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Incyte

incyte.com ↗ · Mid-Atlantic

FDA-approved therapeutic company Clinical Phase 3

Keywords: oncology dermatology hematology neoplasms graft-versus-host disease Hidradenitis Suppurativa Chronic Graft-versus-host-disease NonSegmental Vitiligo Ovarian Cancer Myeloproliferative Neoplasms CRC (Colorectal Cancer) Unresectable Cholangiocarcinoma Hematologic Malignancies Essential Thrombocythemia Advanced/Metastatic Cholangiocarcinoma cGVHD Renal Insufficiency Kidney Diseases Anemia Post-essential Thrombocythemia Myelofibrosis Post-polycythemia Vera Myelofibrosis Hepatic Insufficiency Liver Diseases Head and Neck Cancer Squamous Cell Carcinoma of the Anal Canal Immune Thrombocytopenia Follicular Lymphoma Marginal Zone Lymphoma Atopic Dermatitis Cutaneous Squamous Cell Carcinoma Pancreatic Cancer Colorectal Cancer Breast Cancer Lung Cancer Melanoma Prurigo Metastatic Cholangiocarcinoma Chronic Graft Vs. Host Disease povorcitinib INCA034176 INCB123667 INCA33890 INCB161734

Profile checked Oct 10, 2026

288Trials (company is sponsor)8FDA records (2 yrs)

Timeline

  1. Trial start Phase 2: A Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at source ↗
  2. Trial start 3: Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E1 source ↗
  3. Trial start Phase 1: A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Impaired Renal Function and Participants on Hemodialysis source ↗
  4. Trial start Phase 2: A Study to Evaluate INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy source ↗
  5. Trial start Phase 1: A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment source ↗
  6. FDA FDA New drug/biologic (novel): ATEBRIOZ (zilurgisertib) — NDA221198, Sep 25, 2026. Applicant at approval: Incyte Corporation. source ↗
  7. Trial start Phase 1: A Study to Assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB161734 in Healthy Male Participants source ↗
  8. Trial start 3: A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia source ↗
  9. Trial start Phase 2: A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) source ↗
  10. FDA FDA New indication / efficacy supplement: ZYNYZ (retifanlimab-dlwr) — BLA761334/9, May 18, 2026. Applicant at approval: Incyte Corporation. source ↗
  11. Trial start Phase 1: A Study to Evaluate Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants source ↗
  12. Trial start Phase 1: Study of INCA036978 in Participants With Myeloproliferative Neoplasms source ↗
  13. FDA FDA Original approval: JAKAFI XR (ruxolitinib phosphate) — NDA217180, May 1, 2026. Applicant at approval: Incyte Corporation. source ↗
  14. Trial start Phase 3: A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma source ↗
  15. FDA FDA New indication / efficacy supplement: ZYNYZ (retifanlimab-dlwr) — BLA761334/8, Mar 30, 2026. Applicant at approval: Incyte Corporation. source ↗
  16. Trial start Phase 3: A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorect source ↗
  17. Trial start Phase 2: Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa source ↗
  18. Trial start Phase 1: A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies source ↗
  19. Trial start Phase 2: Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders source ↗
  20. FDA FDA New indication / efficacy supplement: ZYNYZ (retifanlimab-dlwr) — BLA761334/5, Dec 17, 2025. Applicant at approval: Incyte Corporation. source ↗
  21. Trial start Phase 3: Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression source ↗
  22. Trial start Phase 3: A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo source ↗
  23. Trial start Phase 2: A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression source ↗
  24. Trial start Phase 1: Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa source ↗
  25. Trial start Phase 1: A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms source ↗

Showing 25 of 57 dated events.

