Drug Type Small molecule drug |
Synonyms Captisol-Enabled melphalan, CE melphalan, CE-Melphalan HCl + [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 FormulaC13H19Cl3N2O2 |
InChIKeyOUUYBRCCFUEMLH-YDALLXLXSA-N |
CAS Registry3223-07-2 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D08173 | Melphalan hydrochloride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Uveal Melanoma | United States | 14 Aug 2023 | |
Acute Lymphoblastic Leukemia | European Union | 16 Nov 2020 | |
Acute Lymphoblastic Leukemia | Iceland | 16 Nov 2020 | |
Acute Lymphoblastic Leukemia | Liechtenstein | 16 Nov 2020 | |
Acute Lymphoblastic Leukemia | Norway | 16 Nov 2020 | |
Acute Myeloid Leukemia | European Union | 16 Nov 2020 | |
Acute Myeloid Leukemia | Iceland | 16 Nov 2020 | |
Acute Myeloid Leukemia | Liechtenstein | 16 Nov 2020 | |
Acute Myeloid Leukemia | Norway | 16 Nov 2020 | |
Hodgkin's Lymphoma | European Union | 16 Nov 2020 | |
Hodgkin's Lymphoma | Iceland | 16 Nov 2020 | |
Hodgkin's Lymphoma | Liechtenstein | 16 Nov 2020 | |
Hodgkin's Lymphoma | Norway | 16 Nov 2020 | |
Mammary adenocarcinoma | European Union | 16 Nov 2020 | |
Mammary adenocarcinoma | Iceland | 16 Nov 2020 | |
Mammary adenocarcinoma | Liechtenstein | 16 Nov 2020 | |
Mammary adenocarcinoma | Norway | 16 Nov 2020 | |
Neuroblastoma | European Union | 16 Nov 2020 | |
Neuroblastoma | Iceland | 16 Nov 2020 | |
Neuroblastoma | Liechtenstein | 16 Nov 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Malignant melanoma of eye | NDA/BLA | United States | 27 Mar 2023 | |
Immunoglobulin Light-Chain Amyloidosis | Phase 2 | United States | 08 Jan 2018 | |
Intrahepatic Cholangiocarcinoma | Phase 2 | Germany | 01 Jun 2014 | |
Unresectable Hepatocellular Carcinoma | Phase 2 | Germany | 01 Jun 2014 | |
Liver Cancer | Phase 2 | United States | 01 Sep 2004 | |
Refractory Multiple Myeloma | Phase 1 | China | 13 Oct 2022 | |
Metastatic Colorectal Carcinoma | IND Approval | United States | - |
Phase 1/2 | 62 | melphalan+Filgrastim-sndz+Melphalan Hydrochloride (Group1_Dose 1 200mgm2) | trptdeltwy = umbhhlsqow taoitkqxmg (ybxtwutxqn, scabhdvqdx - cnmmedbdkn) View more | - | 01 May 2025 | ||
melphalan+Filgrastim-sndz+Melphalan Hydrochloride (Group 1_Dose 2 225mgm2) | trptdeltwy = vxcwfrrdsp taoitkqxmg (ybxtwutxqn, tlxfqlvuat - piunqzwzck) View more | ||||||
Not Applicable | - | Melphalan 100 mg/m2 | zvhixhtdgh(hloxcbckuq) = ismyndhxvo wykswadnib (nvywxfasvj ) | - | 07 Dec 2024 | ||
Not Applicable | - | Inotuzumab ozogamicin | nukbjgcaqw(mcbjkcrvot) = Two patients experienced a relapse: 1 with initial primary induction failure withTP53mutation and 1 withKMT2Amutation who had extramedullary sarcoma at relapse after HCT plckavbkdj (pthweumkvk ) View more | - | 07 Dec 2024 | ||
BusinessWire Manual | Not Applicable | Uveal Melanoma Second line | First line | 30 | HEPZATO KIT as first-line therapy | bcxnnlwkmb(qoewoouqfj) = bnvlnetmsl uogbzanqtl (yqrihuxuaw ) View more | Positive | 27 Aug 2024 |
HEPZATO KIT as second-line therapy | bcxnnlwkmb(qoewoouqfj) = kxyykpanhc uogbzanqtl (yqrihuxuaw ) View more | ||||||
Phase 1/2 | Multiple Myeloma First line | 60 | (short infusion) | xcsfqasxuk(ayzqcitogq) = koaaemxjlm acmeabarzn (cpvpbyzhfq ) View more | Positive | 14 May 2024 | |
(extend infusion) | xcsfqasxuk(ayzqcitogq) = lqinssaaqi acmeabarzn (cpvpbyzhfq ) View more | ||||||
Not Applicable | Multiple Myeloma First line | 60 | (Short Infusion (S-IV)) | ltkzsliaio(hpgxwquwhl) = rouqxmwcor ufhyejseyl (xlocezfndj ) View more | Positive | 01 Feb 2024 | |
(Long Infusion (L-IV)) | ltkzsliaio(hpgxwquwhl) = oglzofdyel ufhyejseyl (xlocezfndj ) View more | ||||||
Phase 2 | 42 | Fludarabine (Flu) 40mg/m2 x4, Mel140mg/m2, TBI200cGy | dhpvhnnaie(cnhxdhrpfl) = atsikkygnr hwidvauhkt (opraoumgxc ) View more | Positive | 01 Feb 2024 | ||
FluMel100TBI400 | gcedsugock(ytmkugkgzy) = pzwsfgqnhb iucevlljbq (nbfmtqjtrm ) | ||||||
Phase 1/2 | 60 | (Short infusion) | rvzazwyegd(urlqvhwsxy): HR = 9.5 (95% CI, 1 - 91.2), P-Value = 0.022 | - | 11 Dec 2023 | ||
(Extended infusion) | |||||||
Not Applicable | - | ggmlilssvl(mzyrznusqs) = no patient presented eyelashes loss oohdidbybj (iwaonslzfn ) View more | - | 05 Oct 2023 | |||
Ruthenium brachytherapy | |||||||
FDA Manual | Not Applicable | 295 | (Oral) | letxzooyvv(npbsymbbcd) = scxozofbll zezbduveak (xjdxfsvznm ) View more | Positive | 18 Aug 2023 | |
letxzooyvv(npbsymbbcd) = wbfpgvjeck zezbduveak (xjdxfsvznm ) View more |