NCT02683239, NCT03304379, NCT02447276, NCT03245008); Low back pain (NCT02620020) | Neurological disorders | Regeneron | Teva, Mitsubishi Tanabe Pharma Corporation | ||
| Favezelimab | MK-4280 | LAG-3 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Colorectal cancer (NCT05064059) | Cancer | Merck Sharp & Dohme Corp. | |||
| Felzartamab | TJ202, MOR202, MOR03087 | CD38 | Human mAb | Monospecific | IgG1 | lambda | Phase 3 | Multiple myeloma (NCT03952091) | Cancer | MorphoSys AG | I-Mab Biopharma | |||
| Finotonlimab | SCT-I10A, SCTI-10A | PD-1 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 2/3 and Phase 3 | Hepatocellular carcinoma (NCT04560894); Non-small-cell lung cancer (NCT04171284); Head and neck squamous cell carcinoma (NCT04146402) | Cancer | Sinocelltech Ltd | |||
| Flotetuzumab | MGD006, S80880 | CD123, CD3 | Humanized DART®; Tandem domain-exchanged Fv; bivalent scFv-scFv (VH-VL-VH'-VL') | Bispecific | Phase 2 (pivotal) | Acute myeloid leukemia (NCT04582864) | Cancer | MacroGenics | ||||||
| Gantenerumab | RO4909832, RG1450 | Amyloid beta | Human mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Early Alzheimer's disease (NCT01760005, NCT03444870, NCT03443973); Alzheimer's disease (NCT04339413, NCT04374253) | Neurological disorders | Hoffmann-La Roche | MorphoSys | ||
| Garadacimab | CSL312 | Factor XIIa | Human mAb | Monospecific | IgG4 | lambda | Phase 3 | Prevention of hereditary angioedema attacks (NCT04656418, NCT04739059) | Cardiovascular / hemostasis | CSL Behring | ||||
| Garetosmab | REGN2477 | Activin A | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 2 (pivotal) | Fibrodysplasia ossificans progressiva (NCT03188666) | Musculoskeletal disorders | Regeneron | |||
| Glofitamab | RO7082859, CD20-TCB, RG6026 | CD20, CD3e | CrossMab; Fab-Fc(G1) x Fab-Fab-Fc | Bispecific | IgG1 | lambda/kappa | Hetero HH: S354C-T366W x Y349C-T366S-L368A-Y407V (KiH and extra cysteines); HL-pairing: CrossMab; both chains: L234A, L235A, P329G (Fc-silencing) | Phase 3 | Diffuse large B-cell lymphoma (NCT04408638) | Cancer | Hoffmann-La Roche | |||
| Ianalumab | VAY736 | BLyS/BAFF/TACI/BCMA receptor | Human mAb | Monospecific | IgG1 | kappa | Afucosylated (improve FcγRIIIa binding/improve ADCC) | Phase 2/3 and Phase 3 | Autoimmune hepatitis (NCT03217422); Lupus nephritis (NCT05126277 not yet recruiting) | Immune-mediated disorders | MorphoSys | Novartis | ||
| Inclacumab | RO4905417, RG1512 | P-selectin (CD62) | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization); L235E (impair Fc effector function) | Phase 3 | Vaso-occlusive crisis in sickle cell disease patients (NCT04927247, NCT04935879) | Cardiovascular / hemostasis | Hoffmann-La Roche; Genmab | Global Blood Therapeutics | ||
| Iodine (131I) apamistamab | I-131-BC8, Iomab-B | CD45 | Murine mAb | Monospecific | IgG1 | kappa | I-131 | Phase 3 | Acute myeloid leukemia (NCT02665065) | Cancer | Actinium Pharmaceuticals | |||
| Itepekimab | REGN3500, SAR440340 | IL-33 | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Chronic obstructive pulmonary disease (NCT04751487, NCT04701983) | Respiratory | Regeneron | Sanofi | ||
| Latozinemab | AL001 | Sortilin | Human mAb | Monospecific | IgG1 | kappa | L234A, L235A, P331S (remove Fc effector functions) | Phase 3 | Frontotemporal dementia (NCT04374136) | Neurological disorders | Alector | GlaxoSmithKline | ||
