Dinutuximab
Also known as Unituxin
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
BLA125516,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- UNITED THERAPEUTICS Corp UTHR Source: Company record for UNITED THERAPEUTICS Corp (opens in a new tab)
- Indication
- Small Cell Lung Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 125516 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 125516 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 1 Jun 20171 linked trial
- Phase 3 CompletedFirst trial start 1 Jun 20171 linked trial
- Filed Completed
- Approved Current stageFirst approval 10 Mar 2015
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Dinutuximab. Editors add each one with its source.
Filed application
No filed application is on record for Dinutuximab. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Dinutuximab.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT03098030ClinicalTrials.gov record for NCT03098030 (opens in a new tab) | Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer | Phase 2/3 | Completed | 483 (actual) | 27 Jan 2020 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03098030 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03098030 Serious adverse events (Adverse events (AEs) were collected for all enrolled subjects beginning with first dose of study medication. Serious adverse events (and AEs based on local regulations) were to be collected starting on the day of written informed consent. In addition to reporting while on study therapy, adverse events were required to be reported through 30 days after the last dose of study therapy.): Part 1: Dinutuximab + Irinotecan 5 of 12; Part 2: Dinutuximab + Irinotecan 74 of 183; Part 2: Irinotecan 76 of 187; Part 2: Topotecan 39 of 88 Source: ClinicalTrials.gov results for NCT03098030 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT03098030 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| BLA125516Action letter for BLA125516 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Withdrawn
Unituxin (EMEA/H/C/002800)
- Authorised
- Therapeutic area
- Neuroblastoma
- Marketing authorisation holder
- United Therapeutics Europe Ltd
- Active substance (INN)
- dinutuximab
- ATC code
- L01FX06
- Latest EMA decision
- Withdrawn
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Unituxin (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 125516 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT03098030 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA125516 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.