COMPANY
Deciphera Pharmaceuticals, LLC
FDA-approved therapeutic company Clinical Phase 3
We produce limited quantities of drug substance for evaluation in our research programs. From public records Source · Feb 7, 2024
Timeline
- Trial start Phase 1: Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants source ↗
- FDA FDA New indication / efficacy supplement: ROMVIMZA (vimseltinib) — NDA219304/2, Jun 26, 2026. Applicant at approval: Deciphera Pharmaceuticals, LLC. source ↗
- Trial start Phase 1: Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) source ↗
- Trial start Phase 1: Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) source ↗
- Trial start Phase 1: Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate source ↗
- Trial start —: MOVE: Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib source ↗
- Trial start Phase 1: Study of DCC-2812 in Participants With Advanced Genitourinary Cancers source ↗
- FDA FDA New drug/biologic (novel): ROMVIMZA (vimseltinib) — NDA219304, Feb 14, 2025. Applicant at approval: Deciphera Pharmaceuticals, LLC. source ↗
- Trial start Phase 1/Phase 2: A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST) source ↗
- Trial start Phase 2: A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD) source ↗
- Trial start Phase 1: Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway source ↗
- Trial start Phase 3: A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib source ↗
- Trial start Phase 1/Phase 2: A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies source ↗
- Trial start Phase 1/Phase 2: Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST) source ↗
- Trial start Phase 3: Study of Vimseltinib for Tenosynovial Giant Cell Tumor source ↗
- Trial start Phase 1: A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients with Advanced GIST source ↗
- Trial start Phase 1: Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors source ↗
- Trial start Phase 3: A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib source ↗
- Trial start Phase 1/Phase 2: A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors source ↗
- Trial start 1: A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors source ↗
- Trial start 3: Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies source ↗
- Trial start Phase 1/Phase 2: Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor source ↗
- Trial start Phase 1: A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies source ↗
- Trial start Phase 1: A Study of DCC-2701 in Participants With Advanced Solid Tumors source ↗
- Trial start Phase 1: Study Safety and Preliminary Efficacy of DCC-2036 in Patients With Leukemias (Ph+ CML With T315I Mutation) source ↗
Upcoming milestones
- 2026-10 (ESTIMATED) · Phase 1 · Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) · NCT07539090
- 2026-12 (ESTIMATED) · Phase 1 · Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants · NCT07744802
- 2027-03 (ESTIMATED) · Phase 1/Phase 2 · A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies · NCT05957367
- 2027-09 (ESTIMATED) · · MOVE: Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib · NCT07075471
- 2027-12 (ESTIMATED) · Phase 3 · A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib · NCT05734105
- 2028-05 (ESTIMATED) · Phase 1/Phase 2 · A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST) · NCT06630234
- 2028-08 (ESTIMATED) · Phase 1/Phase 2 · Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor · NCT03069469
- 2029-02 (ESTIMATED) · Phase 1 · Study of DCC-2812 in Participants With Advanced Genitourinary Cancers · NCT06966024
Clinical trials (lead sponsor) 24
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07744802 | Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants | Phase 1 | Recruiting | 2026-09 | 2026-12 (estimated) |
| NCT07539090 | Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) | Phase 1 | Recruiting | Jun 5, 2026 | 2026-10 (estimated) |
| NCT06966024 | Study of DCC-2812 in Participants With Advanced Genitourinary Cancers | Phase 1 | Recruiting | Aug 27, 2025 | 2029-02 (estimated) |
| NCT07075471 | MOVE: Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib | Not listed | Recruiting | Sep 3, 2025 | 2027-09 (estimated) |
| NCT05957367 | A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies | Phase 1/Phase 2 | Recruiting | Sep 28, 2023 | 2027-03 (estimated) |
| NCT03069469 | Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor | Phase 1/Phase 2 | Active, not recruiting | Feb 16, 2017 | 2028-08 (estimated) |
| NCT04892017 | Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors | Phase 1 | Terminated | Jun 15, 2021 | Mar 30, 2026 (actual) |
| NCT05059262 | Study of Vimseltinib for Tenosynovial Giant Cell Tumor | Phase 3 | Active, not recruiting | Oct 14, 2021 | Aug 10, 2023 (actual) |
| NCT06287463 | Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway | Phase 1 | Terminated | May 14, 2024 | Feb 13, 2026 (actual) |
| NCT07158411 | Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) | Phase 1 | Completed | Nov 20, 2025 | Jan 30, 2026 (actual) |
| NCT03673501 | A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib | Phase 3 | Active, not recruiting | Feb 8, 2019 | Sep 1, 2021 (actual) |
| NCT06630234 | A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST) | Phase 1/Phase 2 | Recruiting | Dec 10, 2024 | 2028-05 (estimated) |
| NCT07158398 | Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate | Phase 1 | Completed | Oct 31, 2025 | Dec 8, 2025 (actual) |
| NCT05734105 | A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib | Phase 3 | Active, not recruiting | Dec 13, 2023 | 2027-12 (estimated) |
| NCT06619561 | A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD) | Phase 2 | Recruiting | Nov 21, 2024 | 2029-10 (estimated) |
| NCT03717415 | A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors | Phase 1/Phase 2 | Terminated | Jan 2, 2019 | May 1, 2022 (actual) |
| NCT03601897 | A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors | 1 | Terminated | Oct 25, 2018 | May 23, 2022 (actual) |
| NCT04530981 | A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients with Advanced GIST | Phase 1 | Completed | Sep 22, 2021 | Nov 16, 2023 (actual) |
| NCT02571036 | A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies | Phase 1 | Completed | 2015-11 | Apr 29, 2022 (actual) |
| NCT03353753 | Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies | 3 | Completed | Feb 27, 2018 | May 31, 2019 (actual) |
| NCT05080621 | Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST) | Phase 1/Phase 2 | Withdrawn | 2021-11 | 2025-11 (estimated) |
| NCT04148092 | Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST | Not listed | Approved for marketing | Not listed | Not listed |
| NCT02228811 | A Study of DCC-2701 in Participants With Advanced Solid Tumors | Phase 1 | Terminated | 2014-06 | 2017-11 (actual) |
| NCT00827138 | Study Safety and Preliminary Efficacy of DCC-2036 in Patients With Leukemias (Ph+ CML With T315I Mutation) | Phase 1 | Completed | 2009-03 | 2013-01 (actual) |
FDA records (last 2 years)
- FDA New indication / efficacy supplement: ROMVIMZA (vimseltinib) — NDA219304/2, Jun 26, 2026. Applicant at approval: Deciphera Pharmaceuticals, LLC. source ↗
- FDA New drug/biologic (novel): ROMVIMZA (vimseltinib) — NDA219304, Feb 14, 2025. Applicant at approval: Deciphera Pharmaceuticals, LLC. source ↗
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