| Lebrikizumab | RG3637, TNX-650, PRO301444, MILR1444A | IL-13 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Atopic dermatitis (NCT04250337, NCT04760314, NCT04146363, NCT04178967, NCT04626297, NCT04392154, NCT04250350) | Immune-mediated disorders | Genentech | Eli Lilly and Company, Almirall | ||
| Lenvervimab | GC1102 | Hepatitis B virus surface antigen | Human mAb | Monospecific | IgG1 | kappa | None found | Phase 2/3 | Prevention of hepatitis B virus infection recurrance after liver transplantation (NCT03519113) | Infectious disease | GC Pharma | |||
| Ligelizumab | QGE031 | IgE | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Chronic spontaneous urticaria (NCT03580356, NCT03580369, NCT03907878, NCT04210843); Chronic inducible urticaria (NCT05024058); Peanut allergy (NCT04984876) | Immune-mediated disorders | Tanox | Novartis | ||
| Lirentelimab, Antolimab | AK002 | Siglec-8 | Humanized mAb | Monospecific | IgG1 | kappa | Afucosylated | Phase 3 | Eosinophilic gastritis and/or eosinophilic duodenitis (NCT04322604, NCT04620811); Eosinophilic duodenitis NCT04856891); Eosinophilic esophagitis (NCT04322708) | Immune-mediated disorders | Allakos, Inc | |||
| Magrolimab | ONO-7913, Hu5F9-G4 | CD47 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Myelodisplastic syndromes (NCT04313881); Acute myeloid leukemia (NCT04778397, NCT05079230 (not yet recruiting)) | Cancer | Gilead Sciences | Ono Pharmaceutical Co | ||
| Marstacimab | PF-06741086 | Tissue factor pathway inhibitor | Human mAb | Monospecific | IgG1 | lambda | L234A, L235A, G237A (impair Fc effector funcctions) | Phase 3 | Severe hemophilia A or B (NCT03938792) | Cardiovascular / hemostasis | Pfizer | |||
| Mirikizumab | LY3074828 | IL-23p19 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization), F234A, L235A (impair Fc effector function) | Phase 3 | Crohn's disease (NCT04232553, NCT03926130): Ulcerative colitis (NCT03519945, NCT03518086, NCT03524092); Crohn's Disease or Ulcerative Colitis (NCT04844606), ; Psoriasis (NCT03482011, NCT03535194, NCT03556202) | Immune-mediated disorders | Eli Lilly and Company | |||
| Monalizumab | NN8765, IPH-2201, NNC141-0100 | NKG2A | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Squamous Cell Carcinoma of the Head and Neck (NCT04590963) | Cancer | Novo Nordisk | AstraZeneca; Innate Pharma | ||
| Tozorakimab | MEDI3506 | IL-33 | Human mAb | Monospecific | IgG1 | lambda2 | Phase 3 | Chronic obstructive pulmonary disease (NCT05166889, NCT05158387 not yet recruiting) | Respiratory | AstraZeneca/MedImmune | ||||
| Navicixizumab | OMP-305B83 | DLL4, VEGF | Humanized, chimeric mAb | Bispecific | IgG2; Hetero H, cL | kappa | Hetero HH: L368E-Y407E x T357K-D399K (bispecific assembly) ; HL-pairing: cL | Phase 3 pending | Ovarian cancer/peritoneal cancer/fallopian tube cancer (NCT05043402 (not yet recruiting)) | Cancer | OncXerna Theraputics, Inc. | |||
| Nipocalimab | M281 | FcRn | Human mAb | Monospecific | IgG1 | lambda | N297A (Fc-aglycosylated) | Phase 2/3 and Phase 3 | Warm autoimmune hemolytic anemia (NCT04119050); Generalized myasthenia gravis (NCT04951622) | Immune-mediated disorders | Janssen | |||
| Sibeprenlimab | VIS649 | APRIL | Humanized mAb | Monospecific | IgG2 | kappa | Phase 2/3 and Phase 3 pending | IgA nephropathy (NCT05248659, NCT05248646) | Otsuka Pharmaceutical | |||||
