Drug Type Small molecule drug |
Synonyms CE melphalan, CE-Melphalan HCl, Captisol-Enabled melphalan + [10] |
Target |
Action inhibitors |
Mechanism DNA inhibitors(DNA inhibitors), DNA alkylating agents |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (10 Mar 2016), |
RegulationOrphan Drug (United States), Priority Review (China) |
Molecular FormulaC13H18Cl2N2O2 |
InChIKeySGDBTWWWUNNDEQ-LBPRGKRZSA-N |
CAS Registry148-82-3 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D08173 | Melphalan hydrochloride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Acute Myeloid Leukemia | European Union | 16 Nov 2020 | |
Acute Myeloid Leukemia | Iceland | 16 Nov 2020 | |
Acute Myeloid Leukemia | Liechtenstein | 16 Nov 2020 | |
Hodgkin's Lymphoma | Iceland | 16 Nov 2020 | |
Hodgkin's Lymphoma | Liechtenstein | 16 Nov 2020 | |
Hodgkin's Lymphoma | Norway | 16 Nov 2020 | |
Hodgkin's Lymphoma | European Union | 16 Nov 2020 | |
Neuroblastoma | Liechtenstein | 16 Nov 2020 | |
Neuroblastoma | Iceland | 16 Nov 2020 | |
Neuroblastoma | European Union | 16 Nov 2020 | |
Neuroblastoma | Norway | 16 Nov 2020 | |
Non-Hodgkin Lymphoma | Iceland | 16 Nov 2020 | |
Non-Hodgkin Lymphoma | Liechtenstein | 16 Nov 2020 | |
Non-Hodgkin Lymphoma | Norway | 16 Nov 2020 | |
Non-Hodgkin Lymphoma | European Union | 16 Nov 2020 | |
Ovarian Cancer | European Union | 16 Nov 2020 | |
Ovarian Cancer | Iceland | 16 Nov 2020 | |
Ovarian Cancer | Liechtenstein | 16 Nov 2020 | |
Ovarian Cancer | Norway | 16 Nov 2020 | |
Multiple Myeloma | United States | 10 Mar 2016 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Malignant melanoma of eye | NDA/BLA | United States | 27 Mar 2023 | |
Refractory Multiple Myeloma | Phase 1 | China | 13 Oct 2022 | |
Metastatic Colorectal Carcinoma | IND Approval | United States | - | |
Immunoglobulin Light-Chain Amyloidosis | Discovery | United States | 08 Jan 2018 | |
Systemic amyloidosis | Discovery | United States | 08 Jan 2018 |
Phase 1/2 | 62 | melphalan+Filgrastim-sndz+Melphalan Hydrochloride (Group1_Dose 1 200mgm2) | (zvsamajuqi) = qzgirfupkz stpttdqefq (ryqqkojqpe, jacjvsyvgn - vtsexjmoke) View more | - | 01 May 2025 | ||
melphalan+Filgrastim-sndz+Melphalan Hydrochloride (Group 1_Dose 2 225mgm2) | (zvsamajuqi) = vmbajuchnf stpttdqefq (ryqqkojqpe, mwwemdhpkq - caimrpqtfv) View more | ||||||
Not Applicable | - | Inotuzumab ozogamicin | hnkrjxubgr(tnpoadzvnf) = Two patients experienced a relapse: 1 with initial primary induction failure withTP53mutation and 1 withKMT2Amutation who had extramedullary sarcoma at relapse after HCT knzxlvqsun (okgzthzuzc ) View more | - | 07 Dec 2024 | ||
BusinessWire Manual | Not Applicable | Uveal Melanoma Second line | First line | 30 | HEPZATO KIT as first-line therapy | (wgepxkqacx) = zbrkcwwhrm ycazffxwpn (guikhhlrzx ) View more | Positive | 27 Aug 2024 |
HEPZATO KIT as second-line therapy | (wgepxkqacx) = keruxdzjci ycazffxwpn (guikhhlrzx ) View more | ||||||
Phase 1/2 | Multiple Myeloma First line | 60 | (short infusion) | (xpjwwtarmu) = edyraukkde crwhgslnvl (forvodbyqk ) View more | Positive | 14 May 2024 | |
(extend infusion) | (xpjwwtarmu) = xpcwpfahfr crwhgslnvl (forvodbyqk ) View more | ||||||
Not Applicable | Multiple Myeloma First line | 60 | (Short Infusion (S-IV)) | (pyxtnqlqdb) = wlqwvqinnm ybaxroevsh (bwkukykror ) View more | Positive | 01 Feb 2024 | |
(Long Infusion (L-IV)) | (pyxtnqlqdb) = rmpxldcuhh ybaxroevsh (bwkukykror ) View more | ||||||
Phase 1/2 | 60 | (Short infusion) | (iezvtovxam): HR = 9.5 (95% CI, 1 - 91.2), P-Value = 0.022 | - | 11 Dec 2023 | ||
(Extended infusion) | |||||||
FDA Manual | Not Applicable | 295 | (Oral) | (oiegsfblxi) = ufydzsokwj usclkbjkue (ijbrizchcx ) View more | Positive | 18 Aug 2023 | |
(oiegsfblxi) = olciwhwxzj usclkbjkue (ijbrizchcx ) View more | |||||||
Phase 2 | Recurrent Multiple Myeloma | Hodgkin's Lymphoma | Chronic Lymphocytic Leukemia | Diffuse Large B-Cell Lymphoma | acute leukemia | Acute Myeloid Leukemia with Myelodysplasia-Related Changes | Graft vs Host Disease | Mantle-Cell Lymphoma | Secondary Myelodysplastic Syndrome | Follicular Lymphoma | Philadelphia chromosome positive chronic myelogenous leukemia | Refractory Multiple Myeloma | Marginal Zone B-Cell Lymphoma | 38 | Peripheral Blood Stem Cell Transplantation+Fludarabine Phosphate+cyclophosphamide+Tacrolimus+Mycophenolate Mofetil+Melphalan Hydrochloride (Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)) | goegipihkt(rakycwpkib) = gmgdvzpstz xqufpfewir (awtdzqhgsv, nxjujeszpk - lukonzipnu) View more | - | 09 Jun 2023 | |
Peripheral Blood Stem Cell Transplantation+Fludarabine Phosphate+cyclophosphamide+Tacrolimus+Mycophenolate Mofetil (Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)) | goegipihkt(rakycwpkib) = fclxtvbgdk xqufpfewir (awtdzqhgsv, vstzgoqivq - dqslfoqnzy) View more | ||||||
Phase 2 | 27 | cxfcasfrqk(wmgwvsqqtn) = lgjtmctzac aluikplhgn (sxhswltpdv, ikvvazqkho - poimxvilhx) View more | - | 24 May 2023 | |||
Not Applicable | Consolidation | 59 | (dxxgomliuv) = wuhmvvrbip yvpvwdsgym (gdemawqmhp, 59 - 112) View more | Positive | 14 Mar 2021 |