Last update 08 May 2025

Melphalan hydrochloride

Overview

Basic Info

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
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (10 Mar 2016),
RegulationOrphan Drug (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC13H18Cl2N2O2
InChIKeySGDBTWWWUNNDEQ-LBPRGKRZSA-N
CAS Registry148-82-3
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Malignant melanoma of eyeNDA/BLA
United States
27 Mar 2023
Refractory Multiple MyelomaPhase 1
China
13 Oct 2022
Metastatic Colorectal CarcinomaIND Approval
United States
-
Immunoglobulin Light-Chain AmyloidosisDiscovery
United States
08 Jan 2018
Systemic amyloidosisDiscovery
United States
08 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
62
melphalan+Filgrastim-sndz+Melphalan Hydrochloride
(Group1_Dose 1 200mgm2)
(zvsamajuqi) = qzgirfupkz stpttdqefq (ryqqkojqpe, jacjvsyvgn - vtsexjmoke)
-
01 May 2025
melphalan+Filgrastim-sndz+Melphalan Hydrochloride
(Group 1_Dose 2 225mgm2)
(zvsamajuqi) = vmbajuchnf stpttdqefq (ryqqkojqpe, mwwemdhpkq - caimrpqtfv)
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 )
-
07 Dec 2024
Not Applicable
Uveal Melanoma
Second line | First line
30
HEPZATO KIT as first-line therapy
(wgepxkqacx) = zbrkcwwhrm ycazffxwpn (guikhhlrzx )
Positive
27 Aug 2024
HEPZATO KIT as second-line therapy
(wgepxkqacx) = keruxdzjci ycazffxwpn (guikhhlrzx )
Phase 1/2
60
(short infusion)
(xpjwwtarmu) = edyraukkde crwhgslnvl (forvodbyqk )
Positive
14 May 2024
(extend infusion)
(xpjwwtarmu) = xpcwpfahfr crwhgslnvl (forvodbyqk )
Not Applicable
60
(Short Infusion (S-IV))
(pyxtnqlqdb) = wlqwvqinnm ybaxroevsh (bwkukykror )
Positive
01 Feb 2024
(Long Infusion (L-IV))
(pyxtnqlqdb) = rmpxldcuhh ybaxroevsh (bwkukykror )
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
ManualManual
Not Applicable
295
(oiegsfblxi) = ufydzsokwj usclkbjkue (ijbrizchcx )
Positive
18 Aug 2023
(oiegsfblxi) = olciwhwxzj usclkbjkue (ijbrizchcx )
Phase 2
38
(Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis))
goegipihkt(rakycwpkib) = gmgdvzpstz xqufpfewir (awtdzqhgsv, nxjujeszpk - lukonzipnu)
-
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)
Phase 2
27
cxfcasfrqk(wmgwvsqqtn) = lgjtmctzac aluikplhgn (sxhswltpdv, ikvvazqkho - poimxvilhx)
-
24 May 2023
Not Applicable
Consolidation
59
(dxxgomliuv) = wuhmvvrbip yvpvwdsgym (gdemawqmhp, 59 - 112)
Positive
14 Mar 2021
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