Wednesday, July 8, 2026

Drug profile · INN

dinutuximab

dinutuximab (UNITUXIN) is a disialoganglioside gd2 binding agent. Associated with United Therapeutics Europe Ltd. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved EMA: withdrawn Antineoplastic and immunomodulating agents (L01) L01FX06
US status approved
Patents linked 20
Pipeline programs 4
News articles 0
Drug details — dinutuximab
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INTRAVENOUS
Patents
20
Programs
4
Data quality
0.89

Quick answer

dinutuximab (UNITUXIN) is a disialoganglioside gd2 binding agent. Associated with United Therapeutics Europe Ltd. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN dinutuximab
Brand UNITUXIN
Mechanism Disialoganglioside GD2 binding agent
Target Disialoganglioside GD2
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INTRAVENOUS
Formulation INJECTABLE
ATC code L01FX06

Mechanism of action

Disialoganglioside GD2 binding agent

Primary target: Disialoganglioside GD2

Approval history

Authority Status Date
FDA approved
EMA withdrawn

Pipeline programs

  1. Dinutuximab Phase 3 · United Therapeutics Europe · Small Cell Lung Cancer
  2. Dinutuximab Phase 2 · Shanghai Medical College · High Risk Neuroblastoma
  3. Dinutuximab Phase 2 · United Therapeutics Europe · Ganglioneuroblastoma
  4. Dinutuximab Phase 1 · United Therapeutics Europe · Neuroblastoma

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 12383500

    Nanoliposome compositions and methods of using the same

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12383618

    Expression vector delivery system and use thereof for inducing an immune response

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12383554

    Compositions and methods to protect mammalian tissue against cold and other metabolic stresses

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12384820

    Griffithsin mutants

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 12350274

    Nucleotide analogs

    Expires Mon Jul 03 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 12343432

    Encapsulated probiotic

    Expires Mon Jun 26 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 12336974

    Methods and compositions for preventing and treating auditory dysfunctions

    Expires Mon Jun 19 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 12325688

    Gingerenone A prodrugs as sensotherapeutics and methods of use

    Expires Mon Jun 05 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 12298315

    Systems and methods to identify and treat subjects at risk for obstetrical complications

    Expires Mon May 08 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 12286657

    Methods and compositions

    Expires Mon Apr 24 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 12281060

    Remodilins for airway remodeling and organ fibrosis

    Expires Mon Apr 17 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 12281336

    Chikungunya virus (CHIKV) virus-like particles (VLPS) comprising the C, E1, and E2 structural proteins

    Expires Mon Apr 17 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 12275758

    Prefusion RSV F proteins and their use

    Expires Mon Apr 10 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 12269803

    Krüppel-like factor 15 (KLF15) small molecule agonists in kidney disease

    Expires Mon Apr 03 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 12268749

    Cell-penetrating peptides

    Expires Mon Apr 03 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 12239654

    Compounds and methods for treating neurological and cardiovascular conditions

    Expires Mon Feb 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 12226423

    Compositions comprising 5-cholesten-3, 25-diol, 3-sulfate (25HC3S) or pharmaceutically acceptable salt thereof and at least one cyclic oligosaccharide

    Expires Mon Feb 13 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 12215164

    Immunotoxins with albumin binding domain

    Expires Mon Jan 30 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 12214031

    Mannheimia haemolytica vector

    Expires Mon Jan 30 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 12210017

    Peptides representing epitopes from filoviruses

    Expires Mon Jan 23 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is dinutuximab?

dinutuximab (UNITUXIN) is a disialoganglioside gd2 binding agent. Associated with United Therapeutics Europe Ltd. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for dinutuximab?

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

What is the US approval status of dinutuximab?

dinutuximab 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.