COMPANY
Taiho Oncology
FDA-approved therapeutic company Clinical Phase 3
Taiho Oncology is the US subsidiary of Japan's Taiho Pharmaceutical (part of Otsuka Holdings), headquartered in Princeton, NJ with a site in Pleasanton, CA, developing and commercializing cancer treatments for solid tumors and blood cancers. From company website Source · Oct 12, 2026
Timeline
- Trial start Phase 1: A Study of ARC-02 in B-cell NHL source ↗
- FDA FDA New indication / efficacy supplement: INQOVI (cedazuridine; decitabine) — NDA212576/8, May 13, 2026. Applicant at approval: Taiho Oncology, Inc. source ↗
- Trial start Phase 3: A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection source ↗
- Trial start Phase 2/Phase 3: Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. source ↗
- Trial start Phase 3: REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors) source ↗
- Trial start Phase 2: A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation. source ↗
- Trial start 2: Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors source ↗
- Trial start Phase 2: Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement source ↗
- Trial start Phase 1: A Study of TAS3351 in NSCLC Patients With EGFRmt source ↗
- Trial start Phase 1: A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) source ↗
- Trial start Phase 1: Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment source ↗
- Trial start Phase 1: Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment source ↗
- Trial start 1: Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer source ↗
- Trial start Phase 1: A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer source ↗
- Trial start Phase 1/Phase 2: Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) source ↗
- Trial start Phase 2: Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma source ↗
- Trial start Phase 3: Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements source ↗
- Trial start III: Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients source ↗
- Trial start Phase 1: A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer source ↗
- Trial start Phase 2: Futibatinib in Patients With Specific FGFR Aberrations source ↗
- Trial start Phase 2/Phase 3: A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) source ↗
- Trial start Phase 1: A Study of TAS1440 With ATRA in Subjects With r/r AML source ↗
- Trial start Phase 2: A Study of TAS-120 in Patients With Metastatic Breast Cancer source ↗
- Trial start Phase 2: A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose) source ↗
- Trial start Phase 1: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 source ↗
Upcoming milestones
- Oct 1, 2026 (ESTIMATED) · 2 · Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors · NCT05945823
- 2026-12 (ESTIMATED) · Phase 2 · Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement · NCT05727176
- 2026-12 (ESTIMATED) · Phase 1 · Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment · NCT04953897
- 2026-12 (ESTIMATED) · Phase 1 · Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment · NCT04953910
- 2027-04 (ESTIMATED) · Phase 2/Phase 3 · Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. · NCT06506955
- May 27, 2027 (ESTIMATED) · Phase 3 · REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors) · NCT05973773
- Nov 1, 2027 (ESTIMATED) · Phase 2/Phase 3 · A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) · NCT04256317
- Dec 31, 2027 (ESTIMATED) · Phase 2 · A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose) · NCT04093570
Clinical trials (lead sponsor) Showing 50 of 66
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT05403450 | A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) | Phase 1 | Terminated | Feb 22, 2023 | Dec 16, 2024 (actual) |
| NCT07691606 | A Study of ARC-02 in B-cell NHL | Phase 1 | Recruiting | Jun 22, 2026 | 2029-01 (estimated) |
| NCT04657081 | Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) | Phase 1/Phase 2 | Active, not recruiting | Feb 9, 2021 | Sep 30, 2024 (actual) |
| NCT04256317 | A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) | Phase 2/Phase 3 | Recruiting | May 21, 2020 | Nov 1, 2027 (estimated) |
| NCT05967689 | A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation. | Phase 2 | Recruiting | Jul 31, 2023 | Aug 31, 2028 (estimated) |
| NCT05727176 | Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement | Phase 2 | Recruiting | Jul 5, 2023 | 2026-12 (estimated) |
| NCT05945823 | Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors | 2 | Active, not recruiting | Jul 13, 2023 | Oct 1, 2026 (estimated) |
| NCT07128199 | A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection | Phase 3 | Active, not recruiting | Dec 22, 2025 | Oct 1, 2029 (estimated) |
| NCT05973773 | REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors) | Phase 3 | Active, not recruiting | Dec 18, 2023 | May 27, 2027 (estimated) |
| NCT04093570 | A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose) | Phase 2 | Enrolling by invitation | Sep 30, 2019 | Dec 31, 2027 (estimated) |
| NCT06506955 | Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. | Phase 2/Phase 3 | Active, not recruiting | Oct 1, 2024 | 2027-04 (estimated) |
| NCT07601399 | An EAP Treatment Protocol of Zipalertinib | Not listed | Available | Not listed | Not listed |