| Nofazinlimab | CS1003 | PD-1 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Hepatocellular carcinoma (NCT04194775) | Cancer | Cstone Pharmaceuticals | EQRx | ||
| Ociperlimab | BGB-A1217 | TIGIT | Humanized mAb | Monospecific | IgG1 | kappa | Phase 3 | Non-small cell lung cancer (NCT04746924, NCT04866017) | Cancer | BeiGene | ||||
| Odronextamab | REGN1979 | CD20, CD3 | Human mAb | Bispecific | IgG4; Hetero H, cL | kappa | Hetero HH: WT x H435R-Y436F (limits binding to Protein A, purification); HL-pairing: cL ; both chains: E233P, F234V, L235A, G236del (Fc-silencing), S228P (hinge-stabilization) | Phase 2 (potentially pivotal) | Non-Hodgkin lymphoma (NCT03888105) | Cancer | Regeneron | Zai Lab | ||
| Onfekafusp alfa | L19TNF, L19(scFv)2-TNF | Fibronectin extra-domain B | Human mAb | Monospecific | scFv fused with TNF | scFv fused with TNF | Phase 3 | Soft tissue sarcoma (NCT04650984); melanoma (NCT03567889, in combination with L19IL2) | Cancer | Philogen S.p.A. | ||||
| Ongericimab | JS002 | PCSK9 | Humanized mAb | Monospecific | IgG4 | kappa | Phase 3 | Hyperlipidemia (NCT04781114) | Cardiovascular / hemostasis | Shanghai Junshi Bioscience Co Ltd | ||||
| Oregovomab | Mab-B43.13 | CA125 | Murine mAb | Monospecific | IgG1 | kappa | Phase 3 | Ovarian cancer (NCT04498117) | Cancer | Quest PharmaTech Inc. | OncoQuest Pharmaceuticals, Inc. | |||
| Otilimab | GSK3196165, MOR103, MOR-04357 | GM-CSF (aka CSF2) | Human mAb | Monospecific | IgG1 | lambda | Phase 3 | Rheumatoid arthritis (NCT03980483, NCT03970837, NCT04134728, NCT04333147) | Immune-mediated disorders | MorphoSys AG | GlaxoSmithKline | |||
| Pamrevlumab | FG-3019 | Connective tissue growth factor | Human mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Duchenne muscular dystrophy (NCT04632940, NCT04371666); Idiopathic pulmonary fibrosis (NCT04419558, NCT03955146); Pancreatic cancer (NCT03941093, NCT04229004) | Musculoskeletal disorders (secondary areas: Respiratory, Cancer) | FibroGen | |||
| Pozelimab | REGN3918 | Complement C5 | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 2/3 and 3 | CD55-deficient protein-losing enteropathy (NCT04209634); Paroxysmal nocturnal hemoglobinuria (NCT04162470); Generalized myasthenia gravis (NCT05070858 (not yet recruiting)) | Cardiovascular / hemostasis | Regeneron | |||
| Pucotenlimab | HX008 | PD-1 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization), S254T, V308P, N434A (improve FcRn binding) | Phase 2/3 and Phase 3 | Non-small cell lung cancer (NCT04750083); Gastric cancer (NCT04486651) | Cancer | Taizhou Hanzhong Biomedical Co. LTD | |||
| Quavonlimab | MK-1308, AK107 | CTLA-4 | Humanized mAb | Monospecific | IgG1 | kappa | Phase 3 | Renal cell carcinoma (NCT04736706) | Cancer | Akeso Biopharma | Merck Sharp & Dohme Corp. | |||
| Recaticimab | SHR-1209 | PCSK9 | HumanizedmAb | Monospecific | IgG1 | kappa | M252Y, S254T, T256E (half life extension) | Phase 3 | Hypercholesterolemia and hyperlipidemia (NCT04849000, NCT04885218); Primary hypercholesterolemia (NCT04844125) | Cardiovascular / hemostasis | Jiangsu HengRui Medicine Co., Ltd. | |||
| Rozanolixizumab | UCB7665 | FcRn | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge stabilizing) | Phase 3 | Generalized myasthenia gravis (NCT03971422, NCT04124965, NCT04650854); Primary immune thrombocytopenia (NCT04200456, NCT04224688, NCT04596995) | Immune-mediated disorders | UCB Biopharma | |||
