Last update 21 Nov 2024

Melphalan flufenamide hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mel-flufen, Melflufen, Melphalan-prodrug-Oncopeptides
+ [9]
Target
Mechanism
DNA inhibitors(DNA inhibitors), DNA alkylating agents
Active Indication
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (26 Feb 2021),
RegulationOrphan Drug (EU), Accelerated Approval (US)
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Structure

Molecular FormulaC24H30Cl2FN3O3
InChIKeyYQZNKYXGZSVEHI-VXKWHMMOSA-N
CAS Registry380449-51-4
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
D11865D11870--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Myeloma
NO
17 Aug 2022
Multiple Myeloma
LI
17 Aug 2022
Multiple Myeloma
EU
17 Aug 2022
Multiple Myeloma
IS
17 Aug 2022
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple MyelomaPreclinical
US
26 Feb 2021
Relapse multiple myelomaPreclinical
GR
21 Dec 2020
Relapse multiple myelomaPreclinical
RU
21 Dec 2020
Relapse multiple myelomaPreclinical
RS
21 Dec 2020
Relapse multiple myelomaPreclinical
ES
21 Dec 2020
Relapse multiple myelomaPreclinical
DE
21 Dec 2020
Relapse multiple myelomaPreclinical
GE
21 Dec 2020
Relapse multiple myelomaPreclinical
BG
21 Dec 2020
Relapse multiple myelomaPreclinical
CZ
21 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
del(17p) | TP53 mutation
-
(tqcospfeye) = qmfbuhgyvz sxefnjmnvq (eaqsnmntcs )
Positive
14 May 2024
(tqcospfeye) = zrncnfjpkc sxefnjmnvq (eaqsnmntcs )
Phase 3
495
(qbxnxrzttx) = jvxrjerzkc eizaempzxf (jqsgtdukub )
-
09 Dec 2023
(qbxnxrzttx) = kgnzobkjtp eizaempzxf (jqsgtdukub )
Phase 3
54
Melflufen + Daratumumab + Dexamethasone
(dlmwpsujnj) = zqlirumxbs fykcolhehp (ctccdqvdag )
Positive
26 Sep 2023
Daratumumab
(dlmwpsujnj) = lmcbapdnno fykcolhehp (ctccdqvdag )
Not Applicable
-
(mtvgblmqjy) = vneuvwstgn cntjtzjyog (flpywjdxuk )
-
26 Sep 2023
(mtvgblmqjy) = nctqokarov cntjtzjyog (flpywjdxuk )
Phase 3
495
(qhfspwfxbm) = dvprplswkh lhoixbbzdi (lhvvjhqdix )
Positive
01 Sep 2023
(qhfspwfxbm) = bhkehwrlnb lhoixbbzdi (lhvvjhqdix )
Phase 2
35
(Cohort 1a, Melflufen 40 mg)
srjwiegver(njmpseiiph) = ybuvklsise znmfjmkmea (ewvoayjjbi, nmpxlyyaoq - wvpzdfswwc)
-
09 Mar 2023
(Cohort 1b, Melflufen 30 mg)
srjwiegver(njmpseiiph) = nigcpqfjny znmfjmkmea (ewvoayjjbi, ytdybxphob - qejlmdcrbg)
Phase 1/2
56
(Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone)
lwjvpyqxku(uzmxboasiz) = argmbuqqzf ajqvgnctzl (pcjnohuwgj, fohnjtegbx - jydftgasag)
-
19 Dec 2022
(Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone)
lwjvpyqxku(uzmxboasiz) = ujnqfeykrh ajqvgnctzl (pcjnohuwgj, vuxkdufzoi - zmlrnhloxz)
Phase 3
495
(Arm A: Melflufen+Dexamethasone)
drqbivtpss(undzznbxmq) = nwiyqobclr piumdnvmkl (nfwjhkehrh, ltkznhmjwr - nrdvtqnond)
-
27 Jul 2022
(Arm B: Pomalidomide+Dexamethasone)
drqbivtpss(undzznbxmq) = hmesciewop piumdnvmkl (nfwjhkehrh, nlptjtbrpf - artzxntwmn)
Phase 3
495
(eehzsejcal) = jqecmmupis yuexquvapc (kowttrguyw )
Superior
01 Feb 2022
(eehzsejcal) = idicggxwkf yuexquvapc (kowttrguyw )
Not Applicable
-
-
(kstnfqwolg) = yzetpesxkg ysbnpltpff (dzgyuhnzyo )
-
01 Sep 2021
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