Pralsetinib - Blueprint Medicines
Alternative Names: BLU-667; CS 3009; GAVRETO; Gavreto; Phukiva®; Pratinib; Pujihua; RG 6396Latest Information Update: 15 Apr 2026
At a glance
- Originator Blueprint Medicines
- Developer Blueprint Medicines; CStone Pharmaceuticals; Rigel Pharmaceuticals; Roche
- Class Amides; Amines; Antineoplastics; Cyclohexanes; Ethers; Fluorinated hydrocarbons; Pyrazoles; Pyridines; Pyrimidines; Small molecules
- Mechanism of Action Proto-oncogene protein c-ret inhibitors
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Orphan Drug Status
Yes - Thyroid cancer; Non-small cell lung cancer
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Non-small cell lung cancer; Thyroid cancer
- Phase III Solid tumours
Most Recent Events
- 31 Mar 2026 Adverse events and efficacy data from the phase I/II ARROW trial in Solid tumours released by Rigel Pharmaceuticals
- 12 Jan 2026 Pralsetinib has a boxed warning of for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death
- 25 Nov 2025 Phase-III clinical trials in Solid tumours (Metastatic disease, Late-stage disease) in Spain (PO) (CTIS2025-523158-15-00)