Last update 28 May 2025

Melphalan hydrochloride

Overview

Basic Info

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
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 FormulaC13H19Cl3N2O2
InChIKeyOUUYBRCCFUEMLH-YDALLXLXSA-N
CAS Registry3223-07-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Malignant melanoma of eyeNDA/BLA
United States
27 Mar 2023
Immunoglobulin Light-Chain AmyloidosisPhase 2
United States
08 Jan 2018
Intrahepatic CholangiocarcinomaPhase 2
Germany
01 Jun 2014
Unresectable Hepatocellular CarcinomaPhase 2
Germany
01 Jun 2014
Liver CancerPhase 2
United States
01 Sep 2004
Refractory Multiple MyelomaPhase 1
China
13 Oct 2022
Metastatic Colorectal CarcinomaIND Approval
United States
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
62
melphalan+Filgrastim-sndz+Melphalan Hydrochloride
(Group1_Dose 1 200mgm2)
trptdeltwy = umbhhlsqow taoitkqxmg (ybxtwutxqn, scabhdvqdx - cnmmedbdkn)
-
01 May 2025
melphalan+Filgrastim-sndz+Melphalan Hydrochloride
(Group 1_Dose 2 225mgm2)
trptdeltwy = vxcwfrrdsp taoitkqxmg (ybxtwutxqn, tlxfqlvuat - piunqzwzck)
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 )
-
07 Dec 2024
Not Applicable
Uveal Melanoma
Second line | First line
30
HEPZATO KIT as first-line therapy
bcxnnlwkmb(qoewoouqfj) = bnvlnetmsl uogbzanqtl (yqrihuxuaw )
Positive
27 Aug 2024
HEPZATO KIT as second-line therapy
bcxnnlwkmb(qoewoouqfj) = kxyykpanhc uogbzanqtl (yqrihuxuaw )
Phase 1/2
60
(short infusion)
xcsfqasxuk(ayzqcitogq) = koaaemxjlm acmeabarzn (cpvpbyzhfq )
Positive
14 May 2024
(extend infusion)
xcsfqasxuk(ayzqcitogq) = lqinssaaqi acmeabarzn (cpvpbyzhfq )
Not Applicable
60
(Short Infusion (S-IV))
ltkzsliaio(hpgxwquwhl) = rouqxmwcor ufhyejseyl (xlocezfndj )
Positive
01 Feb 2024
(Long Infusion (L-IV))
ltkzsliaio(hpgxwquwhl) = oglzofdyel ufhyejseyl (xlocezfndj )
Phase 2
42
Fludarabine (Flu) 40mg/m2 x4, Mel140mg/m2, TBI200cGy
dhpvhnnaie(cnhxdhrpfl) = atsikkygnr hwidvauhkt (opraoumgxc )
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 )
-
05 Oct 2023
Ruthenium brachytherapy
FDA
ManualManual
Not Applicable
295
letxzooyvv(npbsymbbcd) = scxozofbll zezbduveak (xjdxfsvznm )
Positive
18 Aug 2023
letxzooyvv(npbsymbbcd) = wbfpgvjeck zezbduveak (xjdxfsvznm )
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Regulation

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