Last reviewed 2026-06-02 · How we verify

CGT9486 plus sunitinib

Cogent Biosciences, Inc. · Phase 3 active Small molecule Under review

CGT9486 plus sunitinib is a FLT3 inhibitor; multi-targeted tyrosine kinase inhibitor Small molecule drug developed by Cogent Biosciences, Inc.. It is currently in Phase 3 development for Acute myeloid leukemia with FLT3 mutations.

CGT9486 is a selective FLT3 inhibitor combined with sunitinib, a multi-targeted tyrosine kinase inhibitor, to block FLT3 and PDGFR signaling in acute myeloid leukemia.

CGT9486 is a small molecule being studied in combination with sunitinib for the treatment of gastrointestinal stromal tumors and metastatic cancer. The study, NCT02401815, is a Phase 1b and 2a trial assessing the safety and pharmacokinetics of CGT9486 as a single agent and in combination with sunitinib.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	CGT9486 plus sunitinib
Sponsor	Cogent Biosciences, Inc.
Drug class	FLT3 inhibitor; multi-targeted tyrosine kinase inhibitor
Target	FLT3; PDGFR; KIT; VEGFR
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

CGT9486 selectively inhibits FLT3 (Fms-like tyrosine kinase 3), a key driver mutation in acute myeloid leukemia, while sunitinib provides broader tyrosine kinase inhibition targeting PDGFR, KIT, and other kinases. The combination aims to overcome resistance mechanisms and improve efficacy in FLT3-mutant AML.

Approved indications

Acute myeloid leukemia with FLT3 mutations

Common side effects

Myelosuppression
Gastrointestinal toxicity
Fatigue
Hemorrhage
Fluid retention

Key clinical trials

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:

CGT9486 plus sunitinib CI brief — competitive landscape report
CGT9486 plus sunitinib updates RSS · CI watch RSS
Cogent Biosciences, Inc. portfolio CI

Frequently asked questions about CGT9486 plus sunitinib

What is CGT9486 plus sunitinib?

CGT9486 plus sunitinib is a FLT3 inhibitor; multi-targeted tyrosine kinase inhibitor drug developed by Cogent Biosciences, Inc., indicated for Acute myeloid leukemia with FLT3 mutations.

How does CGT9486 plus sunitinib work?

CGT9486 is a selective FLT3 inhibitor combined with sunitinib, a multi-targeted tyrosine kinase inhibitor, to block FLT3 and PDGFR signaling in acute myeloid leukemia.

What is CGT9486 plus sunitinib used for?

CGT9486 plus sunitinib is indicated for Acute myeloid leukemia with FLT3 mutations.

Who makes CGT9486 plus sunitinib?

CGT9486 plus sunitinib is developed by Cogent Biosciences, Inc. (see full Cogent Biosciences, Inc. pipeline at /company/cogent-biosciences-inc).

What drug class is CGT9486 plus sunitinib in?

CGT9486 plus sunitinib belongs to the FLT3 inhibitor; multi-targeted tyrosine kinase inhibitor class. See all FLT3 inhibitor; multi-targeted tyrosine kinase inhibitor drugs at /class/flt3-inhibitor-multi-targeted-tyrosine-kinase-inhibitor.

What development phase is CGT9486 plus sunitinib in?

CGT9486 plus sunitinib is in Phase 3.

What are the side effects of CGT9486 plus sunitinib?

Common side effects of CGT9486 plus sunitinib include Myelosuppression, Gastrointestinal toxicity, Fatigue, Hemorrhage, Fluid retention.

What does CGT9486 plus sunitinib target?

CGT9486 plus sunitinib targets FLT3; PDGFR; KIT; VEGFR and is a FLT3 inhibitor; multi-targeted tyrosine kinase inhibitor.

Drug class: All FLT3 inhibitor; multi-targeted tyrosine kinase inhibitor drugs
Target: All drugs targeting FLT3; PDGFR; KIT; VEGFR
Manufacturer: Cogent Biosciences, Inc. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Acute myeloid leukemia with FLT3 mutations

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