Wednesday, July 8, 2026

Drug profile · INN

busulfan

busulfan (MYLERAN) is a dna inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01AB01
US status approved
Patents linked 20
Pipeline programs 21
News articles 0
Drug details — busulfan
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INJECTION
Patents
20
Programs
21
Data quality
0.89

Quick answer

busulfan (MYLERAN) is a dna inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN busulfan
Brand MYLERAN
Mechanism DNA inhibitor
Target DNA
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INJECTION
Formulation INJECTABLE
ATC code L01AB01

Mechanism of action

DNA inhibitor

Primary target: DNA

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. 2019/2894 Phase 3 · George Institute for · Patients with High Risk Neuroblastoma
  2. ALL SCTped FORUM Phase 3 · George Institute for · Acute Lymphoblastic Leukaemia
  3. Busulfan (BU) Phase 3 · First People's Hospital · Primary Central Nervous System Lymphoma
  4. CTX001-111 Phase 3 · Vertex Pharmaceuticals (Australia) · Transfusion-dependent β-thalassemia (TDT)
  5. DAUNORUBICIN for Favorable-intermediate-risk Acu… Phase 3 · Telethon Foundation · Favorable-intermediate-risk Acute Myeloid Leukemia
  6. FEDR-MF-002 Phase 3 · Celgene · Primary myelofibrosis, post-polycythemia vera myelofibrosis
  7. MDS0519 Phase 3 · Telethon Foundation · Higher-risk-myelodysplastic syndromes
  8. MK-3543-006 Phase 3 · MSD Merck Sharp · Essential Thrombocythemia patients who have an inadequate re

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)
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Frequently asked questions

What is busulfan?

busulfan (MYLERAN) is a dna inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for busulfan?

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

What is the US approval status of busulfan?

busulfan 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.