# ATEBRIOZ (zilurgisertib) by Mirum Pharmaceuticals Inc.: new human prescription drug listing

**Launch Signal Score:** 70/100

| Field | Value |
|---|---|
| Product | ATEBRIOZ |
| Generic name | zilurgisertib |
| NDC | 79378-029 |
| Labeler | Mirum Pharmaceuticals Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | NDA |
| Application number | NDA221198 |
| Dosage form | TABLET, FILM COATED |
| Route | ORAL |
| Active ingredients | ZILURGISERTIB FUMARATE 25 mg/1 |
| Marketing start | 2026-09-25 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=79378-029). Last refreshed: 2026-11-03T18:09:00.764Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.