| Sabatolimab | MBG453 | TIM-3 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Myelodysplastic syndromes and chronic myelomonocytic leukemia (NCT04266301) | Cancer | Novartis | |||
| Sasanlimab | PF-06801591 | PD-1 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Non-muscle invasive bladder cancer (NCT04165317) | Cancer | Pfizer | |||
| Setrusumab | UX143, BPS804, MOR05813 | Sclerostin | Human mAb | Monospecific | IgG2 | lambda | Phase 2/3 | Osteogenesis imperfecta (NCT05125809) | Musculoskeletal disorders | Ultragenyx Pharmaceutical Inc | Mereo BioPharma | |||
| APX003, BD0801, TK001, sevacizumab | VEGF | Humanized mAb | Monospecific | Phase 3 | Ovarian cancer (NCT04908787) | Cancer | Jiangsu Simcere Pharmaceutical Co., Ltd. | Apexigen | ||||||
| Socazolimab | ZKAB001, STI-A1014 | PD-L1 | Human mAb | Monospecific | IgG1 | lambda2 | Phase 3 | Small-cell lung cancer (NCT04878016); Osteosarcoma (NCT04359550) | Cancer | Sorrento Therapeutics | Lee's Pharmaceutical Holdings | |||
| Solanezumab | LY-2062430, hM266.2 | Amyloid beta, soluble | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 2/3 and Phase 3 | Alzheimer's disease (NCT01760005); Cognition disorders (NCT02008357) | Neurological disorders | Eli Lilly and Company | |||
| Tafolecimab | IBI306 | PCSK9 | Human mAb | Monospecific | IgG2 | kappa | Phase 2/3 or 3 | Hypercholesterolemia (NCT04709536, NCT04289285); Homozygous familial hypercholesterolemia (NCT04948008, NCT04031742); Heterozygous familial hypercholesterolemia (NCT04179669, NCT04759534) | Cardiovascular / hemostasis | Innovent Biologics (Suzhou) Co. Ltd. | ||||
| Talquetamab | JNJ-64407564 | G protein-coupled receptor 5D, CD3 | Humanized mAb | Bispecific DuoBody® | IgG4 | kappa/lambda | Hetero HH: F405L-R409K x WT; both chains: S228P (hinge-stabilization), F234A-L235A (Fc-silencing) | Phase 2 (pivotal) | Multiple myeloma (NCT04634552) | Cancer | Janssen Research & Development, LLC | Genmab | ||
| Tarcocimab | KSI-301 | VEGF | Humanized mAb | Monospecific | IgG1 | kappa | Antibody-biopolymer conjugate (site-specific conjugation of an 800 kDa branched phosphorylcholine biopolymer) | Fc mutations for inert effector function and site specific conjugation | Phase 3 | Diabetic macular edema (NCT04603937, NCT04611152); Macular edema due to retinal vein occlusion (NCT04592419); Wet macular degeneration (NCT04964089, NCT04049266); Non-proliferative diabetic retinopathy (NCT05066230) | Ophthalmic disorders | Kodiak Sciences Inc | ||
| Tebotelimab | MGD013 | PD-1 , LAG-3 | Humanized DART®; Tandem domain-exchanged Fv | Bispecific | IgG4 | kappa | Phase 2/3 | Gastric cancer (NCT04082364) | Cancer | Macrogenics | Zai Lab | |||
| Telisotuzumab vedotin | ABBV-399 | cMet | Humanized mAb | Monospecific | IgG1 | kappa | MMAE | Phase 3 | Non-small cell lung cancer (NCT04928846) | Cancer | AbbVie | |||
| Tiragolumab | MTIG7192A, RO7092284, RG6058 | TIGIT | Human mAb | Monospecific | IgG1 | kappa | Phase 3 | Non-small cell lung cancer (NCT04294810, NCT04513925); Esophageal cancer (NCT04543617, NCT04540211); Small cell lung carcinoma (NCT04665856; NCT04256421) | Cancer | Genentech | ||||
| Tosatoxumab | AR-301, KBSA301 | S. aureus alpha-toxin | Human mAb | Monospecific | IgG1 | lambda | None found | Phase 3 | Ventilator-associated pneumonia caused by S. aureus (NCT03816956) | Infectious disease | Kenta Biotech Ltd | Aridis Pharmaceuticals, Serum AMR | ||
