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melphalan

Trade name: alkeran

Small moleculeapproved

Approved

Jan 17, 1964

Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent which produces a number of DNA adducts with the DNA interstrand crosslink (ICL) considered to be the critical cytotoxic lesion. Melphalan is used to treat different cancers including myeloma, melanoma and ovarian cancer. — NCATS

Clinical trial activity

728 trials · 405 clinical orgs · 36 marketing orgs

Phase 1
211
Phase 2
550
Phase 3
115
Phase 4
4

Earliest trial started Jul 1, 1990 (NCT00002802)

Timeline

1960s

  1. Jan 17, 1964

    Apotex — Earliest FDA Approval

  2. Jan 17, 1964

    Apotex — NDA Secondary Org

  3. Jan 17, 1964

    Apotex — Marketing Organization

  4. Jan 17, 1964

    Apotex — NDA Organization

1990s

  1. Jan 1, 1990

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1991

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 1992

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jun 9, 2009

    Mylan — Marketing Organization

2010s

  1. Oct 28, 2010

    West-Ward Pharmaceutical — Marketing Organization

  2. Oct 28, 2010

    Hikma — Marketing Organization

  3. Mar 10, 2016

    Spectrum Pharmaceuticals — NDA Secondary Org

  4. Mar 10, 2016

    Aurobindo Pharma — Marketing Organization

  5. Mar 10, 2016

    Acrotech Biopharma LLC — NDA Secondary Org

  6. Aug 22, 2016

    Par Pharmaceuticals — Marketing Organization

  7. Aug 22, 2016

    Bristol-Myers Squibb — Marketing Organization

  8. Aug 22, 2016

    Endo Pharmaceuticals — Marketing Organization

  9. Aug 22, 2016

    PH HEALTH — Marketing Organization

  10. Dec 19, 2016

    Actavis — Marketing Organization

  11. Dec 19, 2016

    Allergan PLC (2015) — Marketing Organization

  12. Feb 28, 2017

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  13. Feb 28, 2017

    Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization

  14. Mar 22, 2017

    Alvogen — Marketing Organization

  15. Dec 8, 2017

    Dr. Reddy's Laboratories — Marketing Organization

  16. Dec 22, 2017

    Fresenius — Marketing Organization

  17. May 3, 2019

    US WorldMeds — Marketing Organization

  18. May 17, 2019

    Almaject — Marketing Organization

  19. May 28, 2019

    Gland Pharma Ltd — Marketing Organization

  20. May 28, 2019

    Fosun — Marketing Organization

  21. Sep 13, 2019

    ScinoPharm Taiwan — Marketing Organization

  22. Sep 13, 2019

    Noratech — Marketing Organization

  23. Sep 13, 2019

    TWi Biotechnology, Inc. — Marketing Organization

  24. Sep 13, 2019

    Salarius Pharmaceuticals, LLC — Marketing Organization

2020s

  1. Feb 18, 2020

    Ingenus Pharmaceuticals — Marketing Organization

  2. Feb 18, 2020

    Novast Labs — Marketing Organization

  3. Mar 6, 2020

    AbbVie — Marketing Organization

  4. May 8, 2020

    BPI — Marketing Organization

  5. Feb 26, 2021

    Oncopeptides AB — Marketing Organization

  6. Feb 26, 2021

    Oncopeptides AB — NDA Secondary Org

  7. May 28, 2021

    Eu Yan Sang — Marketing Organization

  8. May 28, 2021

    Meitheal — Marketing Organization

  9. Aug 14, 2023

    Delcath Systems — NDA Secondary Org

  10. May 23, 2024

    Hetero Labs Ltd — Marketing Organization

  11. Oct 29, 2024

    Avet Lifesciences — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNABINDING AGENT

