Drug

Pralsetinib

Regulatory activity · EMA

ClassTyrosine-protein kinase receptor RET inhibitorEmerging researchLate-stage development

Also known as Gavreto.

RxNorm2394936 ChEMBLCHEMBL4582651 ATCL01EX23UNII1WPE73O1WV

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-07-09Results expected Q4 2026 · ClinicalTrials.gov

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

Clinical trial2026-05-08Results expected Q3 2032 · ClinicalTrials.gov

Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)

Clinical trial2026-04-21Results expected Q4 2027 · ClinicalTrials.gov

A Real-world Clinical Study of Pralsetinib in the Treatment of RET Fusion-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Prophylactic Use of Leukocyte-increasing Drug Leucogen

Clinical trial2026-02-18Results expected Q4 2027 · ClinicalTrials.gov

A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma

Clinical trial2025-06-08Results expected Q4 2027 · ClinicalTrials.gov

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

Clinical trial2025-05-31Results posted · ClinicalTrials.gov

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer

Clinical trial2025-01-27Terminated · ClinicalTrials.gov

MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

Clinical trial2025-01-08Results posted · ClinicalTrials.gov

Precision Medicine Applied to Locally Advanced Thyroid Cancer Using Tumor-derived Organoids and In-vitro Sensitivity Testing: a Phase 2a, Single-center, Open-label, and Non-comparative Study

Clinical trial2024-12-01Primary completion · ClinicalTrials.gov

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

Clinical trial2024-12-01Primary completion · ClinicalTrials.gov

Market withdrawal: Gavreto (EMA)

Regulatory2024-10-24EMA

Pralsetinib in Patients with Advanced/Metastatic Rearranged During Transfection (RET)-Altered Thyroid Cancer: Updated Efficacy and Safety Data from the ARROW Study.

Research2024-01-01Thyroid : official journal of the American Thyroid Association

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Pralsetinib

Aliases & brands

Gavreto

RxNorm CUI

2394936

ChEMBL ID

CHEMBL4582651

ATC codes

L01EX23

UNII

1WPE73O1WV

Primary mechanism

Tyrosine-protein kinase receptor RET inhibitor

Regulatory jurisdictions

ema

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Proto-oncogene tyrosine-protein kinase receptor Ret

RET · P07949

INHIBITORTyrosine-protein kinase receptor RET inhibitor

Coiled-coil domain-containing protein 6

CCDC6 · Q16204

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

Kinesin-1 heavy chain

KIF5B · P33176

INHIBITORKinesin-1 heavy chain/ Tyrosine-protein kinase receptor RET inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2024-10-24Market withdrawalMarket

Market withdrawal: Gavreto (EMA)

Indication: Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not… Show full indication

Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

11 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2024

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 11

Phase 1 / 21Phase 26Phase 32Phase 41Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma

Not yet recruitingPH IVFujian Medical Universityn=3352028

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer.

WithdrawnPH IIIHoffmann-La Roche2035

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer

TerminatedPH IIIHoffmann-La Rochen=2232025

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH I/IIHoffmann-La Rochen=5902024

MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

CompletedPH IIGenentech, Inc.n=2522024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Pralsetinib in Patients with Advanced/Metastatic Rearranged During Transfection (RET)-Altered Thyroid Cancer: Updated Efficacy and Safety Data from the ARROW Study.

Thyroid : official journal of the American Thyroid Association · 2024 · 40 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Cabozantinib

Studied across 2 of the same disease areas as Pralsetinib in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.