Seladelpar
Also known as Livdelzi, Seladelpar lysine
GILEAD SCIENCES, INC. GILD · Primary Biliary Cholangitis; Primary Biliary Cirrhosis
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
5
From ClinicalTrials.gov
Latest FDA action
Approved
NDA217899,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- GILEAD SCIENCES, INC. GILD Source: Company record for GILEAD SCIENCES, INC. (opens in a new tab)
- Indications
- Primary Biliary Cholangitis; Primary Biliary Cirrhosis Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 217899 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 217899 (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 12 Dec 20175 linked trials
- Filed Completed
- Approved Current stageFirst approval 14 Aug 2024
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 Seladelpar. Editors add each one with its source.
Filed application
No filed application is on record for Seladelpar. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Seladelpar.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06051617ClinicalTrials.gov record for NCT06051617 (opens in a new tab)AFFIRM | Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis | Phase 3 | Recruiting | 402 (estimated) | Aug 2030 (estimated) | No |
| NCT06060665ClinicalTrials.gov record for NCT06060665 (opens in a new tab)IDEAL | Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) | Phase 3 | Completed | 96 (actual) | 6 May 2026 (actual) | No |
| NCT04620733ClinicalTrials.gov record for NCT04620733 (opens in a new tab) | RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) | Phase 3 | Completed | 193 (actual) | 11 Aug 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04620733 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT04620733
Serious adverse events (All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)): Placebo 4 of 65; Seladelpar 9 of 128 Source: ClinicalTrials.gov results for NCT04620733 (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 NCT04620733 (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. | ||||||
| NCT03602560ClinicalTrials.gov record for NCT03602560 (opens in a new tab) | ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) | Phase 3 | Completed | 265 (actual) | 16 Feb 2020 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03602560 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03602560
Serious adverse events (An AE will be recorded any time after the time of signed ICF and captured until this double-blinded study's last study visit, up to 1 year.): Seladelpar 5/10 mg 3 of 89; Seladelpar 10 mg 1 of 89; Placebo 3 of 87 Source: ClinicalTrials.gov results for NCT03602560 (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 NCT03602560 (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. | ||||||
| NCT03301506ClinicalTrials.gov record for NCT03301506 (opens in a new tab) | Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC) | Phase 3 | Active, not recruiting | 340 (estimated) | Nov 2028 (estimated) | No |
Publications listing NCT03301506 (4), 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 |
|---|---|---|---|---|---|
| NDA217899Action letter for NDA217899 (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)
AuthorisedOrphan medicinePRIMEConditional
Lyvdelzi (previously Seladelpar Gilead) (EMEA/H/C/004692)
- Authorised
- Not given
- Therapeutic area
- Liver Cirrhosis, Biliary
- Marketing authorisation holder
- Gilead Sciences Ireland Unlimited Company
- Active substance (INN)
- seladelpar lysine dihydrate
- ATC code
- A05AX07
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Lyvdelzi (previously Seladelpar Gilead) (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 217899 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06051617 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06060665 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04620733 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03602560 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03301506 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA217899 (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.