Wednesday, July 8, 2026
🇺🇸 FDA

Drug profile · INN

fludarabine phosphate

FLUDARABINE PHOSPHATE

fludarabine phosphate (FLUDARABINE PHOSPHATE) is a dna polymerase (alpha/delta/epsilon) inhibitor. Route of administration: injection. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 13
Pipeline programs 60
News articles 0
Drug details — fludarabine phosphate
US status
approved
Class
—
Route
INJECTION
Patents
13
Programs
60
Data quality
0.84
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Quick answer

fludarabine phosphate (FLUDARABINE PHOSPHATE) is a dna polymerase (alpha/delta/epsilon) inhibitor. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN fludarabine phosphate
Brand FLUDARABINE PHOSPHATE
Mechanism DNA polymerase (alpha/delta/epsilon) inhibitor
Target DNA polymerase (alpha/delta/epsilon)
Route INJECTION
Formulation INJECTABLE

Mechanism of action

DNA polymerase (alpha/delta/epsilon) inhibitor

Primary target: DNA polymerase (alpha/delta/epsilon)

Approval history

Authority Status Date
FDA approved —

Pipeline programs

Search pipeline
  1. 042011 Phase 3 · George Institute for · Langerhans Cell Histiocytosis
  2. 68284528MMY3002 Phase 3 · Janssen-Cilag International N.V · Relapsed and Lenalidomide-Refractory Multiple Myeloma
  3. 68284528MMY3004 Phase 3 · Janssen-Cilag International N.V · Multiple Myeloma
  4. ACE-CL-311 (AMPLIFY) Phase 3 · Anaxis Pharma · Previously untreated Chronic Lymphocytic Leukemia Without de
  5. ALL SCTped FORUM Phase 3 · George Institute for · Acute Lymphoblastic Leukaemia
  6. APG2575CC301 Phase 3 · Anaxis Pharma · Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocyt
  7. CA088-1007 Phase 3 · Celgene · Relapsed or Refractory and Lenalidomide exposed Multiple Mye
  8. CCTL019H2301 Phase 3 · Novartis India · Adult patients with relapsed or refractory aggressive B-cell

Related & competitor drugs

Browse all drugs
  1. gemcitabine hydrochloride DNA polymerase (alpha/delta/epsilon) inhibitor

Related patents

Browse patents

  1. US 12247226

    Cellular reprogramming using temporal and transient plasmid vector expression system

    Expires Mon Mar 06 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. US 11135244

    Stem cell culture media and methods of enhancing cell survival

    Expires Mon Sep 30 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 11052118

    Enhanced stem cell composition

    Expires Mon Jul 01 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 10980838

    Methods of treating ischemia

    Expires Mon Apr 15 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 10851412

    Cell potency assay for therapeutic potential

    Expires Mon Nov 26 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

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  6. US 10172888

    Enhanced stem cell composition

    Expires Mon Jan 03 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. US 10111907

    Methods of treating ischemia

    Expires Mon Oct 25 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 9943545

    Stem cell culture media and methods of enhancing cell survival

    Expires Mon Apr 12 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 9873722

    Wnt compositions and therapeutic uses of such compositions

    Expires Mon Jan 18 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. US 9452186

    Enhanced stem cell composition

    Expires Mon Sep 22 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. US 9403885

    Wnt compositions and therapeutic uses of such compositions

    Expires Mon Jul 28 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  12. US 9370510

    Small molecule compounds to treat hearing loss

    Expires Mon Jun 16 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  13. US 6103269

    Solid bodies containing active substances and a structure consisting of hydrophilic macromolecules, plus a method of producing such bodies

    Expires Mon Aug 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is fludarabine phosphate?

fludarabine phosphate (FLUDARABINE PHOSPHATE) is a dna polymerase (alpha/delta/epsilon) inhibitor. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for fludarabine phosphate?

FLUDARABINE PHOSPHATE is a marketed brand name for fludarabine phosphate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of fludarabine phosphate?

fludarabine phosphate 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.

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