Medicine
Atebrioz 25 mg tablet
Atebrioz 25 mg tablet is a prescription medicine containing Zilurgisertib for oral use, marketed by Mirum Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store ATEBRIOZ tablets at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted…
Key facts
- Active ingredient (INN)
- Zilurgisertib
- Brand
- Atebrioz
- Strength
- 25 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 120 tablets
- Marketing authorisation holder
- Mirum Pharmaceuticals
- Manufacturer
- Mirum Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store ATEBRIOZ tablets at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (59ºF and 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 September 2026
- Identifiers
- RxCUI 2754652, 2754658DailyMed set ID f542e4b0-072a-42c6-80c9-5977054971e0NDC 79378-029Application NDA221198
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 120 tablet, film coated in 1 bottle, plastic | 79378-029-16 | Mirum Pharmaceuticals | 25 September 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 25 September 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 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Zilurgisertib is a prescription medicine indicated to reduce the volume of total new heterotopic ossification (HO) in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP). MedsAcross supplies Zilurgisertib 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
Read about ZilurgisertibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ATEBRIOZ prescribing information (Mirum Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Atebrioz 25 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.