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Bimagrumab
Monoclonal antibody
Type	?
Source	Human
Target	ACVR2B
Clinical data
Other names	BYM338
ATC code	none
Identifiers
CAS Number	1356922-05-8
ChemSpider	none
UNII	N15SW1DIV8
KEGG	D10620^Y
Chemical and physical data
Formula	C₆₃₀₆H₉₇₃₂N₁₆₈₄O₁₉₉₀S₄₆
Molar mass	142451.78 g·mol⁻¹

Bimagrumab (BYM338) is a human monoclonal antibody developed by Novartis to treat pathological muscle loss and weakness. It binds to and inhibits activin receptor type-2B.^[1]

Bimagrumab must be administered intravenously at a hospital or clinic. The medication has a long half life and is administered once a month.^[2]

Development history

On August 20, 2013, it was announced that bimagrumab had received a breakthrough therapy designation for sporadic inclusion body myositis (sIBM) by the US Food and Drug Administration.^[3]

In 2014, Bimagrumab entered Phase II development, with some research indicating clinical effects.^[4] Novartis planned to apply in 2016 for FDA approval to treat sIBM patients with bimagrumab.^[5]

In April 2016, Novartis announced that bimagrumab had failed a Phase IIb/III study for sporadic inclusion body myositis.^[6] In January 2021, a new study confirmed that treatment with Bimagrumab is safe and effective for treating excess adiposity and metabolic disturbances of adult patients with obesity and type 2 diabetes.^[7] In January 2023 the medication entered phase IIb trials for obesity.^[2]

References

^ Garito T, Zakaria M, Papanicolaou DA, Li Y, Pinot P, Petricoul O, et al. (June 2018). "Effects of bimagrumab, an activin receptor type II inhibitor, on pituitary neurohormonal axes". Clinical Endocrinology. 88 (6): 908–919. doi:10.1111/cen.13601. PMID 29566437. S2CID 5019650.
^ ^a ^b GlobalData Healthcare (2023-01-17). "Versanis' bimagrumab, first-in-class obesity therapy, enters Phase IIb of development". Pharmaceutical Technology. Retrieved 2023-05-27.
^ "Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)". Novartis AG. 23 August 2013. Archived from the original on 19 February 2014. Retrieved 20 August 2013.
^ Amato AA, Sivakumar K, Goyal N, David WS, Salajegheh M, Praestgaard J, et al. (December 2014). "Treatment of sporadic inclusion body myositis with bimagrumab". Neurology. 83 (24): 2239–2246. doi:10.1212/WNL.0000000000001070. PMC 4277670. PMID 25381300.
^ "Novartis: Planned filings 2015 to >=2019" (PDF). Novartis Investor Presentation. 27 January 2015. Archived from the original (PDF) on 7 February 2015. Retrieved 27 May 2015.
^ Carroll J (21 April 2016). "Novartis' 'breakthrough' muscle drug bimagrumab flunks a late-stage trial". Fierce Biotech.
^ "Medication shows promise for weight loss in patients with obesity, diabetes". EurekAlert!. Retrieved 2021-01-20.

Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems

Bone

Human	Burosumab Denosumab
Humanized	Blosozumab^† Romosozumab

Musculoskeletal

Human	Stamulumab^†

Circulatory

Human	Abelacimab Alirocumab Ascrinvacumab^§ Bentracimab^† Enoticumab Evinacumab Evolocumab Icrucumab Inclacumab Marstacimab Nesvacumab Orticumab Ramucirumab Rinucumab
Mouse	Biciromab^‡ Imciromab^‡
Chimeric	Abciximab Volociximab
Humanized	Alacizumab pegol Bevacizumab/Ranibizumab Bococizumab Brolucizumab Caplacizumab Concizumab Demcizumab Emicizumab Etaracizumab Faricimab Idarucizumab Ralpancizumab Tadocizumab Vanucizumab

