Heterotopic ossification is abnormal formation of mature lamellar bone in soft tissues outside the normal skeleton. It commonly develops after trauma, orthopedic surgery, burns, or neurologic injury and can cause pain, swelling, and restricted joint motion. Disease severity varies from asymptomatic radiographic findings to severe functional limitation.
The FDA has accepted Regeneron's Biologics License Application for garetosmab to treat fibrodysplasia ossificans progressiva, granting Priority Review with a target action date of August 2026. The application is supported by Phase 3 OPTIMA trial data.
The FDA has accepted Regeneron's biologics license application for garetosmab with priority review, targeting fibrodysplasia ossificans progressiva. A decision is expected by August 2026 based on Phase 3 trial data showing significant reductions in new bone lesions.
The FDA has accepted for Priority Review Regeneron's biologics license application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target action date of August 2026.
The FDA has accepted for Priority Review the Biologics License Application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target decision date of August 2026. The application is supported by Phase 3 OPTIMA trial data showing significant reductions in heterotopic bone lesions.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06903299 |
Prospective Investigation of Intra-Articular Tranexamic Acid Use in Elective Hip Arthroplasty |
ACTIVE_NOT_RECRUITING | |
| NCT06251349 |
Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications |
COMPLETED | |
| NCT06088407 |
Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery |
COMPLETED | NA |
| NCT05648916 |
Celebrex and HO Study |
UNKNOWN | |
| NCT05218954 |
Balance in Patients With Ectopic Bone Tissue After Total Hip Replacement |
COMPLETED | |
| NCT04934332 |
Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma |
UNKNOWN | NA |
| NCT04867278 |
Heterotopic Ossification Prophylaxis |
COMPLETED | NA |
| NCT04867018 |
Defining the Pathophysiology of Heterotopic Ossification: A Prospective Study |
WITHDRAWN | |
| NCT03974698 |
Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach |
COMPLETED | NA |
| NCT03925688 |
Assessment of Heterotopic Ossification of Elbow Joint in Relation of Serum Uric Acid. |
COMPLETED |
