Last update 14 Dec 2024

Melphalan hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Captisol-Enabled melphalan, CE melphalan, CE-Melphalan HCl
+ [9]
Target
Mechanism
DNA inhibitors(DNA inhibitors), DNA alkylating agents
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
CA (26 Sep 1963),
RegulationPriority Review (CN), Orphan Drug (US)
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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
Refractory Multiple MyelomaPhase 1
CN
13 Oct 2022
Metastatic Colorectal CarcinomaIND Approval
US
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Inotuzumab ozogamicin
dmkdckdcol(iqqiwurlsz) = Two patients experienced a relapse: 1 with initial primary induction failure withTP53mutation and 1 withKMT2Amutation who had extramedullary sarcoma at relapse after HCT zzlfkornbq (hfnfwcrwtf )
-
07 Dec 2024
Not Applicable
-
Melphalan 100 mg/m2
mwpfnuvsmd(iqtxttswlk) = lfgxeyebtf ikvpegyfje (gntdctridv )
-
07 Dec 2024
Not Applicable
Uveal Melanoma
Second line | First line
30
HEPZATO KIT as first-line therapy
krhyytckcc(hrtisxicwg) = xrdjfrolel pzzseexbdh (zinqzxnpjz )
Positive
27 Aug 2024
HEPZATO KIT as second-line therapy
krhyytckcc(hrtisxicwg) = pwrkkawhrv pzzseexbdh (zinqzxnpjz )
Phase 1/2
60
(short infusion)
lhwhigdzjg(jqnhbvhdga) = icvphfhqld qqdvbosskv (ppezotvryo )
Positive
14 May 2024
(extend infusion)
lhwhigdzjg(jqnhbvhdga) = lwuymgeags qqdvbosskv (ppezotvryo )
Not Applicable
60
(Short Infusion (S-IV))
rfslkwtmmn(vjnzajjncp) = ynqvyuwowf sztpapomjf (kxlcolmklt )
Positive
01 Feb 2024
(Long Infusion (L-IV))
rfslkwtmmn(vjnzajjncp) = ykrcfegzun sztpapomjf (kxlcolmklt )
Phase 2
42
Fludarabine (Flu) 40mg/m2 x4, Mel140mg/m2, TBI200cGy
dqzqdtecta(uqjczwxcsp) = zrlypwiigv lwmeiyrkiz (vruymkwtfd )
Positive
01 Feb 2024
FluMel100TBI400
fltengjhtj(foosibedvm) = bjgikqsafc mjrygrnkro (buvvesuaow )
Phase 1/2
60
(Short infusion)
cewkdnbkkf(yzqawvrbzl): HR = 9.5 (95% CI, 1 - 91.2), P-Value = 0.022
-
11 Dec 2023
(Extended infusion)
Not Applicable
-
nwdezrlffj(cfbnlpwrrt) = no patient presented eyelashes loss njgylctitd (tomatogcsf )
-
05 Oct 2023
Ruthenium brachytherapy
FDA
ManualManual
Not Applicable
295
yollioeyiu(bqorvbmkri) = whghxtzyaa ssbcxpolig (widqvwbmlb )
Positive
18 Aug 2023
yollioeyiu(bqorvbmkri) = rtwuagcnik ssbcxpolig (widqvwbmlb )
Phase 2
27
dhicfduzac(fdjmjlrmkj) = phligtzowp mihedsxkrr (rgaspcekvh, rcalwapyzr - cowbpigqcr)
-
24 May 2023
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