COMPANY
Daiichi Sankyo
FDA-approved therapeutic company Clinical Phase 3
Timeline
- Trial start Phase 3: A Study of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab as Maintenance Therapy in Second-Line Platinum-Sensitive Recurrent Ovarian Cancer (REJOICE-Ovarian03) source ↗
- Trial start Phase 1/Phase 2: A Study of DS-3939a in Participants With Solid Tumors source ↗
- Trial start Phase 3: A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events source ↗
- Trial start Phase 1/Phase 2: A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic B source ↗
- Trial start Phase 3: T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd source ↗
- Trial start Phase 1: First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors source ↗
- FDA FDA New indication / efficacy supplement: DATROWAY (datopotamab deruxtecan-dlnk) — BLA761394/3, May 22, 2026. Applicant at approval: Daiichi Sankyo, Inc. source ↗
- FDA FDA New indication / efficacy supplement: ENHERTU (fam-trastuzumab deruxtecan-nxki) — BLA761139/41, May 15, 2026. Applicant at approval: Daiichi Sankyo, Inc. source ↗
- FDA FDA New indication / efficacy supplement: ENHERTU (fam-trastuzumab deruxtecan-nxki) — BLA761139/43, May 15, 2026. Applicant at approval: Daiichi Sankyo, Inc. source ↗
- FDA FDA New indication / efficacy supplement: ENHERTU (fam-trastuzumab deruxtecan-nxki) — BLA761139/39, Apr 27, 2026. Applicant at approval: Daiichi Sankyo, Inc. source ↗
- Trial start —: A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia source ↗
- Trial start Phase 1/Phase 2: A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies source ↗
- FDA FDA New indication / efficacy supplement: ENHERTU (fam-trastuzumab deruxtecan-nxki) — BLA761139/38, Dec 15, 2025. Applicant at approval: Daiichi Sankyo, Inc. source ↗
- Trial start Phase 3: Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer source ↗
- Trial start Phase 1: A Study of DS3610a in Participants With Advanced Solid Tumor source ↗
- Trial start Phase 1: A Study of DS5361b in Participants With Advanced Solid Tumors source ↗
- Trial start Phase 3: Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer source ↗
- Trial start Phase 2/Phase 3: Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma source ↗
- Trial start Phase 2: Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission source ↗
- Trial start Phase 1: A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors source ↗
- Trial start Phase 3: A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01) source ↗
- Trial start Phase 3: Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01) source ↗
- Trial start —: Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China source ↗
- Trial start Phase 3: Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer source ↗
- Trial start —: Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN) source ↗
Upcoming milestones
- Oct 20, 2026 (ESTIMATED) · Phase 1/Phase 2 · First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors · NCT05875168
- Dec 30, 2026 (ESTIMATED) · Phase 1 · A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors · NCT04707248
- Jan 31, 2027 (ESTIMATED) · Phase 2 · Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy · NCT04433234
- Feb 12, 2027 (ESTIMATED) · · Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN) · NCT06809764
- Apr 30, 2027 (ESTIMATED) · Phase 1/Phase 2 · Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors · NCT04145622
- Jul 20, 2027 (ESTIMATED) · Phase 1/Phase 2 · A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03) · NCT06362252
- Jul 31, 2027 (ESTIMATED) · · Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China · NCT06846996
- Sep 1, 2027 (ESTIMATED) · Phase 2 · A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors · NCT06172478
Clinical trials (lead sponsor) Showing 50 of 393
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT05765851 | A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors | Phase 1 | Recruiting | May 30, 2023 | May 31, 2029 (estimated) |
| NCT07862465 | Medical Access Program for Valemetostat Tosylate (DS 3201b) For The Treatment of Patients With Relapsed/Refractory (R/R) Peripheral T-cell Lymphoma (PTCL) | Not listed | Temporarily not available | Not listed | Not listed |