| Trastuzumab duocarmazine | SYD985, 4D5-8 | HER2 | Humanized mAb | Monospecific | IgG1 | kappa | Duocarmycin | Phase 3 | Breast cancer (NCT03262935) | Cancer | Byondis B.V. | |||
| Ivonescimab | AK112 | PD-1, VEGF | mAb | Bispecific | IgG1-(scFv2) | kappa | Phase 3 | Non-small cell lung cancer (NCT05184712) | Cancer | Akesobio Australia Pty Ltd | ||||
| Tusamitamab ravtansine | SAR408701 | CEACAM5 | Humanized mAb | Monospecific | IgG1 | kappa | DM4 | Phase 3 | Non-small cell lung cancer (NCT04154956) | Cancer | ImmunoGen | Sanofi | ||
| Vibostolimab | MK-7684 | TIGIT | Humanized mAb | Monospecific | IgG1 | kappa | - | Phase 3 | Non-small cell lung cancer (NCT04738487) | Cancer | Merck Sharp & Dohme Corp. | |||
| Vunakizumab | SHR-1314 | IL-17A | Humanized mAb | Monospecific | IgG1 | kappa | Phase 2/3 and Phase 3 | Ankylosing spondylitis (NCT04840485); Plaque psoriasis (NCT04839016) | Immune-mediated disorders | Atridia Pty Ltd./ Jiangsu Hengrui Medicine Co. | ||||
| Xeligekimab | GR1501 | IL-17A | Human mAb | Monospecific | IgG4 | kappa | Phase 3 | Plaque psoriasis (ChiCTR2100043223) | Immune-mediated disorders | Genrix (Shanghai) Biopharmaceutical Co. Ltd. | ||||
| Zalifrelimab | AGEN1884 | CTLA-4 | Human mAb | Monospecific | IgG1 | kappa | - | Phase 2 (pivotal) | Cervical cancer (NCT03894215) | Cancer | Agenus Inc. | Betta Pharmaceuticals, Recepta biopharma | ||
| Zamerovimab + mazorelvimab | SYN023 (mixture of CTB011 + CTB012) | Rabies virus spike glycoprotein | Mixture of 2 humanized mAbs | Two monospecific mAbs | IgG1 | kappa | Phase 3 | Rabies (NCT04644484) | Infectious disease | Synermore Biologics Co. Ltd. | ||||
| Zanidatamab | ZW25 | HER2, HER2 (biparatopic) | Humanized mAb | Bispecific; scFv-Fc(G1) x Fab-Fc | IgG1 | kappa | Hetero HH: T350V-L351Y-F405A-Y407V x T350V-T366L-K392L-T394W | Phase 2 (pivotal) and Phase 3 | Biliary tract cancers (NCT04466891); Gastroesophageal adenocarcinoma cancer (HERIZON-GEA-01) | Cancer | Zymeworks | BeiGene | ||
| Zolbetuximab | iMAB362, Claudiximab, GC-182 | Claudin-18.2 | Chimeric mAb | Monospecific | IgG1 | kappa | - | Phase 3 | Gastric and gastro-esophageal junction adenocarcinoma (NCT03504397, NCT03653507) | Cancer | Astellas | |||
| AFM13 | CD30, CD16A | Human mAb; TandAb (tetravalent bispecific molecule comprising antibody variable domains with two binding sites for each antigen) | Bispecific; Tetravalent | - | - | Phase 2 (pivotal) | Peripheral T-cell lymphoma or transformed mycosis fungoides (NCT04101331) | Cancer | Affimed | |||||
| ANX005 | Complement C1q | Humanized mAb | Monospecific | IgG4 | Phase 2/3 | Guillain-Barré syndrome (NCT04701164) | Cardiovascular / hemostasis | Annexon Biosciences | ||||||
| ARX788 | HER2 | Humanized mAb | Monospecific | IgG1 | Amberstatin 269 (Auroxime) | Phase 2 (pivotal), Phase 2/3, Phase 3 | Breast cancer (NCT04829604, ACE-Breast-02 (China)); Gastric cancer (ACE-Gastric-02 (China)) | Cancer | Ambrx | NovoCodex Biopharmaceuticals Co. Ltd, Zhejiang Medicine Co. Ltd | ||||
| Litifilimab | BIIB059 | Blood dendritic cell antigen 2 (CD303; CLEC4C) | Humanized mAb | Monospecific | IgG1 | kappa | Phase 3 | Systemic lupus erythematosus (NCT04961567, NCT04895241) | Immune-mediated disorders | Biogen | ||||
| CBT-502, TQB2450, APL-502 | PD-L1 | Humanized mAb | Monospecific | IgG1 | Fc silenced | Phase 3 | Renal cancer (NCT04523272); Non-small cell lung cancer (NCT04325763, NCT04964479); Squamous cell carcinoma of the head and neck (NCT03855384); Biliary cancer (NCT04809142) | Cancer | CBT Pharmaceuticals, Inc | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
