Skip to content
Alkeran, Phelinun(melphalan)
Alkeran, Evomela, Phelinun (melphalan) is a small molecule pharmaceutical. Melphalan was first approved as Alkeran on 1982-01-01. It is used to treat breast neoplasms, multiple myeloma, neuroblastoma, ovarian neoplasms, and rhabdomyosarcoma in the USA. It has been approved in Europe to treat hematopoietic stem cell transplantation, hodgkin disease, multiple myeloma, myeloid leukemia acute, and neuroblastoma amongst others.
Download report
Favorite
FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
immune system diseasesD007154
therapeuticsD013812
operative surgical proceduresD013514
Trade Name
FDA
EMA
Evomela (generic drugs available since 2009-06-09, discontinued: Alkeran)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Melphalan
Tradename
Company
Number
Date
Products
ALKERANApotexN-014691 DISCN1982-01-01
1 products, RLD
Hide discontinued
Melphalan hydrochloride
Tradename
Company
Number
Date
Products
EVOMELAAcrotech BiopharmaN-207155 RX2016-03-10
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
alkeranNew Drug Application2022-12-05
evomelaNew Drug Application2022-04-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
multiple myeloma—D009101C90.0
neuroblastomaEFO_0000621D009447—
ovarian neoplasmsEFO_0003893D010051C56
rhabdomyosarcoma—D012208—
Agency Specific
FDA
EMA
Expiration
Code
MELPHALAN HYDROCHLORIDE, EVOMELA, ACROTECH BIOPHARMA
2023-03-10ODE-110
Patent Expiration
Patent
Expires
Flag
FDA Information
Melphalan Hydrochloride, Evomela, Acrotech Biopharma
100408722034-01-30DP
94935822033-02-27DP
109401282030-06-14DPU-3086
108641832030-05-28DP
110203632030-05-28DP
84100772029-03-13DP
92000882029-03-13DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01A: Alkylating agents
— L01AA: Nitrogen mustard analogues
— L01AA03: Melphalan
— L01AA10: Melphalan flufenamide
HCPCS
Code
Description
J8600
Melphalan; oral, 2 mg
J9245
Injection, melphalan hydrochloride, not otherwise specified, 50 mg
J9246
Injection, melphalan (evomela), 1 mg
J9247
Injection, melphalan flufenamide, 1mg
Clinical
Clinical Trials
668 clinical trials
View more details
Mock data
Subscribe for the real data
Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.05911933312190
Non-hodgkin lymphomaD008228C85.92144—1456
Large b-cell lymphoma diffuseD016403C83.361141323
Burkitt lymphomaD002051C83.724—139
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.9287112—9109
Myelodysplastic syndromesD009190D4626575—680
LeukemiaD007938C9523455—767
Plasma cell neoplasmsD054219144411—262
Myeloid leukemia acuteD015470C92.017425—561
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.010352—447
NeuroblastomaD009447EFO_0000621142011—445
NeoplasmsD009369C8013133—226
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_00003406231—226
RetinoblastomaD012175873—521
Show 19 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hodgkin diseaseD006689C811229——640
B-cell chronic lymphocytic leukemiaD015451C91.1520——325
Hematologic neoplasmsD019337812——219
Graft vs host diseaseD006086D89.81613——117
Primary myelofibrosisD055728D47.449——215
Follicular lymphomaD008224C8249——312
Myelomonocytic leukemia chronicD015477C93.138——111
Aplastic anemiaD000741HP_0001915D61.936——210
Myelomonocytic leukemia juvenileD054429C93.318——19
Plasma cell leukemiaD007952C90.146——19
Show 122 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wilms tumorD0093962———13
EpendymomaD0048062————2
Choroid plexus neoplasmsD016545EFO_00072062————2
PhenylketonuriasD010661E70.01———12
Fallopian tube neoplasmsD0051852————2
Neuroectodermal tumorsD0175991———12
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A1————1
Rhabdoid tumorD0183351————1
Large cell carcinomaD0182871————1
Neuroepithelial neoplasmsD0183021————1
Show 10 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intraocular lymphomaD064090————22
Basal cell carcinomaD002280————11
Skin neoplasmsD012878EFO_0004198C44————11
Squamous cell carcinomaD002294————11
Eccrine porocarcinomaD057090————11
Aids-related lymphomaD016483EFO_1001365————11
Leukemia myeloid chronic atypical bcr-abl negativeD054438C92.2————11
Neutrophilic leukemia chronicD015467D47.1————11
HemoglobinopathiesD006453D58.2————11
StomatitisD013280EFO_1001904K12.1————11
Show 3 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameMELPHALAN
INNmelphalan
Description
Melphalan is a phenylalanine derivative comprising L-phenylalanine having [bis(2-chloroethyl)amino group at the 4-position on the phenyl ring. It has a role as an antineoplastic agent, a carcinogenic agent, an alkylating agent, an immunosuppressive agent and a drug allergen. It is an organochlorine compound, a nitrogen mustard, a L-phenylalanine derivative and a non-proteinogenic L-alpha-amino acid.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
N[C@@H](Cc1ccc(N(CCCl)CCCl)cc1)C(=O)O
Identifiers
PDB—
CAS-ID148-82-3
RxCUI6718
ChEMBL IDCHEMBL852
ChEBI ID28876
PubChem CID460612
DrugBankDB01042
UNII IDQ41OR9510P (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Alkeran - Celgene
$
€
£
₣
Mock data
Subscribe for the real data
Mock data
Subscribe for the real data
Evomela - Casi Pharmaceuticals
$
€
£
₣
Mock data
Subscribe for the real data
Mock data
Subscribe for the real data
Evomela - Ligand Pharmaceuticals
$
€
£
₣
Mock data
Subscribe for the real data
Mock data
Subscribe for the real data
Evomela - Spectrum Pharmaceuticals
$
€
£
₣
Mock data
Subscribe for the real data
Mock data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Additional graphs summarizing 17,983 documents
View more details
Safety
Black-box Warning
Black-box warning for: Alkeran, Evomela
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
2,566 adverse events reported
View more details