Wednesday, July 8, 2026

Drug profile · INN

pralsetinib

pralsetinib (GAVRETO) is a coiled-coil domain-containing protein 6/tyrosine-protein kinase receptor ret inhibitor. Associated with RIGEL PHARMACEUTICALS INC. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: withdrawn Antineoplastic and immunomodulating agents (L01) L01EX23
US status approved
Patents linked 20
Pipeline programs 1
News articles 0
Drug details — pralsetinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
20
Programs
1
Data quality
0.89

Quick answer

pralsetinib (GAVRETO) is a coiled-coil domain-containing protein 6/tyrosine-protein kinase receptor ret inhibitor. Associated with RIGEL PHARMACEUTICALS INC. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN pralsetinib
Brand GAVRETO
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
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01EX23

Mechanism of action

Coiled-coil domain-containing protein 6/Tyrosine-protein kinase receptor RET inhibitor

Primary target: Coiled-coil domain-containing protein 6/Tyrosine-protein kinase receptor RET

Approval history

Authority Status Date
FDA approved
EMA withdrawn

Pipeline programs

  1. GAVRETO ®(pralsetinib) capsules Approved · RIGEL PHARMACEUTICALS · Patients with advanced or metastatic solid tumors

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
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Frequently asked questions

What is pralsetinib?

pralsetinib (GAVRETO) is a coiled-coil domain-containing protein 6/tyrosine-protein kinase receptor ret inhibitor. Associated with RIGEL PHARMACEUTICALS INC. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for pralsetinib?

GAVRETO is a marketed brand name for pralsetinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of pralsetinib?

pralsetinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.