| NCT07863284 | Medical Access Program for DS-9606a (DS-9606) in Patients With Advanced Testicular Germ Cell Tumors | Not listed | Temporarily not available | Not listed | Not listed |
| NCT03529110 | DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] | Phase 3 | Completed | Aug 9, 2018 | May 21, 2021 (actual) |
| NCT04458272 | A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma | Phase 2 | Active, not recruiting | Jul 8, 2020 | Mar 10, 2023 (actual) |
| NCT04145622 | Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors | Phase 1/Phase 2 | Active, not recruiting | Nov 3, 2019 | Apr 30, 2027 (estimated) |
| NCT07535359 | Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer | Not listed | No longer available | Not listed | Not listed |
| NCT04433234 | Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy | Phase 2 | Active, not recruiting | Jun 30, 2020 | Jan 31, 2027 (estimated) |
| NCT07701941 | A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer | Phase 1/Phase 2 | Recruiting | Sep 17, 2026 | Jan 1, 2031 (estimated) |
| NCT06362252 | A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03) | Phase 1/Phase 2 | Recruiting | Jul 22, 2024 | Jul 20, 2027 (estimated) |
| NCT06172478 | A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors | Phase 2 | Recruiting | Feb 26, 2024 | Sep 1, 2027 (estimated) |
| NCT05875168 | First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors | Phase 1/Phase 2 | Recruiting | Aug 18, 2023 | Oct 20, 2026 (estimated) |
| NCT07474649 | A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events | Phase 3 | Not yet recruiting | Sep 30, 2026 | Jun 1, 2028 (estimated) |
| NCT03734029 | Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] | Phase 3 | Completed | Dec 27, 2018 | Jan 11, 2022 (actual) |
| NCT06660654 | A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01) | Phase 2 | Active, not recruiting | Jan 6, 2025 | Dec 30, 2029 (estimated) |
| NCT05215340 | Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations | Phase 3 | Active, not recruiting | Mar 4, 2022 | Mar 4, 2030 (estimated) |
| NCT07159126 | A Study of DS3610a in Participants With Advanced Solid Tumor | Phase 1 | Recruiting | Oct 9, 2025 | Sep 1, 2028 (estimated) |
| NCT06824168 | Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission | Phase 2 | Recruiting | Jul 18, 2025 | Jun 6, 2028 (estimated) |
| NCT06244485 | A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors | Phase 1 | Active, not recruiting | Feb 22, 2024 | Nov 1, 2028 (estimated) |
| NCT06899126 | Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer | Phase 3 | Recruiting | Oct 24, 2025 | Apr 24, 2030 (estimated) |
| NCT06644755 | First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors | Phase 1 | Recruiting | Nov 14, 2024 | Nov 30, 2028 (estimated) |
| NCT04707248 | A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors | Phase 1 | Active, not recruiting | Dec 22, 2020 | Dec 30, 2026 (estimated) |
| NCT07182591 | A Study of DS5361b in Participants With Advanced Solid Tumors | Phase 1 | Recruiting | Oct 2, 2025 | Mar 18, 2030 (estimated) |
| NCT07791732 | A Study of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab as Maintenance Therapy in Second-Line Platinum-Sensitive Recurrent Ovarian Cancer (REJOICE-Ovarian03) | Phase 3 | Not yet recruiting | Oct 1, 2026 | Jul 1, 2029 (estimated) |
| NCT03401385 | First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01) | Phase 1 | Active, not recruiting | Jan 31, 2018 | Jan 1, 2028 (estimated) |
| NCT04619004 | HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer | Phase 2 | Active, not recruiting | Feb 2, 2021 | Nov 21, 2022 (actual) |
| NCT05338970 | HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy | Phase 3 | Active, not recruiting | Jul 8, 2022 | May 31, 2024 (actual) |
| NCT04656652 | Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) | Phase 3 | Active, not recruiting | Dec 21, 2020 | May 10, 2024 (actual) |
| NCT07681882 | First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors | Phase 1 | Recruiting | Aug 6, 2026 | Jan 21, 2028 (estimated) |
