Wednesday, July 8, 2026

Drug profile · INN

cladribine

cladribine (CLADRITAB) is a dna inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04AA40
US status approved
Patents linked 0
Pipeline programs 8
News articles 0
Drug details — cladribine
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
INJECTION
Patents
0
Programs
8
Data quality
0.84

Quick answer

cladribine (CLADRITAB) is a dna inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN cladribine
Brand CLADRITAB
Mechanism DNA inhibitor
Target DNA
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route INJECTION
Formulation INJECTABLE
ATC code L04AA40

Mechanism of action

DNA inhibitor

Primary target: DNA

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. 042011 Phase 3 · George Institute for · Langerhans Cell Histiocytosis
  2. Cladribine (MAVENCLAD®) Phase 3 · United Therapeutics Europe · Advanced Multiple Sclerosis
  3. IRST204.07 Phase 3 · Istituto Gentili Italia · Acute myeloid leukemia
  4. MS700568_0183 Phase 3 · MSD Merck Sharp · Generalized Myasthenia Gravis
  5. cladribine Phase 2 · Ultragenyx UK · Cholangitis, Sclerosing
  6. Bioequivalence of Cladribine 10 mg from two different products Phase 1 · Anaxis Pharma · No therapeutic indication in the current trial with healthy
  7. CEREAL-IPC 2016-010 Phase 1 · George Institute for · Acute leukemia and myelodysplastic syndromes
  8. CPO25001 Phase 1 · Anaxis Pharma · No therapeutic indication in the current trial with healthy

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 cladribine?

cladribine (CLADRITAB) is a dna inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for cladribine?

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

What is the US approval status of cladribine?

cladribine 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.