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Drug ReportsMelphalan
Alkeran, Phelinun(melphalan)
Alkeran, Evomela, Hepzato, Ivra, Melphalan, 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.
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FDA Novel Drug Approvals 2021
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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, Ivra, Melphalan (discontinued: Alkeran, Melphalan)
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
IVRAApotexN-217110 RX2023-08-18
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
evomelaNew Drug Application2023-06-13
hepzato kitNew Drug Application2025-05-19
ivraNew Drug Application2025-09-04
melphalanANDA2025-05-05
melphalan hydrochlorideANDA2025-07-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
ovarian neoplasmsEFO_0003893D010051C56
multiple myeloma—D009101C90.0
neuroblastomaEFO_0000621D009447—
rhabdomyosarcoma—D012208—
Agency Specific
FDA
EMA
Expiration
Code
MELPHALAN HYDROCHLORIDE, HEPZATO, DELCATH SYSTEMS INC
2030-08-14ODE-438
2026-08-14NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Melphalan Hydrochloride, Melphalan Hydrochloride, Apotex
105375202036-06-29DP
Melphalan Hydrochloride, Hepzato, Delcath Systems Inc
97073312034-09-17DP
93145612034-02-07DP
101953342033-01-16DP
110838312032-12-30DP
118332862032-12-30DP
100989972032-11-07DP
103692642032-11-07DP
105690042032-11-07U-3680, U-3683
112415222032-11-07DP
116335282032-11-07U-3675
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
978 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101—C90.0—2———2
Plasma cell neoplasmsD054219———1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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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—
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Structure (InChI/SMILES or Protein Sequence)
N[C@@H](Cc1ccc(N(CCCl)CCCl)cc1)C(=O)O
Identifiers
PDB—
CAS-ID148-82-3
RxCUI—
ChEMBL IDCHEMBL852
ChEBI ID28876
PubChem CID460612
DrugBankDB01042
UNII IDQ41OR9510P (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Alkeran – Celgene
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Evomela – Casi Pharmaceuticals
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Evomela – Ligand Pharmaceuticals
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Evomela – Spectrum Pharmaceuticals
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Tabular view
Estimated US medical usage
Melphalan
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 22,785 documents
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Safety
Black-box Warning
Black-box warning for: Evomela, Hepzato kit, Ivra, Melphalan hydrochloride
Adverse Events
Top Adverse Reactions
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24,290 adverse events reported
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