Wednesday, July 8, 2026

Drug profile · INN

pralatrexate

pralatrexate (FOLOTYN) is a dihydrofolate reductase inhibitor. Associated with Mundipharma Pty Limited. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: refused TGA: approved Antineoplastic and immunomodulating agents (L01) L01BA05
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — pralatrexate
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INJECTION
Patents
0
Programs
2
Data quality
0.89

Quick answer

pralatrexate (FOLOTYN) is a dihydrofolate reductase inhibitor. Associated with Mundipharma Pty Limited. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN pralatrexate
Brand FOLOTYN
Mechanism Dihydrofolate reductase inhibitor
Target Dihydrofolate reductase
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INJECTION
Formulation INJECTABLE
ATC code L01BA05

Mechanism of action

Dihydrofolate reductase inhibitor

Primary target: Dihydrofolate reductase

Approval history

Authority Status Date
FDA approved
EMA refused
TGA approved

Pipeline programs

  1. SPI-BEL-301 Phase 3 · Anaxis Pharma · Peripheral T-Cell Lymphoma
  2. pralatrexate Phase 3 · Chinese Academy of · Refractory Peripheral T-Cell Lymphoma

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. aminosalicylate sodium Dihydrofolate reductase inhibitor
  3. anagrelide Antineoplastic and immunomodulating agents (L01)
  4. apremilast Antineoplastic and immunomodulating agents (L04)
  5. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  6. axitinib Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is pralatrexate?

pralatrexate (FOLOTYN) is a dihydrofolate reductase inhibitor. Associated with Mundipharma Pty Limited. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for pralatrexate?

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

What is the US approval status of pralatrexate?

pralatrexate 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.