| NCT04953897 | Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment | Phase 1 | Recruiting | Dec 15, 2021 | 2026-12 (estimated) |
| NCT04953910 | Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment | Phase 1 | Recruiting | Dec 23, 2022 | 2026-12 (estimated) |
| NCT03502668 | Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS | 1 | Completed | Jul 27, 2018 | Jan 13, 2026 (actual) |
| NCT05765734 | A Study of TAS3351 in NSCLC Patients With EGFRmt | Phase 1 | Terminated | May 25, 2023 | Mar 14, 2025 (actual) |
| NCT02503423 | Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas | 1 | Active, not recruiting | Jul 14, 2015 | 2022-10 (actual) |
| NCT04507503 | Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements | Not listed | Approved for marketing | Not listed | Not listed |
| NCT04601857 | Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma | Phase 2 | Terminated | Jan 7, 2021 | Mar 8, 2024 (actual) |
| NCT04024436 | A Study of TAS-120 in Patients With Metastatic Breast Cancer | Phase 2 | Terminated | Jan 28, 2020 | May 31, 2023 (actual) |
| NCT04982926 | A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer | Phase 1 | Terminated | Sep 16, 2021 | Feb 26, 2025 (actual) |
| NCT04189445 | Futibatinib in Patients With Specific FGFR Aberrations | Phase 2 | Terminated | Aug 5, 2020 | Nov 11, 2024 (actual) |
| NCT03520075 | Study of ASTX029 in Subjects With Advanced Solid Tumors | Phase 1/Phase 2 | Completed | May 7, 2018 | Aug 1, 2024 (actual) |
| NCT03975387 | Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 | Phase 1 | Terminated | Jul 11, 2019 | Sep 11, 2023 (actual) |
| NCT02052778 | A Study of TAS-120 in Patients With Advanced Solid Tumors | Phase 1/Phase 2 | Completed | Jul 21, 2014 | Oct 1, 2020 (actual) |
| NCT04586270 | A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer | Phase 1 | Terminated | Oct 15, 2020 | Nov 14, 2024 (actual) |
| NCT04093362 | Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements | Phase 3 | Terminated | Jan 6, 2021 | Apr 22, 2024 (actual) |
| NCT04282668 | A Study of TAS1440 With ATRA in Subjects With r/r AML | Phase 1 | Terminated | Mar 15, 2020 | Feb 12, 2024 (actual) |
| NCT04737187 | Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients | III | Completed | Nov 25, 2020 | Jul 19, 2022 (actual) |
| NCT00667628 | Phase 2 Study of TAC-101 Combined With Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone in Japanese Patients With Advanced Hepatocellular Carcinoma | 2 | Terminated | Apr 24, 2008 | Dec 22, 2009 (actual) |
| NCT01285557 | Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial | Phase 3 | Terminated | Apr 14, 2011 | Aug 15, 2014 (actual) |
| NCT02855125 | A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1 | 2 | Completed | Aug 29, 2016 | Sep 30, 2017 (actual) |
| NCT01607957 | Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies | Phase 3 | Completed | Jun 17, 2012 | Jan 31, 2014 (actual) |
| NCT04965818 | Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer | 1 | Terminated | Sep 20, 2021 | Jun 11, 2023 (actual) |
| NCT00687596 | Study of TAC-101 as Second Line Treatment in Patients With Advanced Hepatocellular Carcinoma Who Received Sorafenib as First Line Therapy | Phase 2 | Terminated | Aug 1, 2008 | May 10, 2010 (actual) |
| NCT00651742 | Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer | 2 | Completed | Jan 9, 2006 | Jul 8, 2008 (actual) |
| NCT00400179 | A Safety and Efficacy Study in Patients With Gastric Cancer | Phase 3 | Completed | 2005-05 | 2008-03 (actual) |
| NCT02286492 | Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer | Not listed | Approved for marketing | Not listed | Not listed |
| NCT02031055 | Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors | Phase 1 | Completed | 2014-02 | 2014-11 (actual) |
| NCT03410927 | A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities | Phase 1 | Terminated | Apr 6, 2018 | Jun 9, 2022 (actual) |
| NCT02025803 | A Safety, Tolerability and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors | Phase 1 | Completed | 2012-11 | Jul 7, 2017 (actual) |
| NCT02301104 | A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment | I | Completed | 2015-01 | 2016-06 (actual) |
| NCT01867879 | Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors | Phase 1 | Completed | 2013-06 | 2014-08 (actual) |
| NCT01867866 | Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone | Phase 1 | Completed | 2013-05 | 2013-10 (actual) |
| NCT01904253 | A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy | 2 | Terminated | 2013-07 | 2014-06 (actual) |
| NCT01916447 | A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors. | I | Completed | 2013-09 | 2017-09 (actual) |
| NCT02978235 | A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma | Phase 1 | Terminated | Mar 1, 2017 | Feb 1, 2018 (actual) |
| NCT02301117 | A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment | I | Completed | 2015-01 | Jun 19, 2019 (actual) |
| NCT02134067 | Dose-escalating, Safety, Tolerability and PK Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors | Phase 1 | Terminated | 2014-08 | 2018-07 (actual) |
| NCT00398307 | Evaluating Patients With Varying Degrees of Renal Function | Phase 1 | Completed | 2006-02 | 2010-09 (actual) |
FDA records (last 2 years)
- FDA New indication / efficacy supplement: INQOVI (cedazuridine; decitabine) — NDA212576/8, May 13, 2026. Applicant at approval: Taiho Oncology, Inc. source ↗