| IBI310 | CTLA-4 | Humanized mAb | Monospecific | IgG1 | Phase 3 | Melanoma (NCT04277663); Hepatocellular carcinoma (NCT04720716) | Cancer | Innovent Biologics, Inc | ||||||
| INBRX-109 | DR5 | Humanized mAb; sdAb (heavy chain only antibodies) fused to Fc | Monospecific; Tetravalent | IgG1 | Fc silenced | Phase 2 (potentially pivotal) | Chondrosarcoma (NCT04950075) | Cancer | Inhibrx, Inc. | |||||
| JY-025 | VEGFR2 | Human mAb | Monospecific | Phase 2/3 pending | Non-small cell lung cancer (NCT04874844 (not yet recruiting)) | Cancer | Beijing Dongfang Biotech Co., Ltd. | |||||||
| MIL62 | CD20 | Humanized mAb | Monospecific | IgG1 | kappa | Afucosylated | Phase 3 | Follicular lymphoma and marginal zone lymphoma (NCT04834024) | Cancer | Beijing Mabworks Biotech Co., Ltd. | ||||
| Clesrovimab | MK-1654 | RSV fusion protein | Human mAb | Monospecific | IgG1 | kappa | M252Y, S254T, T256E (half life extension) | Phase 2/3 and Phase 3 | Reduction in incidence of respiratory syncytial virus infection (NCT04767373, NCT04938830) | Infectious disease | Merck Sharp & Dohme Corp. | |||
| NIS793, XOMA-089 | TGF beta 1 and 2 | Human mAb | Monospecific | IgG2 | Phase 3 | Pancreatic ductal adenocarcinoma (NCT04935359) | Cancer | XOMA Corporation | Novartis | |||||
| NNC0365-3769, Mim8 | FIXa, FX | Human mAb | Bispecific | IgG4 | Phase 3 | Hemophilia A with or without inhibitors (NCT05053139) | Cardiovascular / hemostasis | Novo Nordisk A/S | ||||||
| QL1604 | PD-1 | mAb | Monospecific | Phase 2/3 | Cervical cancer (NCT04864782) | Cancer | Qilu Pharmaceutical Co., Ltd. | |||||||
| REGN1908-1909 | Fel d 1 | Mixture of 2 human mAbs | Two monospecific mAbs | IgG4 | S228P (hinge stabilizing) | Phase 3 | Cat allergy (NCT04981717) | Immune-mediated disorders | Regeneron | |||||
| Linvoseltamab | REGN5458 | BCMA, CD3 | Human mAb | Bispecific | IgG4; Hetero H, cL | Hetero HH: WT x H435R-Y436F (limits binding to Protein A, purification); HL-pairing: cL; both chains: E233P, F234V, L235A, G236del (Fc-silencing) | Phase 2 (potentially pivotal) | Multiple myeloma (NCT03761108) | Cancer | Regeneron | ||||
| REGN5713-5714-5715 | Bet v1 | Mixture of 3 human mAbs | Three monospecific antibodies against three different epitopes | IgG4 | kappa | S228P (hinge stabilizing) | Phase 3 | Seasonal allergic rhinitis (NCT04709575) | Immune-mediated disorders | Regeneron | ||||
| RO7204239, GYM329, RG6237 | Myostatin | Humanized mAb | Monospecific | IgG1 | Specific mutations not found; engineered for selective and enhanced binding to the human FcγRIIb and for stronger affinity to FcRn in acidic pH conditions | Phase 2/3 | Spinal muscular atrophy (NCT05115110) | Musculoskeletal disorders | Chugai | Roche | ||||
| Retlirafusp alfa | SHR-1701 | PD-L1, TGF-β | Antibody-receptor fusion | Bispecific | IgG4 | kappa | Extracellular domain of human TGF-β receptor II | S228P (hinge-stabilization) | Phase 2/3; Phase 3 | Colorectal cancer (NCT04856787); Gastric or gastroesophageal junction cancer (NCT04950322); Non-small cell lung cancer (NCT05132413 (not yet recruiting)) | Cancer | Jiangsu HengRui Medicine Co., Ltd. | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | |
