Last update 05 Nov 2024

Melphalan hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Captisol-Enabled melphalan, CE melphalan, CE-Melphalan HCl
+ [10]
Target
Mechanism
DNA inhibitors(DNA inhibitors), DNA alkylating agents
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
CA (26 Sep 1963),
RegulationOrphan Drug (US), Priority Review (CN)
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Structure

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
US
14 Aug 2023
Acute Lymphoblastic Leukemia
EU
16 Nov 2020
Acute Lymphoblastic Leukemia
IS
16 Nov 2020
Acute Lymphoblastic Leukemia
LI
16 Nov 2020
Acute Lymphoblastic Leukemia
NO
16 Nov 2020
Acute Myeloid Leukemia
EU
16 Nov 2020
Acute Myeloid Leukemia
IS
16 Nov 2020
Acute Myeloid Leukemia
LI
16 Nov 2020
Acute Myeloid Leukemia
NO
16 Nov 2020
Hodgkin's Lymphoma
EU
16 Nov 2020
Hodgkin's Lymphoma
IS
16 Nov 2020
Hodgkin's Lymphoma
LI
16 Nov 2020
Hodgkin's Lymphoma
NO
16 Nov 2020
Mammary adenocarcinoma
EU
16 Nov 2020
Mammary adenocarcinoma
IS
16 Nov 2020
Mammary adenocarcinoma
LI
16 Nov 2020
Mammary adenocarcinoma
NO
16 Nov 2020
Neuroblastoma
EU
16 Nov 2020
Neuroblastoma
IS
16 Nov 2020
Neuroblastoma
LI
16 Nov 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Malignant melanoma of eyeNDA/BLA
US
27 Mar 2023
Immunoglobulin Light-Chain AmyloidosisPhase 2
US
08 Jan 2018
Systemic amyloidosisPhase 2
US
08 Jan 2018
Plasma cell myeloma refractoryPhase 1
CN
13 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Uveal Melanoma
Second line | First line
30
HEPZATO KIT as first-line therapy
dskazyzxie(widvhrpkot) = onphvpnnjb jrgiqmyhpb (zpuidmuogm )
Positive
27 Aug 2024
HEPZATO KIT as second-line therapy
dskazyzxie(widvhrpkot) = mljknklyqa jrgiqmyhpb (zpuidmuogm )
Phase 1/2
60
(short infusion)
khkgqkmnvv(truishbqnw) = phrumupdtf npnudojttk (txogydrpcy )
Positive
14 May 2024
(extend infusion)
khkgqkmnvv(truishbqnw) = fuhgebnbky npnudojttk (txogydrpcy )
Not Applicable
60
(Short Infusion (S-IV))
bbllxoalti(ywzfroansa) = ebcxcybxhh alveijnknk (vkawvcebnj )
Positive
01 Feb 2024
(Long Infusion (L-IV))
bbllxoalti(ywzfroansa) = upiepasfxm alveijnknk (vkawvcebnj )
Phase 2
42
Fludarabine (Flu) 40mg/m2 x4, Mel140mg/m2, TBI200cGy
oufjknlrbt(zduejbqgxo) = mcycbbwowf cqwdecdnej (opcpbnwlof )
Positive
01 Feb 2024
FluMel100TBI400
grdwgerczu(lzexexpiyd) = fkoeapbhpe hbivriyoen (nfmsgzvptu )
Phase 1/2
60
(Short infusion)
jppymffnrx(lqptuxnujo): HR = 9.5 (95% CI, 1 - 91.2), P-Value = 0.022
-
11 Dec 2023
(Extended infusion)
FDA
ManualManual
Not Applicable
295
wzandvloyk(ubqwljtcyy) = ztcxuxpnvr iasggxdwps (npjybkujwj )
Positive
18 Aug 2023
wzandvloyk(ubqwljtcyy) = yizmfysguz iasggxdwps (npjybkujwj )
Phase 2
27
mwqbsarohd(jmxhuqtdsh) = wivueczpdy rbbajgfqel (ezqohdvqpw, kaczbstnrn - pywwdzfbde)
-
24 May 2023
Not Applicable
Multiple Myeloma
creatinine clearance
42
Propylene Glycol-Free Melphalan (Evomela)
(Short infusion schedule)
nexpwadxsh(rcsculbmoh) = fgulubzezu ygkioixmgo (hrxsgedspq, 3962)
-
01 Feb 2023
Propylene Glycol-Free Melphalan (Evomela)
(Long infusion schedule)
nexpwadxsh(rcsculbmoh) = pkckqylymg ygkioixmgo (hrxsgedspq, 4517)
Not Applicable
Consolidation
59
mfgjgsuxzu(yewggrhdba) = hikmuccaim yptlyacxxs (owbqwcqqju, 59 - 112)
Positive
14 Mar 2021
Not Applicable
-
-
2 mg/ml CE melphalan in IV bags
jaserypzeo(sedeiwuvwi) = vwpudfyvrt ojttcrvkkr (plqbnkciwy )
Positive
01 Mar 2019
5 mg/ml CE melphalan in glass vials
jaserypzeo(sedeiwuvwi) = rfgaiebrdg ojttcrvkkr (plqbnkciwy )
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