Last reviewed 2026-05-23 · How we verify

PDR001, Imatinib

Asan Medical Center · Phase 1 active Small molecule ✓ Verified May 2026

PDR001, Imatinib is a Small molecule drug developed by Asan Medical Center. It is currently in Phase 1 development.

PDR001 is a small molecule that, when combined with Imatinib, is being studied as a treatment for metastatic or unresectable Gastrointestinal Stromal Tumors (GIST) that have failed previous treatments. Imatinib is a known treatment for GIST, and PDR001 is being investigated as a potential additional therapy in combination with Imatinib.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	PDR001, Imatinib
Sponsor	Asan Medical Center
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

PDR001 Plus Imatinib for Metastatic or Unresectable GIST (PHASE1, PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

PDR001, Imatinib CI brief — competitive landscape report
PDR001, Imatinib updates RSS · CI watch RSS
Asan Medical Center portfolio CI

Frequently asked questions about PDR001, Imatinib

What is PDR001, Imatinib?

PDR001, Imatinib is a Small molecule drug developed by Asan Medical Center.

Who makes PDR001, Imatinib?

PDR001, Imatinib is developed by Asan Medical Center (see full Asan Medical Center pipeline at /company/asan-medical-center).

What development phase is PDR001, Imatinib in?

PDR001, Imatinib is in Phase 1.

Manufacturer: Asan Medical Center — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing