Selpercatinib
Also known as Retevmo
ELI LILLY & Co LLY · Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
Approved
NDA213246,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ELI LILLY & Co LLY Source: Company record for ELI LILLY & Co (opens in a new tab)
- Indications
- Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 213246 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 213246 (opens in a new tab)
- NDA 218160 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 218160 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 17 Feb 20202 linked trials
- Filed Completed
- Approved Current stageFirst approval 8 May 2020
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 Selpercatinib. Editors add each one with its source.
Filed application
No filed application is on record for Selpercatinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Selpercatinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04819100ClinicalTrials.gov record for NCT04819100 (opens in a new tab)LIBRETTO-432 | A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) | Phase 3 | Active, not recruiting | 152 (estimated) | 12 Jan 2026 (actual) | No |
Publications listing LIBRETTO-432 (2), 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. | ||||||
| NCT04194944ClinicalTrials.gov record for NCT04194944 (opens in a new tab)LIBRETTO-431 | A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer | Phase 3 | Active, not recruiting | 261 (actual) | 1 May 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04194944 (opens in a new tab) |
Posted results on ClinicalTrials.gov for LIBRETTO-431
Serious adverse events (Baseline Up to 38 Months): Selpercatinib (TRT A) 55 of 158; Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) 23 of 98 Source: ClinicalTrials.gov results for NCT04194944 (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 LIBRETTO-431 (5), 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
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)
Authorised
Retsevmo (EMEA/H/C/005375)
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung;Thyroid Neoplasms;Cancer
- Marketing authorisation holder
- Eli Lilly Nederland B.V.
- Active substance (INN)
- selpercatinib
- ATC code
- L01EX22
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Retsevmo (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 213246 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04819100 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04194944 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA213246 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA218160 (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.