Myositis ossificans

Summary

Myositis ossificans (MONDO:0003964) is a disease and 23 clinical trials. Top therapeutic interventions include palovarotene, midazolam, and garetosmab. A subtype of myositis disease — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Clinical trials: 23

Clinical features

No curated clinical features (Orphanet) for this disease.

Identifiers

Disease identifiers

Field	Value
Canonical name	myositis ossificans
Mondo ID	MONDO:0003964
MeSH	D009221
DOID	DOID:668
ICD-11	635062595
NCIT	C3253
UMLS	C0027122
MedGen	6503
GARD	0023755
Is cancer (heuristic)	no

Also known as: fibrodysplasia ossificans progressiva · FOP · myositis ossificans progressiva · progressive myositis ossificans · progressive ossifying myositis

Data availability: 31 cell lines.

Disease family

This is a subtype of myositis disease. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.

Classification path: disease › human disease › disease by body system or component › musculoskeletal system disorder › muscle tissue disorder › skeletal muscle disorder › myopathy › myositis disease › myositis ossificans

Related subtypes (10): idiopathic granulomatous myositis, tendinitis, myositis fibrosa, inclusion body myositis, viral myositis, bacterial myositis, fungal myositis, infectious myositis, orbital myositis, idiopathic inflammatory myopathy

Subtypes (1): traumatic myositis ossificans

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

Drugs indicated for this disease

1 approved, 1 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.

Drug	Development status
Palovarotene	Approved (phase 4)
Garetosmab	Phase 3 (in late-stage trials)

Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Saracatinib.

Clinical trials & evidence

Clinical trials

Clinical trials: 23.

Phase distribution (across all retrieved trials)

Phase	Trials
Not specified	8
PHASE2	7
PHASE3	4
PHASE1	3
PHASE2/PHASE3	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)
NCT06508021	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	A Study of Andecaliximab in 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)
NCT03312634	PHASE3	COMPLETED	An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.
NCT05027802	PHASE3	COMPLETED	A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.
NCT05090891	PHASE2	RECRUITING	To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
NCT02190747	PHASE2	COMPLETED	An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects
NCT02279095	PHASE2	COMPLETED	An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)
NCT02521792	PHASE2	TERMINATED	In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects
NCT03188666	PHASE2	COMPLETED	A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
NCT04307953	PHASE2	UNKNOWN	Saracatinib Trial TO Prevent FOP
NCT05039515	PHASE2	TERMINATED	A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).
NCT04818398	PHASE1	COMPLETED	Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects
NCT04829773	PHASE1	COMPLETED	Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects
NCT04829786	PHASE1	COMPLETED	Study to Compare the Pharmacokinetics, Safety, and Tolerability Following Administration of Palovarotene in Healthy Japanese and Non-Asian Subjects
NCT02745158	Not specified	RECRUITING	The Fibrodysplasia Ossificans Progressiva (FOP) Registry
NCT06089616	Not specified	RECRUITING	A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
NCT06724562	Not specified	RECRUITING	IL1 Inhibition in FOP
NCT02066324	Not specified	COMPLETED	Urine Sample Collection From FOP Patients
NCT02322255	Not specified	COMPLETED	A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP)
NCT04665323	Not specified	COMPLETED	An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.
NCT06064656	Not specified	COMPLETED	A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)
NCT07301450	Not specified	TEMPORARILY_NOT_AVAILABLE	An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
PALOVAROTENE	4	6
MIDAZOLAM	4	1
GARETOSMAB	3	4
ANDECALIXIMAB	3	1
FIDRISERTIB	2	1
PRAFNOSBART	2	1
ZILURGISERTIB	2	1
SARACATINIB DIFUMARATE	-1	1