Last reviewed 2026-04-19 · How we verify

IPI-926 plus gemcitabine

Infinity Pharmaceuticals, Inc. · Phase 1 active Small molecule

IPI-926 plus gemcitabine is a Small molecule drug developed by Infinity Pharmaceuticals, Inc.. It is currently in Phase 1 development. Also known as: IPI-926, Hedgehog pathway inhibitor, Hedgehog.

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	IPI-926 plus gemcitabine
Also known as	IPI-926, Hedgehog pathway inhibitor, Hedgehog
Sponsor	Infinity Pharmaceuticals, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer (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:

IPI-926 plus gemcitabine CI brief — competitive landscape report
IPI-926 plus gemcitabine updates RSS · CI watch RSS
Infinity Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about IPI-926 plus gemcitabine

What is IPI-926 plus gemcitabine?

IPI-926 plus gemcitabine is a Small molecule drug developed by Infinity Pharmaceuticals, Inc..

Who makes IPI-926 plus gemcitabine?

IPI-926 plus gemcitabine is developed by Infinity Pharmaceuticals, Inc. (see full Infinity Pharmaceuticals, Inc. pipeline at /company/infinity-pharmaceuticals-inc).

Is IPI-926 plus gemcitabine also known as anything else?

IPI-926 plus gemcitabine is also known as IPI-926, Hedgehog pathway inhibitor, Hedgehog.

What development phase is IPI-926 plus gemcitabine in?

IPI-926 plus gemcitabine is in Phase 1.

Manufacturer: Infinity Pharmaceuticals, Inc. — full pipeline
Also known as: IPI-926, Hedgehog pathway inhibitor, Hedgehog

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