sotatercept-csrk

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

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

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

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

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

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

5469

72203

90550690

Telangiectasia

146.24

29.26

5524

1353

90621540

Headache

112.90

29.26

194

5360

862552

89760341

Platelet count decreased

106.96

29.26

5475

136890

90486003

Vascular device infection

93.49

29.26

5521

11919

90610974

Gastrointestinal haemorrhage

77.09

29.26

5499

90193

90532700

Flushing

73.45

29.26

5501

88438

90534455

Pain in jaw

70.10

29.26

5513

47944

90574949

Device occlusion

66.43

29.26

5530

9258

90613635

Product administration interrupted

62.97

29.26

5529

12467

90610426

Dyspnoea

61.26

29.26

153

5401

880802

89742091

Haematocrit increased

59.73

29.26

5537

3061

90619832

Complication associated with device

55.39

29.26

5528

19423

90603470

Laboratory test abnormal

53.95

29.26

5521

41821

90581072

Hospitalisation

50.58

29.26

5504

128050

90494843

Dizziness

49.13

29.26

110

5444

589174

90033719

Pulmonary hypertension

48.44

29.26

5523

42492

90580401

Diarrhoea

48.17

29.26

146

5408

939044

89683849

Haemoptysis

44.81

29.26

5527

33293

90589600

Pulmonary arteriovenous fistula

43.64

29.26

5548

90622874

Ventilation perfusion mismatch

40.67

29.26

5545

583

90622310

Drug delivery system malfunction

37.81

29.26

5544

1371

90621522

Drug ineffective

34.89

29.26

5533

1384277

89238616

Gingival bleeding

33.64

29.26

5537

14886

90608007

Hypotension

31.93

29.26

5489

325332

90297561

Hypoxia

31.83

29.26

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

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

1253

5136

42614876

Epistaxis

90.07

40.55

1280

66783

42553229

Pericardial effusion

58.99

40.55

1298

29250

42590762

Infusion site pain

57.22

40.55

1307

5379

42614633

Gastrointestinal haemorrhage

54.02

40.55

1288

97691

42522321

Dyspnoea exertional

43.40

40.55

1299

50124

42569888

Headache

42.20

40.55

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

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

3821

9079

110576331

Epistaxis

242.38

32.05

109

3780

130263

110455147

Dyspnoea exertional

129.06

32.05

3823

103994

110481416

Headache

91.48

32.05

132

3757

882245

109703165

Telangiectasia

88.70

32.05

3870

1858

110583552

Device occlusion

79.55

32.05

3862

15158

110570252

Product administration interrupted

79.04

32.05

3864

11267

110574143

Vascular device infection

69.72

32.05

3864

16487

110568923

Gastrointestinal haemorrhage

59.32

32.05

3841

165470

110419940

Pulmonary arteriovenous fistula

54.16

32.05

3882

110585385

Dyspnoea

53.75

32.05

119

3770

1106753

109478657

Drug delivery system malfunction

46.21

32.05

3879

1025

110584385

Diarrhoea

43.86

32.05

112

3777

1139393

109446017

Flushing

43.15

32.05

3856

104703

110480707

Pain in jaw

42.65

32.05

3864

51152

110534258

Infusion site pain

40.14

32.05

3872

17402

110568008

Complication associated with device

37.83

32.05

3872

20056

110565354

Platelet count decreased

37.02

32.05

3846

230400

110355010

Haemoptysis

35.05

32.05

3864

71329

110514081

Dizziness

34.77

32.05

3813

698117

109887293

Hospitalisation

32.44

32.05

3857

142461

110442949

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

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

Disease	Relation	SNOMED_ID	DOID
Pulmonary arterial hypertension	indication	11399002

Disease

Relation

SNOMED_ID

DOID

Pulmonary arterial hypertension

indication

11399002

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	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

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

11.17

DRUG LABEL

Inhibin beta A chain

Secreted

P08476

INHBA_HUMAN

INHIBITOR

11.34

DRUG LABEL

Inhibin beta B chain

Secreted

P09529

INHBB_HUMAN

INHIBITOR

11.97

DRUG LABEL

Bone morphogenetic protein 10

Secreted

O95393

BMP10_HUMAN

INHIBITOR

11.11

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

Source

CHEMBL1743073

ChEMBL_ID

DB12118

DRUGBANK_ID

4043056

VANDF

4043057

VANDF

C5911057

UMLSCUI

CHEBI:750150