DCC-2618

Deciphera Pharmaceuticals, LLC · Phase 3 active Small molecule

DCC-2618 is a Tyrosine kinase inhibitor Small molecule drug developed by Deciphera Pharmaceuticals, LLC. It is currently in Phase 3 development for Gastrointestinal stromal tumor (GIST), including imatinib-resistant and sunitinib-resistant disease, Advanced systemic mastocytosis. Also known as: ripretinib, Ripretinib.

DCC-2618 is a tyrosine kinase inhibitor that targets KIT, PDGFRA, and other receptor tyrosine kinases involved in gastrointestinal stromal tumors and other malignancies.

DCC-2618 is a tyrosine kinase inhibitor that targets KIT, PDGFRA, and other receptor tyrosine kinases involved in gastrointestinal stromal tumors and other malignancies. Used for Gastrointestinal stromal tumor (GIST), including imatinib-resistant and sunitinib-resistant disease, Advanced systemic mastocytosis.

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	DCC-2618
Also known as	ripretinib, Ripretinib
Sponsor	Deciphera Pharmaceuticals, LLC
Drug class	Tyrosine kinase inhibitor
Target	KIT, PDGFRA
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

DCC-2618 selectively inhibits multiple tyrosine kinases including KIT and PDGFRA, which are frequently mutated in gastrointestinal stromal tumors (GIST). By blocking these kinases, the drug prevents aberrant signaling that drives tumor cell proliferation and survival. It is designed to overcome resistance mechanisms that develop with earlier-generation KIT inhibitors.

Approved indications

• Gastrointestinal stromal tumor (GIST), including imatinib-resistant and sunitinib-resistant disease
• Advanced systemic mastocytosis

Common side effects

• Diarrhea
• Nausea
• Fatigue
• Vomiting
• Abdominal pain
• Anemia

Key clinical trials

• A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies (PHASE1, PHASE2)
• A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (PHASE3)
• A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib (PHASE3)
• A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST) (PHASE2)
• A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib (PHASE2)
• A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies (PHASE1)
• Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies (PHASE3)
• Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (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:

• DCC-2618 CI brief — competitive landscape report
• DCC-2618 updates RSS · CI watch RSS
• Deciphera Pharmaceuticals, LLC portfolio CI

Frequently asked questions about DCC-2618

What is DCC-2618?

DCC-2618 is a Tyrosine kinase inhibitor drug developed by Deciphera Pharmaceuticals, LLC, indicated for Gastrointestinal stromal tumor (GIST), including imatinib-resistant and sunitinib-resistant disease, Advanced systemic mastocytosis.

How does DCC-2618 work?

DCC-2618 is a tyrosine kinase inhibitor that targets KIT, PDGFRA, and other receptor tyrosine kinases involved in gastrointestinal stromal tumors and other malignancies.

What is DCC-2618 used for?

DCC-2618 is indicated for Gastrointestinal stromal tumor (GIST), including imatinib-resistant and sunitinib-resistant disease, Advanced systemic mastocytosis.

Who makes DCC-2618?

DCC-2618 is developed by Deciphera Pharmaceuticals, LLC (see full Deciphera Pharmaceuticals, LLC pipeline at /company/deciphera-pharmaceuticals-llc).

Is DCC-2618 also known as anything else?

DCC-2618 is also known as ripretinib, Ripretinib.

What drug class is DCC-2618 in?

DCC-2618 belongs to the Tyrosine kinase inhibitor class. See all Tyrosine kinase inhibitor drugs at /class/tyrosine-kinase-inhibitor.

What development phase is DCC-2618 in?

DCC-2618 is in Phase 3.

What are the side effects of DCC-2618?

Common side effects of DCC-2618 include Diarrhea, Nausea, Fatigue, Vomiting, Abdominal pain, Anemia.

What does DCC-2618 target?

DCC-2618 targets KIT, PDGFRA and is a Tyrosine kinase inhibitor.

Related

• Drug class: All Tyrosine kinase inhibitor drugs
• Target: All drugs targeting KIT, PDGFRA
• Manufacturer: Deciphera Pharmaceuticals, LLC — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Gastrointestinal stromal tumor (GIST), including imatinib-resistant and sunitinib-resistant disease
• Indication: Drugs for Advanced systemic mastocytosis
• Also known as: ripretinib, Ripretinib