Neurologic

Human	Anti-amyloid drugs Aducanumab^‡ Donanemab Gantenerumab^† Lecanemab Erenumab Fasinumab^† Fulranumab Opicinumab
Humanized	Bapineuzumab^† Crenezumab^† Eptinezumab Fremanezumab Galcanezumab Ozanezumab Ponezumab Refanezumab Semorinemab Solanezumab Tanezumab^†

Angiogenesis inhibitor

Humanized	Ranibizumab

Growth factor

Human	Bimagrumab Trevogrumab
Humanized	Domagrozumab Landogrozumab

^#WHO-EM
^‡Withdrawn from market
Clinical trials:
- ^†Phase III
- ^§Never to phase III

Monoclonal antibodies for the immune system

Immune system

Human	Immunosuppression: Abrilumab Adalimumab^# Anifrolumab Atorolimumab Avelumab Avdoralimab Belimumab Bleselumab Brodalumab Camidanlumab tesirine Carlumab Cemiplimab Dupilumab Eldelumab Emapalumab Fresolimumab Golimumab Ianalumab^† Lanadelumab Lenzilumab Lerdelimumab Lirentelimab Lirilumab Mavrilimumab Metelimumab Morolimumab Namilumab Oleclumab Oxelumab§ Pamrevlumab Placulumab Relatlimab^† Sarilumab Sifalimumab Tabalumab Tezepelumab Ulocuplumab Varlilumab Immune activation: Ipilimumab Durvalumab Nivolumab Tremelimumab Urelumab Other: Bertilimumab Ontamalimab Zanolimumab Combination: Nivolumab/relatlimab
Mouse	Afelimomab Elsilimomab Faralimomab Gavilimomab Inolimomab Maslimomab Nerelimomab Odulimomab Telimomab aritox Vepalimomab Zolimomab aritox
Chimeric	Andecaliximab^† Basiliximab Clenoliximab Galiximab Gomiliximab Infliximab Keliximab Lumiliximab Priliximab Teneliximab Vapaliximab
Humanized	Immunosuppressive: Apolizumab^§ Aselizumab Atezolizumab Benralizumab Camrelizumab^† Cedelizumab Certolizumab pegol Crizanlizumab Daclizumab Eculizumab Efalizumab^‡ Epratuzumab Erlizumab Etrolizumab^† Fontolizumab Frexalimab^† Inebilizumab Itolizumab Lampalizumab^† Letolizumab Ligelizumab^† Lulizumab pegol Mepolizumab Mogamulizumab Natalizumab Ocrelizumab (+hyaluronidase) Omalizumab Ozoralizumab Pascolizumab Pateclizumab Pembrolizumab Pexelizumab Pidilizumab Plozalizumab PRO 140^† Quilizumab Ravulizumab Reslizumab Retifanlimab Rontalizumab Rovelizumab Ruplizumab Samalizumab Satralizumab Siplizumab Spartalizumab^† Talizumab Teclistamab Teplizumab Tislelizumab Tocilizumab Toralizumab Tregalizumab Vatelizumab Vedolizumab Visilizumab Vobarilizumab TGN1412^§ Immune activation: Dostarlimab Other: Ibalizumab
Chimeric + humanized	Otelixizumab Rozanolixizumab Sutimlimab

Interleukin

Human	Bermekimab Brazikumab Briakinumab Canakinumab Fezakinumab Fletikumab Guselkumab Secukinumab Sirukumab Tralokinumab Ustekinumab
Humanized	Anrukinzumab Bimekizumab Clazakizumab Gevokizumab Ixekizumab Mirikizumab^† Lebrikizumab Olokizumab^† Perakizumab Risankizumab Spesolimab Tildrakizumab
Veterinary	Lokivetmab

Inflammatory lesions

Mouse	Besilesomab Fanolesomab^‡ Lemalesomab Sulesomab

^#WHO-EM
^‡Withdrawn from market
Clinical trials:
- ^†Phase III
- ^§Never to phase III

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