    DNA binding agent

  • DNACROSS-LINKING AGENT

    DNA cross-linking agent

  • DNAINHIBITOR

    DNA inhibitor

Approval history

  • approvedPriority reviewJan 17, 1964

Chemistry & pharmacology

Loading structure…

SMILES

N[C@@H](Cc1ccc(N(CCCl)CCCl)cc1)C(=O)O
Mol. weight
305.21 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 3-(p-(bis(2-chloroethyl)amino)phenyl)-l-alanine
  • 3-(p-(bis(2-chloroethyl)amino)phenyl)-l-alanine
  • 3-p-(di(2-chloroethyl)amino)-phenyl-l-alanine
  • 3-p-(di(2-chloroethyl)amino)-phenyl-l-alanine
  • 4-(bis(2-chloroethyl)amino)-l-phenylalanine
  • 4-(bis(2-chloroethyl)amino)-l-phenylalanine
  • aikeran
  • alanine nitrogen mustard
  • alanine nitrogen mustard
  • alanine nitrogen mustard
  • alkeran
  • alkeran
  • alkeran
  • alkeran
  • cb-3025
  • cb-3025
  • cb-3025
  • l-3-(p-(bis(2-chloroethyl)amino)phenyl)alanine
  • l-3-(p-(bis(2-chloroethyl)amino)phenyl)alanine
  • levofalan
  • levofolan
  • levopholan
  • l-pam
  • l-pam
  • l-pam
  • l-phenylalanine mustard
  • l-phenylalanine mustard
  • l-phenylalanine mustard
  • l-sarcolysin
  • l-sarcolysin
  • l-sarcolysin
  • l-sarcolysine
  • l-sarcolysine
  • l-sarcolysine
  • melfalan
  • melfalan
  • melfalan
  • melfalano
  • melfalano
  • melflufen
  • melflufen
  • melflufen
  • melphalan
  • melphalan
  • melphalan
  • melphalan
  • melphalan
  • melphalan
  • melphalan
  • melphalan
  • melphalan
  • melphalan-flufenamide
  • melphalan hcl
  • melphalan hcl
  • melphalan hcl
  • melphalan hydrochloride
  • melphalan hydrochloride
  • melphalan hydrochloride
  • melphalan hydrochloride
  • melphalan hydrochloride
  • melphalan hydrochloride
  • melphalan hydrochloride
  • melphalanum
  • melphalanum
  • melphalanum
  • p-bis(beta-chloroethyl)aminophenylalanine
  • p-bis(beta-chloroethyl)aminophenylalanine
  • p-di-(2-chloroethyl)amino-l-phenylalanine
  • p-di-(2-chloroethyl)amino-l-phenylalanine
  • phenylalanine mustard
  • phenylalanine mustard
  • phenylalanine mustard
  • phenylalanine mustard
  • phenylalanine mustard
  • phenylalanine nitrogen mustard
  • phenylalanine nitrogen mustard
  • phenylalanine nitrogen mustard
  • p-l-sarcolysin
  • p-l-sarcolysin
  • p-n-bis(2-chloroethyl)amino-l-phenylalanine
  • p-n-bis(2-chloroethyl)amino-l-phenylalanine
  • p-n,n-bis(2-chloroethyl)amino-l-phenylalanine
  • p-n,n-bis(2-chloroethyl)amino-l-phenylalanine
  • sarcoclorin
  • sarcoclorin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06996119Phase 1May 25, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07228624Phase 2May 1, 2026Incyte, University of Washington
NCT07183852Phase 1Mar 31, 2026Vastra Gotaland Region
NCT06815003Phase 2Jan 8, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07276386Phase 2Dec 31, 2025Delcath Systems, University of South Florida
NCT07052370Phase 1Dec 31, 2025St. Jude Children's Hospital
NCT07257419Phase 1Dec 31, 2025St. Jude Children's Hospital
NCT06954987Phase 2Dec 18, 2025National Cancer Institute (NCI)
NCT07259161Phase 2Dec 15, 2025China Academy of Chinese Medical Sciences
NCT07025824Phase 2Sep 30, 2025Medac, Technical University of Dresden
NCT06875128Phase 2Sep 30, 2025Delcath Systems
NCT07085156Phase 2Aug 1, 2025Huazhong University of Science and Technology, Jiao Tong University, Zhejiang University
NCT06986382Phase 1/Phase 2 (Phase 2)Jul 31, 2025Stanford University
NCT07078721Phase 2Jul 20, 2025China Academy of Chinese Medical Sciences
NCT07199296Phase 2Jul 1, 2025Anhui Medical University, Central South University, Fudan University, Fujian Medical University, Jiao Tong University, Shandong University, Wenzhou Medical University
NCT06607458Phase 2May 31, 2025City of Hope National Medical Center, Delcath Systems
NCT06789861Phase 1May 23, 2025Tafalgie Therapeutics
NCT06692452Phase 2Apr 30, 2025Harvard University, Ipsen
NCT06682637Phase 2Feb 15, 2025Fondazione EMN Italy Onlus
NCT06816134Phase 2Jan 30, 2025Soochow University
Showing 20 of 728 trials
Page 1 / 37

