Gavreto

(Pralsetinib)

ApprovedSmall molecule

Gavreto is a small molecule that works as a RET Inhibitor.[2] It is being used across 4 indications, with its most advanced program in Approved.[1]

Gavreto is one of 109 small molecule programs targeting NSCLC (Non-small Cell Lung Cancer). It is currently in Approved.

Indications

Total Trials

Active Trials

108

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

NSCLC (non-Small Cell Lung Cancer)Recruiting

Solid TumorActive, not recruiting

UnresectableRecruiting

Thyroid CancerNot yet recruiting

NSCLC (non-Small Cell Lung Cancer)Approved

Recruiting

Solid TumorPhase 2

Active, not recruiting

UnresectablePhase 2

Recruiting

Thyroid CancerApproved

Not yet recruiting

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

Gavreto

RRigel Pharmaceuticals

Approved

2 2

Fludara

Sanofi

Preclinical

1 3

DATROWAY

Daiichi Sankyo

Preclinical

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

2 5

Navmi

SSummit Therapeutics

Preclinical

1 6

Paxil

SSebela Pharmaceuticals Development LLC

Preclinical

1 7

Proleukin

IIovance Biotherapeutics, Inc.

Preclinical

1 8

Soc

Pfizer

Preclinical

1 9

Tulmimetostat

Novartis

Preclinical

1 10

Carboplatin AUC-5

Merck & Co.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Recruiting

Solid Tumor

NCT05525858

Q3 2027

ApprovedRecruiting

NSCLC (non-Small Cell Lung Cancer)

NCT07704658

Q4 2028

N/ANot yet recruiting

Real-World Study

NCT07418879

Post-ApprovalNot yet recruiting

Thyroid Cancer

NCT07010393

Q4 2029

Phase 2Recruiting

Unresectable

NCT06563999

Clinical

Trials by Indication[1]

Thyroid Cancer3 trials

Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

Recruiting·WWest China Hospital·Phase 2·NCT06482086·75 enrolled

A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).

Withdrawn· Roche logo

Roche·Phase 3·NCT04760288

Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

Not yet recruiting·FFujian Medical University·Phase 4·NCT07010393·335 enrolled

Non-Small Cell Lung Cancer3 trials

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

Completed· Roche logo

Roche·Phase 1/2·NCT03037385·590 enrolled

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Terminated· Roche logo

Roche·Phase 3·NCT04222972·223 enrolled

NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer

Recruiting· Roche logo

Roche·Phase 2·NCT04302025·99 enrolled

Solid Tumor2 trials

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04589845·920 enrolled

KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

Recruiting·SSeoul National University Bundang Hospital··NCT05525858·1,000 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Real-world Study1 trial

A Real-world Study of Pralsetinib Combined With Leucogen in the Treatment of RET Fusion-positive NSCLC

Not yet recruiting·FFudan University·N/A·NCT07418879·25 enrolled

4 more indications

Advanced Solid Tumors1 trial

A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

Completed· Roche logo

Roche·Phase 2·NCT04632992·252 enrolled

Metastatic NSCLC1 trial

Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC

Approved for marketing·BBlueprint Medicines··NCT04204928

Unresectable1 trial

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Recruiting·SSun Yat-sen University·Phase 2·NCT06563999·120 enrolled

NSCLC (Non-small Cell Lung Cancer)1 trial

A Multi-center, Open-label, Drug-drug Interaction Study to Evaluate the Effect of Pralsetinib (Gavreto) on the Pharmacokinetics of CYP3A4, CYP2C8, and CYP2C9 Substrates, and Hormones Estradiol/Norethisterone Acetate in Patients With Advanced or Metastatic Solid Tumors

Recruiting·RRigel Pharmaceuticals·Approved·NCT07704658·12 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 4, 2020

GAVRETO

NDA NDA213721

Sep 4, 2020

GAVRETO

NDA NDA213721

Nov 10, 2021

GAVRETO

NDA NDA213721

Feb 2, 2022

GAVRETO

NDA NDA213721

Sep 28, 2022

GAVRETO

NDA NDA213721

Jun 30, 2023

GAVRETO

NDA NDA213721

Jul 20, 2023

GAVRETO

NDA NDA213721

Aug 9, 2023

GAVRETO

NDA NDA213721

Mar 22, 2024

GAVRETO

NDA NDA213721

Dec 22, 2025

GAVRETO

NDA NDA213721

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Pralsetinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pralsetinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pralsetinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213721). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Gavreto. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Rigel Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: RET Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: RRigel Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Oct 31, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12655128Oct 31, 2036

10030005Nov 1, 2036

12539303Apr 3, 2039

11872192Apr 3, 2039

11963958Apr 3, 2039

3 more patents

11273160Apr 3, 2039

12448366Jul 7, 2042

12692251Apr 19, 2043

Gavreto

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q4 2028

Q4 2029

Trials by Indication[1]

Thyroid Cancer3 trials

Non-Small Cell Lung Cancer3 trials

Solid Tumor2 trials

Immunotherapy1 trial

Real-world Study1 trial

Advanced Solid Tumors1 trial

Metastatic NSCLC1 trial

Unresectable1 trial

NSCLC (Non-small Cell Lung Cancer)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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