Friday, July 10, 2026

Drug profile · INN

cytarabine

cytarabine (PFIZER AUSTRALIA PTY LTD) is a dna polymerase (alpha/delta/epsilon) inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: withdrawn TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01BC01
US status approved
Patents linked 7
Pipeline programs 57
News articles 0
Drug details — cytarabine
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INJECTION
Patents
7
Programs
57
Data quality
0.89

Quick answer

cytarabine (PFIZER AUSTRALIA PTY LTD) is a dna polymerase (alpha/delta/epsilon) inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN cytarabine
Brand PFIZER AUSTRALIA PTY LTD
Mechanism DNA polymerase (alpha/delta/epsilon) inhibitor
Target DNA
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INJECTION
Formulation INJECTABLE, LIPOSOMAL
ATC code L01BC01

Mechanism of action

DNA polymerase (alpha/delta/epsilon) inhibitor

Primary target: DNA

Approval history

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EMA withdrawn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

Pipeline programs

  1. 042011 Phase 3 · George Institute for · Langerhans Cell Histiocytosis
  2. 09 Phase 3 · First People's Hospital · Acute Myeloid Leukaemia
  3. 20190360 Phase 3 · Amgen · Newly diagnosed Philadelphia-negative B-cell precursor Acute
  4. ALL2820 Phase 3 · Telethon Foundation · Adult Philadelphia Chromosome-Positive Acute Lymphoblastic L
  5. CCTL019H2301 Phase 3 · Novartis India · Adult patients with relapsed or refractory aggressive B-cell
  6. Cytarabine Phase 3 · HOFFMANN-LA ROCHE · Leukemia, Myeloid, Acute
  7. Cytarabine Phase 3 · Chinese Academy of · AML
  8. Cytarabine Phase 3 · Jazz Pharmaceuticals Ireland · Acute Myeloid Leukemia

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)
  1. US 11975081

    Bifunctional chelators and conjugates

    Expires Mon May 02 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11964948

    Bifunctional chelators and conjugates

    Expires Mon Apr 18 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 9790573

    Method for purification of 225AC from irradiated 226RA-targets

    Expires Mon Oct 12 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 9603954

    Methods for generating radioimmunoconjugates

    Expires Mon Mar 23 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 9534277

    Method for purification of 225AC from irradiated 226RA-targets

    Expires Mon Dec 29 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 8450337

    Methods of treating skin disorders with caffeic acid analogs

    Expires Mon May 23 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 8349391

    Radium target and method for producing it

    Expires Mon Jan 03 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is cytarabine?

cytarabine (PFIZER AUSTRALIA PTY LTD) is a dna polymerase (alpha/delta/epsilon) inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for cytarabine?

PFIZER AUSTRALIA PTY LTD is a marketed brand name for cytarabine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of cytarabine?

cytarabine 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.