| Izalontamab | SI-B001 | EGFR, HER3 | IgG-(scFv)2 | Bispecific | Phase 2/3 | Non-small cell lung cancer (NCT05020457, NCT05020769) | Cancer | Biokin | Sichuan Baili Pharmaceutical Co. Ltd, SystImmune Inc. | |||||
| Suciraslimab | SM03 | CD22 | Chimeric mAb | Monospecific | IgG1 | kappa | Phase 3 | Rheumatoid arthritis (NCT04312815) | Immune-mediated disorders | Shenzhen Lonn Ryonn | SinoMab BioScience Limited | |||
| Semzuvolimab | UB-421, dB4C7 | CD4 | Humanized mAb | Monospecific | IgG1 | kappa | N297H (Fc-aglycosylated to remove Fc effector function) | Phase 3 | HIV infection (NCT04406727, NCT03149211 (not yet recruiting)) | Infectious disease | United Biopharma | |||
| Nadunolimab | CAN04 | IL1 Receptor Accessory Protein | Humanized mAb | Monospecific | IgG1 | kappa | Phase 2/3 pending | Pancreatic cancer (NCT04229004) | Cancer | Cantargia AB | Pancreatic Cancer Action Network | |||
| Crexavibart and ogalvibart | C144-LS and C-135-LS | SARS-CoV-2 | Mixture of 2 mAbs | Two monospecific antibodies | IgG1 | M428L/N434S (extends half-life) | Phase 2/3 | COVID-19/SARS-CoV-2 infection (NCT04518410) | Infectious disease | Bristol-Myers Squibb | Rockefeller University | |||
| MW33, 9MW3311, ABP-300 | SARS-CoV-2 | Human mAb | Monospecific | IgG1 | kappa | L234A/L235A (impair Fc effector functions) | Phase 2/3 | COVID-19/SARS-CoV-2 infection | Infectious disease | Mabwell (Shanghai) Bioscience Co., Ltd. | Abpro Corporation | |||
| Adintrevimab | ADG20 | SARS-CoV-2 | Human mAb | Monospecific | IgG1 | lambda2 | M428L/N434A (extend half-life) | Phase 2/3 | COVID-19/SARS-CoV-2 infection (NCT04859517, NCT04805671) | Infectious disease | Adagio | |||
| Upanovimab | SCTA01, monotherapy and in combination with SCTA01C | SARS-CoV-2 | Humanized mAb | Monospecific | IgG1 | kappa | L234A/L235A (impair Fc effector functions) | Phase 2/3 | COVID-19/SARS-CoV-2 infection (NCT04644185) | Infectious disease | Sinocelltech Ltd. | |||
| MAD0004J08 | SARS-CoV-2 | Human mAb | Monospecific | IgG1 | M428L /N434S (extends half-life) L234A/L235A/P329G (impair Fc effector functions) | Phase 2/3 | COVID-19/SARS-CoV-2 infection (NCT04952805) | Infectious disease | Toscana Life Sciences Sviluppo s.r.l. | |||||
| ADM03820 (COV2-2130-YTE-LALA + COV2-2381-YTE124 LALA) | SARS-CoV-2 | Mixture of 2 human mAbs | Two monospecific antibodies | IgG1 | M252Y/S254T/T256E (extends half-life); L234A/L235A (reduces Fc effector functions) | Phase 2/3 pending | COVID-19/SARS-CoV-2 infection (NCT05142527) | Infectious disease | Ology Bioservices / Evotec | |||||
| TY027 | SARS-CoV-2 | Human mAb | Monospecific | IgG | Phase 3 | COVID-19/SARS-CoV-2 infection (NCT04649515) | Infectious disease | Tychan | ||||||
| Vilobelimab | BDB-001, IFX-1, CaCP29 | Complement 5a | Chimeric mAb | Monospecific | IgG4 | kappa | Phase 3 | Hidradenitis suppurativa; COVID-19 (NCT04449588) | Hemostasis | Inflarx | Staidson (Beijing) Biopharmaceuticals Co., Ltd | |||
| Lenzilumab | GM-CSF | Human mAb | Monospecific | IgG1 | kappa | Phase 3 | COVID-19 pneumonia (NCT04351152, NCT04583969) | Respiratory | Humanigen | |||||
| Plonmarlimab | TJ003234, TJM2 | GM-CSF | Humanized mAb | Monospecific | IgG1 | kappa | Phase 2/3 | COVID-19-related cytokine release syndrome (NCT04341116) | Infectious disease | I-Mab Biopharma Co. Ltd. | ||||
| Glenzocimab | ACT017 | Glycoprotein VI on platelets | Humanized Fab | Monospecific | IgG1 | kappa | Phase 2/3 | Acute ischemic stroke (NCT05070260) | Cardiovascular disease | Acticor Biotech | ||||
