Wednesday, July 8, 2026

Drug profile · INN

doxorubicin hydrochloride

doxorubicin hydrochloride (CELDOXOME PEGYLATED LIPOSOMAL) is a dna topoisomerase ii alpha inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: unknown Antineoplastic and immunomodulating agents (L01) L01DB01
US status approved
Patents linked 0
Pipeline programs 19
News articles 0
Drug details — doxorubicin hydrochloride
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INJECTION
Patents
0
Programs
19
Data quality
0.89

Quick answer

doxorubicin hydrochloride (CELDOXOME PEGYLATED LIPOSOMAL) is a dna topoisomerase ii alpha inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN doxorubicin hydrochloride
Brand CELDOXOME PEGYLATED LIPOSOMAL
Mechanism DNA topoisomerase II alpha inhibitor
Target DNA
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INJECTION
Formulation INJECTABLE, LIPOSOMAL
ATC code L01DB01

Mechanism of action

DNA topoisomerase II alpha inhibitor

Primary target: DNA

Approval history

Authority Status Date
FDA approved
EMA unknown

Pipeline programs

  1. ALKS 4230-007 Phase 3 · Createrna Science and · Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Pr
  2. C25003 Phase 3 · Takeda · Advanced Classical Hodgkin Lymphoma
  3. CA073-1003 Phase 3 · Celgene · Relapsed/Refractory Follicular Lymphoma
  4. CA073-1020 Phase 3 · Celgene · High-risk Large B-cell Lymphoma
  5. CBYL719K12301 Phase 3 · Novartis India · Platinum-resistant or refractory, high-grade serous ovarian
  6. D8991C00001 Phase 3 · AstraZeneca · Advanced Platinum-resistant Epithelial Ovarian Cancer
  7. DS6000-109 Phase 3 · Daiichi Sankyo US · Platinum-resistant, high-grade serous ovarian cancer (OVC),h
  8. Doxorubicin Phase 3 · Takeda · Hodgkin Lymphoma

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 doxorubicin hydrochloride?

doxorubicin hydrochloride (CELDOXOME PEGYLATED LIPOSOMAL) is a dna topoisomerase ii alpha inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for doxorubicin hydrochloride?

CELDOXOME PEGYLATED LIPOSOMAL is a marketed brand name for doxorubicin hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of doxorubicin hydrochloride?

doxorubicin hydrochloride 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.