| NCT07220616 | A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies | Phase 1/Phase 2 | Recruiting | Jan 16, 2026 | Nov 30, 2030 (estimated) |
| NCT07129993 | Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma | Phase 2/Phase 3 | Recruiting | Sep 26, 2025 | Jun 1, 2029 (estimated) |
| NCT06809764 | Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN) | Not listed | Recruiting | Feb 21, 2025 | Feb 12, 2027 (estimated) |
| NCT06846996 | Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China | Not listed | Recruiting | Feb 27, 2025 | Jul 31, 2027 (estimated) |
| NCT06731478 | Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer | Phase 3 | Recruiting | Feb 27, 2025 | Jun 1, 2028 (estimated) |
| NCT06203210 | A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer | Phase 3 | Recruiting | May 21, 2024 | Jan 30, 2028 (estimated) |
| NCT06330064 | A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02) | Phase 1/Phase 2 | Recruiting | Apr 10, 2024 | Jul 25, 2028 (estimated) |
| NCT06644781 | A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01) | Phase 3 | Recruiting | Mar 27, 2025 | Jun 1, 2028 (estimated) |
| NCT07206472 | A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia | Not listed | Recruiting | Mar 3, 2026 | Nov 22, 2028 (estimated) |
| NCT07739966 | A Study of DS-3939a in Participants With Solid Tumors | Phase 1/Phase 2 | Not yet recruiting | Oct 1, 2026 | Jul 31, 2030 (estimated) |
| NCT03030066 | Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas | Phase 1 | Completed | Jan 19, 2017 | Jan 31, 2021 (actual) |
| NCT07022483 | Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer | Phase 3 | Recruiting | Sep 30, 2025 | Mar 23, 2032 (estimated) |
| NCT06644768 | A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations | Phase 1/Phase 2 | Active, not recruiting | Oct 30, 2024 | Mar 30, 2028 (estimated) |
| NCT06161025 | A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | Phase 2/Phase 3 | Recruiting | Feb 27, 2024 | Feb 29, 2028 (estimated) |
| NCT07683754 | T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd | Phase 3 | Not yet recruiting | Sep 4, 2026 | Jul 4, 2030 (estimated) |
| NCT04703192 | Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01) | Phase 2 | Active, not recruiting | Jun 3, 2021 | May 10, 2023 (actual) |
| NCT07015697 | A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors | Phase 1 | Recruiting | Jul 17, 2025 | Dec 31, 2028 (estimated) |
| NCT06578247 | Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML | Phase 3 | Active, not recruiting | Nov 19, 2024 | Jun 26, 2030 (estimated) |
| NCT06819007 | Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01) | Phase 3 | Recruiting | Mar 19, 2025 | Nov 1, 2028 (estimated) |
| NCT04488822 | A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT | Phase 3 | Active, not recruiting | Sep 25, 2020 | Oct 27, 2021 (actual) |
| NCT04703322 | A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan | Phase 2 | Completed | Mar 15, 2021 | Mar 20, 2023 (actual) |
FDA records (last 2 years)
- FDA New indication / efficacy supplement: DATROWAY (datopotamab deruxtecan-dlnk) — BLA761394/3, May 22, 2026. Applicant at approval: Daiichi Sankyo, Inc. source ↗
- FDA New indication / efficacy supplement: ENHERTU (fam-trastuzumab deruxtecan-nxki) — BLA761139/41, May 15, 2026. Applicant at approval: Daiichi Sankyo, Inc. source ↗
- FDA New indication / efficacy supplement: ENHERTU (fam-trastuzumab deruxtecan-nxki) — BLA761139/43, May 15, 2026. Applicant at approval: Daiichi Sankyo, Inc. source ↗
- FDA New indication / efficacy supplement: ENHERTU (fam-trastuzumab deruxtecan-nxki) — BLA761139/39, Apr 27, 2026. Applicant at approval: Daiichi Sankyo, Inc. source ↗
- FDA New indication / efficacy supplement: ENHERTU (fam-trastuzumab deruxtecan-nxki) — BLA761139/38, Dec 15, 2025. Applicant at approval: Daiichi Sankyo, Inc. source ↗
- FDA New indication / efficacy supplement: ENHERTU (fam-trastuzumab deruxtecan-nxki) — BLA761139/32, Jan 27, 2025. Applicant at approval: Daiichi Sankyo, Inc. source ↗
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