Wednesday, July 8, 2026

Drug profile · INN

melphalan

melphalan (ALKERAN) is a dna inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L01) L01AA03
US status approved
Patents linked 0
Pipeline programs 15
News articles 1
Drug details — melphalan
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
15
Data quality
0.84

Quick answer

melphalan (ALKERAN) is a dna inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN melphalan
Brand ALKERAN
Mechanism DNA inhibitor
Target DNA
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01AA03

Mechanism of action

DNA inhibitor

Primary target: DNA

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Recent coverage

Pipeline programs

  1. 042011 Phase 3 · George Institute for · Langerhans Cell Histiocytosis
  2. 2019/2894 Phase 3 · George Institute for · Patients with High Risk Neuroblastoma
  3. ALL2820 Phase 3 · Telethon Foundation · Adult Philadelphia Chromosome-Positive Acute Lymphoblastic L
  4. CCTL019H2301 Phase 3 · Novartis India · Adult patients with relapsed or refractory aggressive B-cell
  5. Venetoclax in combination with fludarabine and melphalan Phase 3 · First People's Hospital · Venentoclax
  6. IC 2011-05 Phase 2 · George Institute for · Retinoblastoma
  7. IC 2019-05 Phase 2 · George Institute for · Ocular conservative treatment for retinoblastoma
  8. IIT2025094 Phase 2 · Chinese Academy of · CML,Blast Phase

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. acyclovir Human herpesvirus 1 DNA polymerase inhibitor
  3. acyclovir sodium Human herpesvirus 1 DNA polymerase inhibitor
  4. anagrelide Antineoplastic and immunomodulating agents (L01)
  5. apremilast Antineoplastic and immunomodulating agents (L04)
  6. arsenic trioxide Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is melphalan?

melphalan (ALKERAN) is a dna inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for melphalan?

ALKERAN is a marketed brand name for melphalan. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of melphalan?

melphalan has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.