Organizations

Research & Development (405)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government2013941992
University of Texas at HoustonAcademic/Hospital686541995
City of Hope National Medical CenterAcademic/Hospital373541994
University of WashingtonAcademic/Hospital363341996
Cornell UniversityAcademic/Hospital333331997
St. Jude Children's HospitalAcademic/Hospital222042002
CelgeneFor profit20241998
University of MinnesotaAcademic/Hospital191941998
National Institutes of Health (NIH)Government16541999
Washington University in St. LouisAcademic/Hospital161622001
Mayo ClinicAcademic/Hospital14931993
Hoosier Cancer Research NetworkAcademic/Hospital131241994
Jiao Tong UniversityAcademic/Hospital131142014
Millennium PharmaceuticalsFor profit13332004
Delcath SystemsFor profit111032004
Harvard UniversityAcademic/Hospital11631994
State University of New York, BuffaloAcademic/Hospital111141991
University of ChicagoAcademic/Hospital10732000
University of LondonAcademic/Hospital10421993
University of MarylandAcademic/Hospital10921998
405 organizations
Page 1 / 21

Marketing (47)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGMar 6, 2020
Acrotech Biopharma LLCFor profitNDA2Mar 10, 2016
ActavisFor profitMKTGDec 19, 2016
Allergan PLC (2015)For profitMKTGDec 19, 2016
AlmajectFor profitMKTGMay 17, 2019
AlvogenFor profitMKTGMar 22, 2017
AlvogenFor profitSYNMar 22, 2017
AlvogenFor profitSYNMay 17, 2019
ApotexFor profitNDA2Jan 17, 1964
ApotexFor profitMKTGJan 17, 1964
ApotexFor profitNDAJan 17, 1964
Aurobindo PharmaFor profitMKTGMar 10, 2016
Avet LifesciencesFor profitMKTGOct 29, 2024
BPIFor profitMKTGMay 8, 2020
BPIFor profitSYNMay 8, 2020
Bristol-Myers SquibbFor profitMKTGAug 22, 2016
Delcath SystemsFor profitNDA2Aug 14, 2023
Dr. Reddy's LaboratoriesFor profitMKTGDec 8, 2017
Dr. Reddy's LaboratoriesFor profitSYNDec 8, 2017
Endo PharmaceuticalsFor profitMKTGAug 22, 2016
Eu Yan SangFor profitMKTGMay 28, 2021
FosunFor profitMKTGMay 28, 2019
FreseniusFor profitMKTGDec 22, 2017
Gland Pharma LtdFor profitMKTGMay 28, 2019
Gland Pharma LtdFor profitSYNMay 28, 2019
Hetero Labs LtdFor profitMKTGMay 23, 2024
HikmaFor profitSYNOct 28, 2010
HikmaFor profitMKTGOct 28, 2010
Ingenus PharmaceuticalsFor profitMKTGFeb 18, 2020
MeithealFor profitMKTGMay 28, 2021
MylanFor profitMKTGJun 9, 2009
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGFeb 28, 2017
NoratechFor profitMKTGSep 13, 2019
Novast LabsFor profitMKTGFeb 18, 2020
Oncopeptides ABFor profitMKTGFeb 26, 2021
Oncopeptides ABFor profitNDA2Feb 26, 2021
PH HEALTHFor profitMKTGAug 22, 2016
Par PharmaceuticalsFor profitMKTGAug 22, 2016
Sagent Pharmaceuticals, Inc.For profitMKTGFeb 28, 2017
Sagent Pharmaceuticals, Inc.For profitSYNFeb 28, 2017
Salarius Pharmaceuticals, LLCFor profitMKTGSep 13, 2019
ScinoPharm TaiwanFor profitMKTGSep 13, 2019
Spectrum PharmaceuticalsFor profitNDA2Mar 10, 2016
TWi Biotechnology, Inc.For profitMKTGSep 13, 2019
US WorldMedsFor profitMKTGMay 3, 2019
US WorldMedsFor profitSYNMay 3, 2019
West-Ward PharmaceuticalFor profitMKTGOct 28, 2010