Wednesday, July 8, 2026

Drug profile · INN

thiotepa

thiotepa (TEPADINA) is a dna inhibitor. Associated with Teva Pharma GmbH. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved Antineoplastic and immunomodulating agents (L01) L01AC01
US status approved
Patents linked 0
Pipeline programs 11
News articles 0
Drug details — thiotepa
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INJECTION
Patents
0
Programs
11
Data quality
0.89

Quick answer

thiotepa (TEPADINA) is a dna inhibitor. Associated with Teva Pharma GmbH. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN thiotepa
Brand TEPADINA
Mechanism DNA inhibitor
Target DNA
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INJECTION
Formulation POWDER
ATC code L01AC01

Mechanism of action

DNA inhibitor

Primary target: DNA

Approval history

Authority Status Date
FDA approved
EMA approved

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. MDS0519 Phase 3 · Telethon Foundation · Higher-risk-myelodysplastic syndromes
  4. APHP190648 Phase 2 · PARItec · Myelofibrosis
  5. APLOaß-NB Phase 2 · Istituto Gentili Italia · Patient affected by high risk Neuroblastoma relapsed or in p
  6. IC 2009-04 Phase 2 · George Institute for · Retinoblastoma
  7. IIT2025094 Phase 2 · Chinese Academy of · CML,Blast Phase
  8. Ommaya 02 Phase 2 · First People's Hospital · Leptomeningeal Metastasis of HER2-positive Breast Cancer

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 thiotepa?

thiotepa (TEPADINA) is a dna inhibitor. Associated with Teva Pharma GmbH. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for thiotepa?

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

What is the US approval status of thiotepa?

thiotepa 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.