FDA · United States
pralsetinib — FDA regulatory status
pralsetinib (GAVRETO) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- GAVRETO
- Originator
- RIGEL PHARMACEUTICALS INC
- Mechanism
- Coiled-coil domain-containing protein 6/Tyrosine-protein kinase receptor RET inhibitor
- Target
- Coiled-coil domain-containing protein 6/Tyrosine-protein kinase receptor RET
- Structured fields
- 8
Sponsor / originator context: RIGEL PHARMACEUTICALS INC. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Coiled-coil domain-containing protein 6/Tyrosine-protein kinase receptor RET inhibitor. Target: Coiled-coil domain-containing protein 6/Tyrosine-protein kinase receptor RET. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 1 published clinical program and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| GAVRETO ®(pralsetinib) capsules | Approved | RIGEL PHARMACEUTICALS | 2025-523158-15-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12043620 | Benzazole compounds and methods for making and using the compounds | US |
| 11963958 | RET inhibitor for use in treating cancer having a RET alteration | US |
| 11939317 | Amide compounds and method for making and using | US |
| 11827628 | Compositions and methods for inhibition of the JAK pathway | US |
| 11667611 | Compositions and methods for inhibition of the JAK pathway | US |
| 11530194 | Amide compounds and method for making and using | US |
| 11524955 | 2,4-diamino-pyrimidine compounds and method for making and using the compounds | US |
| 11370808 | Pyrazole compounds and methods for making and using the compounds | US |
| 11299486 | Benzazole compounds and methods for making and using the compounds | US |
| 11279686 | Nrf2 activating compounds and uses thereof | US |
| 11230554 | Methods of treating or preventing autoimmune diseases with 2,4-pyrimidinediamine compounds | US |
| 11220496 | Compounds and method for treating autoimmune diseases | US |
Related hubs
FAQ
What is the FDA approval status of pralsetinib?
pralsetinib currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get pralsetinib regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to pralsetinib?
This spoke lists 1 published program associated with pralsetinib in our pipeline index.