Drugs / Melphalan flufenamide
Melphalan flufenamide
also known as
Melflufen · CK 1535 · J 1 (PRODRUG) · J-1 HYDROCHLORIDE · Melfalan flufenamida · Melflufen hydrochloride · MELPHALAN FLUFENAMIDE HYDROCHLORIDE · Pepaxti · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Pepaxti | — | 2022-08-17 | europa.eu ↗ |
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04115956 | Aug 2020 → Jan 2022 | AL amyloidosis | Oncopeptides AB | Terminated | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03481556 | Apr 2018 → Feb 2022 | plasma cell myeloma | Oncopeptides AB | Terminated | No outcome recorded |
| Phase 1/2 | NCT01897714 | Jul 2013 → Dec 2017 | indolent plasma cell myeloma | Oncopeptides AB | Terminated | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06682637 | Mar 2025 | — | Fondazione EMN Italy Onlus | Withdrawn | No outcome recorded |
| Phase 2 | NCT03639610 | Aug 2018 → Dec 2021 | impaired renal function disease, plasma cell myeloma | Oncopeptides AB | Terminated | No outcome recorded |
| Phase 2 | NCT02963493 | Dec 2016 → Oct 2020 | plasma cell myeloma | Oncopeptides AB | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04649060 | Dec 2020 → Feb 2022 | plasma cell myeloma, refractory plasma cell neoplasm | Oncopeptides AB | Terminated | No outcome recorded |
| Phase 3 | NCT03151811 | Jun 2017 → Feb 2021 | plasma cell myeloma | Oncopeptides AB | Terminated | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04534322 | — | refractory plasma cell neoplasm | Oncopeptides AB | Approved for marketing | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Melphalan-flufenamide | “An Open-Label Phase I/IIa Study of the Safety and Efficacy of Melphalan-flufenamide (Melflufen) and Dexamethasone Combination for Patients With Relapsed and/or...” NCT01897714 ↗ |
| Known as | CK 1535 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303060 ↗ |
| Known as | J 1 (PRODRUG) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303060 ↗ |
| Known as | J-1 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303060 ↗ |
| Known as | Melfalan flufenamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303060 ↗ |
| Known as | Melflufen | “Melphalan flufenamide (melflufen) is a peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells.” NCT02963493 ↗ |
| Known as | Melflufen hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303060 ↗ |
| Known as | MELPHALAN FLUFENAMIDE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303060 ↗ |
| Known as | Pepaxti | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303060 ↗ |
| Known as | Pepaxto | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303060 ↗ |
| Known as | PRODRUG J 1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303060 ↗ |
| Modality | Peptide | “Melphalan flufenamide (melflufen) is a peptide-drug conjugate” NCT02963493 ↗ |
| Route | Intravenous | “patients received an intravenous infusion of melflufen at 15 mg, 25 mg, 40 mg, or 55 mg” PMID 32213344 ↗ Mar 2020 |