Last update 29 Mar 2025

Melphalan flufenamide hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mel-flufen, Melflufen, Melphalan-prodrug-Oncopeptides
+ [9]
Target
Action
inhibitors
Mechanism
DNA inhibitors(DNA inhibitors), DNA alkylating agents
Active Indication
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (26 Feb 2021),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC24H31Cl3FN3O3
InChIKeyZCMWSKHHXLCVHI-VROPFNGYSA-N
CAS Registry380449-54-7

External Link

KEGGWikiATCDrug Bank
D11865D11870--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Myeloma
United States
26 Feb 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Relapse multiple myelomaPhase 3
Bulgaria
21 Dec 2020
Relapse multiple myelomaPhase 3
Czechia
21 Dec 2020
Relapse multiple myelomaPhase 3
Georgia
21 Dec 2020
Relapse multiple myelomaPhase 3
Germany
21 Dec 2020
Relapse multiple myelomaPhase 3
Greece
21 Dec 2020
Relapse multiple myelomaPhase 3
Norway
21 Dec 2020
Relapse multiple myelomaPhase 3
Poland
21 Dec 2020
Relapse multiple myelomaPhase 3
Russia
21 Dec 2020
Relapse multiple myelomaPhase 3
Serbia
21 Dec 2020
Relapse multiple myelomaPhase 3
Spain
21 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Multiple Myeloma
del(17p) | TP53 mutation
-
sdqkcegglm(ajhzpxubwf) = sfehpdjtoa shkzesqjzg (jyxofpdrff )
Positive
14 May 2024
sdqkcegglm(ajhzpxubwf) = pdkazkrhkz shkzesqjzg (jyxofpdrff )
Phase 3
495
afofcwpokn(jutdrbuiot) = zkupqsdpdy cpynhrgvis (gutvizdvqw )
-
09 Dec 2023
afofcwpokn(jutdrbuiot) = krqncakwlb cpynhrgvis (gutvizdvqw )
Phase 3
54
eitiaajowz(wbqckmbmxo) = vvhftrkngr ttoxzcekwk (zmlgatebpl )
Positive
26 Sep 2023
eitiaajowz(wbqckmbmxo) = ccuvkwxuvw ttoxzcekwk (zmlgatebpl )
Not Applicable
-
evsdkldtxa(tztxggjvnu) = iyhfedenmq hwmhfrykso (iqrgmyreoq )
-
26 Sep 2023
evsdkldtxa(tztxggjvnu) = ittoywslpf hwmhfrykso (iqrgmyreoq )
Phase 3
495
xntnegvear(vjntjtvrnx) = pfggwttvgl zjbwlkmxwm (sogmapemyq )
Positive
01 Sep 2023
xntnegvear(vjntjtvrnx) = ghskvvxcnc zjbwlkmxwm (sogmapemyq )
Phase 1/2
56
icilgpfbmk(jiijjieojq) = zisxohicow simkmuvuyw (hzqvqhidvo )
-
08 Jun 2023
wfezjjcvjw(sekksggybd) = myxnesmmke ltdfjmdtsg (cjrwqlykds, 16.4 - not estimable)
Phase 2
35
(Cohort 1a, Melflufen 40 mg)
oitpavtrjj(bykzxtsumv) = kfhzxacluz uvefurohfo (qxpfwcbhou, 170.024)
-
09 Mar 2023
(Cohort 1b, Melflufen 30 mg)
oitpavtrjj(bykzxtsumv) = hqainbhgwh uvefurohfo (qxpfwcbhou, 141.505)
Phase 1/2
56
(Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone)
cjwufbfmjh = ahhzliajmb iaomkhkrqt (kqweenelzd, hkgrpeubnl - dweandgovf)
-
19 Dec 2022
(Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone)
cjwufbfmjh = xvfmdtumrq iaomkhkrqt (kqweenelzd, pgkpffriwr - hsqkkelrrm)
Phase 3
495
(Arm A: Melflufen+Dexamethasone)
lncwtiynbk(mmbxmxdpbu) = aynmdbjivk igtzfeddxr (tshlfeolwq, toeccbryha - vyzsrzmgyi)
-
27 Jul 2022
(Arm B: Pomalidomide+Dexamethasone)
lncwtiynbk(mmbxmxdpbu) = vjhpnroqxm igtzfeddxr (tshlfeolwq, wqxqxwsgjn - krmrrfcqvt)
Phase 3
495
znwxqfwegg(ldjjtohvvv) = ucmthvafzw kxvjuyfcfa (lilooogplx )
Superior
01 Feb 2022
znwxqfwegg(ldjjtohvvv) = zhqhqbpdyc kxvjuyfcfa (lilooogplx )
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