| Paridiprubart | EB05, NI-0101 | Toll-like receptor 4 | Humanized mAb | Monospecific | IgG1 | kappa | Phase 2/3 | COVID-19-related acute respiratory distress syndrome (NCT04401475) | Respiratory | NovImmune SA | Edesa Biotech | |||
| HP6H8, meplazumab | CD147 | Humanized mAb | Monospecific | IgG2 | Phase 2/3 | COVID-19 | Infectious disease | Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | ||||||
| E2814 | Tau | Humanized mAb | Monospecific | IgG1 | Phase 2/3 | Dominantly inherited Alzheimer's Disease (NCT05269394) | Neurological disorders | Eisai Co., Ltd. | ||||||
| Ebronucimab | AK102 | PCSK9 | Human mAb | Monospecific | IgG1 | lambda2 | Phase 3 | Primary hypercholesterolemia and mixed hyperlipidemia (NCT05255094, NCT05260411) | Cardiovascular/hemostasis | Akesobio Australia Pty Ltd | Dawnrays Pharmaceutical (Holdings) Limited | |||
| Imsidolimab | ANB019 | IL-36R | Humanized mAb | Monospecific | IgG4 | kappa | Phase 3 | Generalized pustular psoriasis (GEMINI-1) | Immune-mediated disorders | AnaptysBio, Inc. | ||||
| Ivuxolimab | PF-04518600 | OX40 | Human mAb | Monospecific | IgG2 | kappa | Phase 3 | Advanced malignancies (NCT05059522) | Cancer | Pfizer Inc. | ||||
| Oleclumab | MEDI9447 | CD73 | Human mAb | Monospecific | IgG1 | lambda1 | Phase 3 | Non-small cell lung cancer (NCT05221840) | Cancer | AstraZeneca | ||||
| Patritumab deruxtecan | U3-1402 | HER3 | Human mAb | Monospecific | IgG1 | kappa | DXd/DX-8951 | Phase 3 | Epidermal growth factor receptor-mutated non-small cell lung cancer (NCT05338970) | Cancer | Daiichi Sankyo Co., Ltd | |||
| Ziltivekimab | COR-001 | IL-6 | Human mAb | Monospecific | IgG1 | kappa | Phase 3 | Atherosclerotic cardiovascular disease, chronic kidney disease (NCT05021835) | Cardiovascular/hemostasis | AstraZeneca | Novo Nordisk A/S | |||
| CM310 | IL-4Rα | Humanized mAb | Monospecific | Phase 3 pending | Atopic dermatitis (NCT05265923 pending) | Immune-mediated disorders | Keymed Biosciences Co.Ltd | |||||||
| CT-P63 and CT-P61 | SARS-CoV-2 spike protein | mAb | Mixture of 2 monospecific mAbs | Phase 3 pending | COVID-19 (NCT05224856 pending) | Infectious disease | Celltrion | |||||||
| Fianlimab | REGN3767 | LAG-3 | Human mAb | Monospecific | IgG4 | kappa | Hinge-stabilized | Phase 3 pending | Melanoma (NCT05352672 pending) | Cancer | Regeneron Pharmaceuticals | Sanofi | ||
| Futuximab+modotuximab | SYM004 | EGFR | Chimeric mAbs | Mixture of 2 monospecific mAbs | IgG1 | kappa | Phase 3 pending | Colorectal cancer (NCT05223673 pending) | Cancer | Institut de Recherches Internationales Servier | ||||
| Suvratoxumab | AR-320, MEDI4893 | Staphylococcus aureus alpha toxin | Human mAb | Monospecific | IgG1 | kappa | YTE mutations | Phase 3 pending | Ventilator Associated Pneumonia caused by Staph aureus (NCT05331885 pending) | Infectious disease | AstraZeneca | Aridis | ||
| Tagitanlimab | A167, KL-A167, KLA-167, HBM9167 | PD-L1 | Humanized mAb | Monospecific | IgG1 | kappa | Phase 3 pending | Nasopharyngeal carcinoma (NCT05294172 pending) | Cancer | Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Klus Pharma, Harbour BioMed | |||
| Upifitamab rilsodotin | XMT-1536 | NaPi2b | Humanized mAb | Monospecific | IgG1 | kappa | Auristatin F-hydroxypropylamide | Phase 3 pending | Ovarian cancer (NCT05329545 pending) | Cancer | Mersana Therapeutics | |||
