Drugs / Ifinatamab Deruxtecan
Ifinatamab Deruxtecan
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | small cell lung carcinoma | 2026-04-13 | “Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA)” merck.com ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/29 trials | ||||||
| Phase 1/2 | NCT07630974 | Jul 2026 → Aug 2031 expected | cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07405151 | Mar 2026 → Jun 2027 expected | esophageal squamous cell carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07227597 | Jan 2026 → Nov 2030 expected | small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06780111 | Jul 2025 → Jan 2032 expected | esophageal squamous cell carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06863272 | Jul 2025 → Oct 2031 expected | castration-resistant prostate carcinoma, metastatic neoplasm | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06780137 | Feb 2025 → Feb 2029 expected | small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06362252 | Jul 2024 → Jul 2027 expected | small cell lung carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04165070 | Dec 2019 → Feb 2032 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04145622 | Nov 2019 → Apr 2027 expected | cancer | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06780085 | May 2025 → Mar 2032 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06330064 | Apr 2024 → Jul 2028 expected | — | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06925737 | May 2025 → Jun 2028 expected | prostate cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06644781 | Mar 2025 → Jun 2028 expected | esophageal squamous cell carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT06203210 | May 2024 → Apr 2027 expected | small cell lung carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT07535359 | — | small cell lung carcinoma | Daiichi Sankyo | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT04471727 Background | Dec 2020 → Jan 2028 expected | small cell lung carcinoma | Harpoon Therapeutics, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-08-18 | Merck Sharp & Dohme LLC | Regulatory Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer merck.com ↗
Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. |
All press releases naming this drug 7 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ifinatamab deruxtecan | “The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC).” NCT07405151 ↗14“Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC).” NCT06780111 ↗ |
| Known as | DS-7300a | “Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors” NCT04145622 ↗ |
| Known as | I-DXd | “The study treatment I-DXd (also known as MK-2400 or ifinatamab deruxtecan) is an antibody-drug conjugate (ADC).” NCT07630974 ↗5“Biological: Ifinatamab Deruxtecan (I-DXd)” NCT04471727 ↗ “Ifinatamab deruxtecan (I-DXd)” NCT04145622 ↗ |
| Known as | Mabx-9001a cysteinyl-deruxtecan | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095331 ↗ |
| Known as | MK-2400 | “The study treatment I-DXd (also known as MK-2400 or ifinatamab deruxtecan) is an antibody-drug conjugate (ADC).” NCT07630974 ↗ |
| Action | Deplete | “An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells.” NCT06780085 ↗ |
| Modality | Other / unclassified | “a B7-H3 Antibody-Drug Conjugate (ADC)” NCT06362252 ↗ |
| Route | Intravenous | “Patients received ifinatamab deruxtecan at doses of 0·8-16·0 mg/kg intravenously every 3 weeks.” PMID 41926962 ↗ Apr 2026 |