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GIST

6
Pipeline Programs
8
Companies
11
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
2
0
2
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
9100%
+ 2 programs with unclassified modality

On Market (1)

Approved therapies currently available

Takeda
ICLUSIGApproved
ponatinib hydrochloride
Takeda
oral2012
123M Part D

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Takeda
TakedaTOKYO, Japan
1 program
1
ICLUSIG(Ponatinib)PHASE_2Small Molecule1 trial
Active Trials
NCT01874665Completed45Est. Jul 2016
Deciphera Pharmaceuticals
2 programs
1
1
RipretinibPhase 3Small Molecule1 trial
InlexisertibPhase 1/2Small Molecule1 trial
Active Trials
NCT05957367Recruiting94Est. Mar 2029
NCT05734105Active Not Recruiting54Est. Dec 2028
Ascentage Pharma
Ascentage PharmaChina - Beijing
1 program
1
OlverembatinibPhase 3Small Molecule1 trial
Active Trials
NCT06640361Recruiting40Est. Jun 2029
Sandoz
SandozAustria - Kundl
1 program
1
NilotinibPhase 2Small Molecule1 trial
Active Trials
NCT01089595Terminated5Est. Mar 2012
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
PazopanibPhase 2Small Molecule
Blueprint Medicines
Blueprint MedicinesMA - Cambridge
3 programs
AvapritinibN/ASmall Molecule1 trial
Patient treated by Avapritinib in real lifeN/A1 trial
avapritinibPHASE_3Small Molecule1 trial
Active Trials
NCT03862885Approved For Marketing
NCT04927260Unknown25Est. Dec 2024
NCT03465722Completed476Est. Sep 2021
Biogen
BiogenCAMBRIDGE, MA
1 program
BIIB021PHASE_22 trials
Active Trials
NCT00618319Completed20Est. Apr 2010
NCT00412412Completed34Est. Apr 2011
GSK
GSKLONDON, United Kingdom
1 program
PazopanibPHASE_2Small Molecule1 trial
Active Trials
NCT01323400Completed81Est. Feb 2016

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Ascentage PharmaOlverembatinib
Deciphera PharmaceuticalsRipretinib
Blueprint Medicinesavapritinib
TakedaPonatinib
GSKPazopanib
SandozNilotinib
BiogenBIIB021
Deciphera PharmaceuticalsInlexisertib
BiogenBIIB021
Blueprint MedicinesPatient treated by Avapritinib in real life

Clinical Trials (11)

Total enrollment: 874 patients across 11 trials

NCT06640361Ascentage PharmaOlverembatinib

A Study of Olverembatinib in SDH-deficient GIST.

Start: Nov 2024Est. completion: Jun 202940 patients
Phase 3Recruiting
NCT05734105Deciphera PharmaceuticalsRipretinib

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

Start: Dec 2023Est. completion: Dec 202854 patients
Phase 3Active Not Recruiting
NCT03465722Blueprint Medicinesavapritinib

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

Start: Mar 2018Est. completion: Sep 2021476 patients
Phase 3Completed
NCT01874665TakedaPonatinib

A Phase 2 Trial of Ponatinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor

Start: Jun 2013Est. completion: Jul 201645 patients
Phase 2Completed
NCT01323400GSKPazopanib

Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST)

Start: Mar 2011Est. completion: Feb 201681 patients
Phase 2Completed
NCT01089595SandozNilotinib

Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Start: Feb 2009Est. completion: Mar 20125 patients
Phase 2Terminated
NCT00618319BiogenBIIB021

An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)

Start: Feb 2008Est. completion: Apr 201020 patients
Phase 2Completed
NCT05957367Deciphera PharmaceuticalsInlexisertib

A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies

Start: Sep 2023Est. completion: Mar 202994 patients
Phase 1/2Recruiting
NCT00412412BiogenBIIB021

CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study

Start: Dec 2007Est. completion: Apr 201134 patients
Phase 1Completed
NCT03862885Blueprint MedicinesAvapritinib

Early Access Program (EAP) for Avapritinib in Patients With Locally Advanced Unresectable or Metastatic GIST

N/AApproved For Marketing
NCT04927260Blueprint MedicinesPatient treated by Avapritinib in real life

French Long Term Registry With Longitudinal Follow up of PDGFRA D842V-GIST Patients

Start: Mar 2021Est. completion: Dec 202425 patients
N/AUnknown

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
2 actively recruiting trials targeting 874 patients
Small Molecule is the dominant modality (100% of programs)
8 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.