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FDA Medication Tracker

← All approvals · Rare & genetic · 2026

Pasatru (garetosmab-grts)

The FDA approved Pasatru (garetosmab-grts) on August 19, 2026 to reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva.
Brand name
Pasatru
Generic name
garetosmab-grts
FDA approval date
August 19, 2026
Approved use (FDA wording)
To reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva
Company
Regeneron Pharmaceuticals, Inc.
Application
BLA761508
Dosage form / route
INJECTABLE · INTRAVENOUS
Boxed warning on label
Not listed
Category on this site
Rare & genetic

Indications and usage, from the FDA label

PASATRU is indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). PASATRU is an activin signaling inhibitor indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.