Molecule
Garetosmab is a prescription medicine indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). It is available as injection for intravenous use. MedsAcross supplies Garetosmab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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).
Source: US FDA prescribing information
FOP is caused by gain-of-function mutations in the intracellular domain of activin receptor type 1 (ACVR1, also known as ALK2), a bone morphogenetic protein (BMP) type I receptor that is expressed in many tissues, including skeletal muscle and cartilage. In patients with FOP, mutant ACVR1 is activated by activin A resulting in heterotopic ossification. Garetosmab-grts is a human IgG4 monoclonal antibody that specifically binds to and inhibits signaling by activin A to block the activation of FOP-mutant ACVR1 and reduce the formation and progression of new heterotopic bone lesions.
Source: US FDA prescribing information
Recommended starting dosage: 10 mg/kg intravenous (IV) infusion over 60 minutes once every 4 weeks. May decrease dosage to 3 mg/kg IV infusion over 60 minutes once every 4 weeks if 10 mg/kg is not tolerated. See Full Prescribing Information for preparation and administration instructions.
Source: US FDA prescribing information
PASATRU is contraindicated during pregnancy. PASATRU can cause fetal harm when administered to a pregnant woman. Pregnancy.
Source: US FDA prescribing information
Embryo-Fetal Toxicity: PASATRU can cause fetal harm. Verify females of reproductive potential are not pregnant prior to initiating PASATRU and advise of the potential risk to a fetus and to use effective contraception. Advise the patient to discontinue PASATRU immediately if pregnancy occurs during treatment and to contact their healthcare provider. Skin and Soft Tissue Infections: Have occurred in patients treated with PASATRU. Advise patients to report signs or symptoms of infection to their healthcare provider. Epistaxis: Spontaneous epistaxis, including serious cases requiring medical intervention, has been reported in patients receiving PASATRU. Advise patients to seek medical attention if they experience epistaxis that is severe, prolonged and does not resolve with standard first-aid measures.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Skin and Soft Tissue Infections Epistaxis The most common adverse reactions (incidence ≥10%) are abscess, acne, increased hair growth, madarosis, oral ulcers, and epistaxis.
Source: US FDA prescribing information
Store the unopened vial in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Garetosmab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Pasatru 300 mg/5 mL injectionIntravenous Cold chain | Regeneron Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 19 August 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Garetosmab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Garetosmab, including Pasatru.
Yes. The US FDA first approved Garetosmab on 19 August 2026, according to Drugs@FDA.
At least one listed presentation of Garetosmab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.