All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

sotatercept-csrk 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
receptor molecules or membrane ligands, native, modified or synthetic	5815	None

Description:

Molecule	Description
Molfile Synonyms: sotatercept sotatercept-csrk winrevair ACE-011 MK-7692	Sotatercept-csrk is a recombinant fusion protein consisting of the extracellular domain of human activin receptor type IIA (ActRIIA) linked to the Fc portion of human IgG1. Sotatercept-csrk functions as an activin signaling ligand trap. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
March 26, 2024	FDA	Merck Sharp & Dohme LLC
Aug. 22, 2024	EMA	Merck Sharp & Dohme B.V.
June 24, 2025	PMDA	MSD K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Haemoglobin increased	761.96	29.26	157	5397	7324	90615569
Epistaxis	408.98	29.26	164	5390	84961	90537932
Pericardial effusion	388.49	29.26	127	5427	36706	90586187
Dyspnoea exertional	171.13	29.26	85	5469	72203	90550690
Telangiectasia	146.24	29.26	30	5524	1353	90621540
Headache	112.90	29.26	194	5360	862552	89760341
Platelet count decreased	106.96	29.26	79	5475	136890	90486003
Vascular device infection	93.49	29.26	33	5521	11919	90610974
Gastrointestinal haemorrhage	77.09	29.26	55	5499	90193	90532700
Flushing	73.45	29.26	53	5501	88438	90534455
Pain in jaw	70.10	29.26	41	5513	47944	90574949
Device occlusion	66.43	29.26	24	5530	9258	90613635
Product administration interrupted	62.97	29.26	25	5529	12467	90610426
Dyspnoea	61.26	29.26	153	5401	880802	89742091
Haematocrit increased	59.73	29.26	17	5537	3061	90619832
Complication associated with device	55.39	29.26	26	5528	19423	90603470
Laboratory test abnormal	53.95	29.26	33	5521	41821	90581072
Hospitalisation	50.58	29.26	50	5504	128050	90494843
Dizziness	49.13	29.26	110	5444	589174	90033719
Pulmonary hypertension	48.44	29.26	31	5523	42492	90580401
Diarrhoea	48.17	29.26	146	5408	939044	89683849
Haemoptysis	44.81	29.26	27	5527	33293	90589600
Pulmonary arteriovenous fistula	43.64	29.26	6	5548	19	90622874
Ventilation perfusion mismatch	40.67	29.26	9	5545	583	90622310
Drug delivery system malfunction	37.81	29.26	10	5544	1371	90621522
Drug ineffective	34.89	29.26	21	5533	1384277	89238616
Gingival bleeding	33.64	29.26	17	5537	14886	90608007
Hypotension	31.93	29.26	65	5489	325332	90297561
Hypoxia	31.83	29.26	30	5524	72369	90550524

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Haemoglobin increased	357.02	40.55	70	1253	5136	42614876
Epistaxis	90.07	40.55	43	1280	66783	42553229
Pericardial effusion	58.99	40.55	25	1298	29250	42590762
Infusion site pain	57.22	40.55	16	1307	5379	42614633
Gastrointestinal haemorrhage	54.02	40.55	35	1288	97691	42522321
Dyspnoea exertional	43.40	40.55	24	1299	50124	42569888
Headache	42.20	40.55	44	1279	239325	42380687

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pericardial effusion	411.83	32.05	129	3760	57088	110528322
Haemoglobin increased	296.97	32.05	68	3821	9079	110576331
Epistaxis	242.38	32.05	109	3780	130263	110455147
Dyspnoea exertional	129.06	32.05	66	3823	103994	110481416
Headache	91.48	32.05	132	3757	882245	109703165
Telangiectasia	88.70	32.05	19	3870	1858	110583552
Device occlusion	79.55	32.05	27	3862	15158	110570252
Product administration interrupted	79.04	32.05	25	3864	11267	110574143
Vascular device infection	69.72	32.05	25	3864	16487	110568923
Gastrointestinal haemorrhage	59.32	32.05	48	3841	165470	110419940
Pulmonary arteriovenous fistula	54.16	32.05	7	3882	25	110585385
Dyspnoea	53.75	32.05	119	3770	1106753	109478657
Drug delivery system malfunction	46.21	32.05	10	3879	1025	110584385
Diarrhoea	43.86	32.05	112	3777	1139393	109446017
Flushing	43.15	32.05	33	3856	104703	110480707
Pain in jaw	42.65	32.05	25	3864	51152	110534258
Infusion site pain	40.14	32.05	17	3872	17402	110568008
Complication associated with device	37.83	32.05	17	3872	20056	110565354
Platelet count decreased	37.02	32.05	43	3846	230400	110355010
Haemoptysis	35.05	32.05	25	3864	71329	110514081
Dizziness	34.77	32.05	76	3813	698117	109887293
Hospitalisation	32.44	32.05	32	3857	142461	110442949

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C02KX06	CARDIOVASCULAR SYSTEM ANTIHYPERTENSIVES OTHER ANTIHYPERTENSIVES Antihypertensives for pulmonary arterial hypertension
MeSH PA	D002317	Cardiovascular Agents
FDA EPC	N0000194100	Activin Signaling Inhibitor
FDA MoA	N0000194101	Activin Signaling Inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:35674	antihypertensive agent
CHEBI has role	CHEBI:75835	anti-anaemic agent
CHEBI has role	CHEBI:233423	antifibrotic agent

Related Drugs by ATC class:

C02KX Antihypertensives for pulmonary arterial hypertension 6 drugs

ambrisentanbosentanmacitentanriociguatsitaxentantadalafil

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Pulmonary arterial hypertension	indication	11399002

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Growth/differentiation factor 11	Cytokine	O95390	GDF11_HUMAN	INHIBITOR	Kd	11.17		DRUG LABEL	DRUG LABEL
Inhibin beta A chain	Secreted	P08476	INHBA_HUMAN	INHIBITOR	Kd	11.34		DRUG LABEL	DRUG LABEL
Inhibin beta B chain	Secreted	P09529	INHBB_HUMAN	INHIBITOR	Kd	11.97		DRUG LABEL	DRUG LABEL
Bone morphogenetic protein 10	Secreted	O95393	BMP10_HUMAN	INHIBITOR	Kd	11.11		DRUG LABEL	DRUG LABEL

External reference:

ID	Source
CHEMBL1743073	ChEMBL_ID
DB12118	DRUGBANK_ID
4043056	VANDF
4043057	VANDF
C5911057	UMLSCUI
CHEBI:750150	CHEBI
1001080-50-7	SECONDARY_CAS_RN
962	PUBCHEM_CID
384190	MMSL
42739	MMSL
d10178	MMSL
019707	NDDF
12962	IUPHAR_LIGAND_ID
9188	INN_ID
2678930	RXNORM
933398421000036106	SNOMEDCT_US
C542017	MESH_SUPPLEMENTAL_RECORD_UI
D09670	KEGG_DRUG
0QI90BTJ37	UNII

Pharmaceutical products:

None