Garetosmab

Summary

Garetosmab (CHEMBL4298176) is a phase-3 clinical-stage antibody; indicated across 2 conditions including myositis ossificans and inclusion body myositis.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Indications: 2 conditions
• Clinical trials: 10

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4298176
Name	Garetosmab
Type	Antibody
Max phase	3

Also known as: Garetosmab, REGN-2477, REGN2477, GARETOSMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
myositis ossificans	3	MONDO:0003964	MONDO:0007606
inclusion body myositis	2	MONDO:0007827	EFO:0007323

Clinical trials

Total trials: 10.

Phase distribution

Phase	Trials
PHASE3	3
PHASE2	3
PHASE1	3
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05394116	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)
NCT07559513	PHASE3	NOT_YET_RECRUITING	A Study to Investigate the Safety, Pharmacokinetics (PK), and Efficacy of Garetosmab in Children and Adolescents With Fibrodysplasia Ossificans Progressiva (FOP)
NCT04577820	PHASE3	WITHDRAWN	Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
NCT06299098	PHASE2	ACTIVE_NOT_RECRUITING	A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss, Fat Loss, and Lean Mass Preservation
NCT03188666	PHASE2	COMPLETED	A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
NCT03710941	PHASE2	WITHDRAWN	Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis
NCT02870400	PHASE1	COMPLETED	A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477
NCT02943239	PHASE1	COMPLETED	Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men
NCT06970405	PHASE1	WITHDRAWN	Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women
NCT07301450	Not specified	TEMPORARILY_NOT_AVAILABLE	An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).