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) Showing 50 of 288

RecordTitlePhaseStatusStartPrimary completion
NCT06855498Rollover Study for Participants Previously Enrolled in Clinical Trials of PovorcitinibPhase 3RecruitingFeb 28, 2025Feb 28, 2028 (estimated)
NCT07049575Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis SuppurativaPhase 1RecruitingNov 3, 2025Dec 9, 2026 (estimated)
NCT07124078A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)Phase 2RecruitingMay 20, 2026Jan 31, 2029 (estimated)
NCT06804811A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental VitiligoPhase 3RecruitingNov 13, 2025Apr 30, 2027 (estimated)
NCT07214779Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 OverexpressionPhase 3RecruitingDec 9, 2025Nov 15, 2028 (estimated)
NCT06585774A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host DiseasePhase 3RecruitingJan 21, 2025Sep 28, 2027 (estimated)
NCT07441694Study of INCA036978 in Participants With Myeloproliferative NeoplasmsPhase 1RecruitingMay 11, 2026May 24, 2030 (estimated)
NCT07195916A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological MalignanciesPhase 1RecruitingJan 8, 2026Aug 18, 2028 (estimated)
NCT07588139A Study to Evaluate Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult ParticipantsPhase 1CompletedMay 18, 2026Sep 8, 2026 (actual)
NCT07284849A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal CancerPhase 3RecruitingMar 5, 2026Dec 29, 2028 (estimated)
NCT07213973Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis SuppurativaPhase 2RecruitingFeb 2, 2026Mar 25, 2028 (estimated)
NCT07623200A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia3RecruitingSep 8, 2026Jun 15, 2029 (estimated)
NCT07522073A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal AdenocarcinomaPhase 3RecruitingApr 9, 2026Sep 15, 2028 (estimated)
NCT07862998A Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic TherapyPhase 2Not yet recruitingDec 15, 2026Feb 25, 2031 (estimated)
NCT05919511Observational Study for Patients at Risk for Chronic Graft-Versus-Host DiseaseNot listedRecruitingAug 1, 2023Oct 15, 2027 (estimated)
NCT07797283Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E13Not yet recruitingDec 1, 2026May 1, 2032 (estimated)
NCT07854249A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Impaired Renal Function and Participants on HemodialysisPhase 1Not yet recruitingOct 26, 2026Mar 30, 2027 (estimated)
NCT04455841INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative DisordersPhase 1/Phase 2CompletedMar 19, 2021Apr 1, 2025 (actual)
NCT07853040A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic ImpairmentPhase 1Not yet recruitingOct 13, 2026Mar 31, 2027 (estimated)
NCT03358472Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)Phase 3CompletedDec 1, 2017Jul 19, 2018 (actual)
NCT04472429Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).Phase 3CompletedNov 9, 2020Apr 15, 2024 (actual)
NCT07823322A Study to Evaluate INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and ChemotherapyPhase 2Not yet recruitingOct 26, 2026May 14, 2029 (estimated)
NCT07814404A Study to Assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB161734 in Healthy Male ParticipantsPhase 1Not yet recruitingSep 18, 2026Oct 15, 2026 (estimated)
NCT07023627A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 OverexpressionPhase 2RecruitingNov 12, 2025Apr 27, 2027 (estimated)
NCT06548360A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental VitiligoPhase 3RecruitingJan 24, 2025Jun 5, 2028 (estimated)
NCT07104565Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell DisordersPhase 2RecruitingDec 29, 2025Sep 23, 2027 (estimated)
NCT06039384A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C MutationPhase 1TerminatedDec 28, 2023Apr 11, 2025 (actual)
NCT04680052A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.3Active, not recruitingApr 15, 2021Feb 23, 2024 (actual)
NCT06873789A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid TumorsPhase 1/Phase 2TerminatedJun 30, 2025Jul 29, 2026 (actual)
NCT05879822A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor NaivePhase 2Active, not recruitingOct 30, 2023Sep 30, 2026 (estimated)
NCT06818812A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D MutationPhase 1Active, not recruitingMar 27, 2025Mar 27, 2027 (estimated)
NCT06821542A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic TherapyPhase 3Active, not recruitingJun 4, 2025May 31, 2028 (estimated)
NCT06212999A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis SuppurativaPhase 3Active, not recruitingJan 30, 2024Dec 26, 2026 (estimated)
NCT06113445A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)Phase 3Active, not recruitingNov 29, 2023Feb 24, 2026 (actual)
NCT06832618A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic DermatitisPhase 3Active, not recruitingJun 17, 2025Aug 7, 2026 (actual)
NCT05888844A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell CarcinomaPhase 2Active, not recruitingOct 9, 2023Sep 28, 2026 (estimated)
NCT02955940An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of RuxolitinibPhase 2Active, not recruitingNov 30, 2016Sep 30, 2027 (estimated)
NCT04370704Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced MalignanciesPhase 1/Phase 2CompletedJul 27, 2020Aug 25, 2025 (actual)
NCT05755438A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)Phase 3CompletedMar 10, 2023Oct 7, 2024 (actual)
NCT06313593A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative NeoplasmsPhase 1Active, not recruitingAug 8, 2024Oct 9, 2028 (estimated)
NCT03656536A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic CholangiocarcinomaPhase 3TerminatedJun 3, 2019Jul 7, 2025 (actual)
NCT06843408A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHDPhase 1/Phase 2Active, not recruitingJun 25, 2025Jan 6, 2027 (estimated)
NCT05936359A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative NeoplasmsPhase 1Active, not recruitingSep 25, 2023Feb 29, 2028 (estimated)
NCT07008118A Study to Evaluate INCA035784 in Participants With Myeloproliferative NeoplasmsPhase 1RecruitingOct 1, 2025Mar 14, 2028 (estimated)
NCT06959225Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)Phase 3Active, not recruitingJun 23, 2025Oct 9, 2026 (estimated)
NCT05836324A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsPhase 1RecruitingJul 24, 2023May 3, 2029 (estimated)
NCT06179160A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D MutationPhase 1RecruitingJan 4, 2024Jan 1, 2027 (estimated)
NCT05238922Study of INCB123667 in Subjects With Advanced Solid TumorsPhase 1Active, not recruitingJul 5, 2022Jul 27, 2027 (estimated)
NCT05544032Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (GVHD)Not listedApproved for marketingNot listedNot listed
NCT06958211Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)Phase 3Active, not recruitingJun 12, 2025Oct 9, 2026 (estimated)

FDA records (last 2 years)

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