Ireland
--:--IST
Priya Life Science Compound trial record
Compound · clinical trials

Setidegrasib clinical trials

Also listed in trial records as ASP3082
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 5 trials in our USA, China, France, Japan, Spain, South Korea, UK, Germany, Poland, Brazil, Taiwan and Israel registers that name Setidegrasib as an intervention. Synced 10 Nov 2026
5Current trials
4Recruiting now
3Lead sponsors
12Country registers
At a glance

Setidegrasib is named as an intervention in 5 current clinical trials in our USA, China, France, Japan, Spain, South Korea, UK, Germany, Poland, Brazil, Taiwan and Israel registers. 4 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Astellas Pharma Global Development, Inc (3). The most-studied condition is Pancreatic Cancer. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.

How Setidegrasib works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • Malignant pancreatic neoplasmPhase 3
  • Non-small cell lung carcinomaPhase 3
  • Pancreatic adenocarcinomaPhase 3
  • Pancreatic neoplasmPhase 3
  • Pancreatic ductal adenocarcinomaPhase 2

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL6068173, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Setidegrasib

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Setidegrasib

ChEMBL
CHEMBL6068173
DrugBank
DB21670
PubChem CID
164875418
CAS number
2821793-99-9
FDA UNII
3NQ4ME292X
Wikidata
Q140562002
Wikipedia
Setidegrasib

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting480%
  • Active, closed120%

Trials by phase

  • Phase 3240%
  • Phase 1240%
  • Phase 2120%
01

Clinical trials of Setidegrasib

5 trials
StudyPhaseStatusLead sponsorRegisters
A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
NCT07409272 · Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
Phase 3 Recruiting Astellas Pharma Global Development, Inc UK, USA, China, Germany, France, Spain, Poland, Brazil, Japan, South Korea, Taiwan
A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation
NCT07566052 · Non-small Cell Lung Cancer (NSCLC)
Phase 3 Recruiting Astellas Pharma Global Development, Inc USA, China, Japan
Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance
NCT07483983 · ClinicalTrials.gov ↗ · Metastatic/Locally Advanced Non-Small-Cell Lung Cancer, Metastatic/Locally Pancreatic Ductal Adenocarcinoma
Phase 2 Recruiting Gustave Roussy, Cancer Campus, Grand Paris France
A Study of ASP3082 in Adults With Advanced Solid Tumors
NCT05382559 · Solid Tumor
Phase 1 Recruiting Astellas Pharma Inc USA, China, France, Spain, Japan, South Korea, Israel
A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
NCT07395024 · Healthy Volunteer
Phase 1 Active, closed Astellas Pharma Global Development, Inc USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Setidegrasib in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Setidegrasib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
A Randomized, Open-label, Phase 3 Study of Setidegrasib (ASP3082) versus Docetaxel in Participants with KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on or After Platinum-based Chemotherapy and Checkpoint Inhibitor Therapy (CPI)
2025-524079-22-00 · CTIS ↗ · Neoplasms
Phase 3 Authorised Astellas Pharma Global Development Inc Italy, Poland, Spain + 3 more
03

Conditions studied with Setidegrasib

8 conditions
Pancreatic Cancer1Metastatic Pancreatic Cancer1Metastatic Pancreatic Adenocarcinoma1Solid Tumor1Non-small Cell Lung Cancer (NSCLC)1Healthy Volunteer1Metastatic/Locally Advanced Non-Small-Cell Lung Cancer1Metastatic/Locally Pancreatic Ductal Adenocarcinoma1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Astellas Pharma Global Development, Inc3
Astellas Pharma Inc1
Gustave Roussy, Cancer Campus, Grand Paris1
05

By country register

RegisterTrialsRecruiting
Clinical trials in USA43
Clinical trials in China33
Clinical trials in France33
Clinical trials in Japan33
Clinical trials in Spain22
Clinical trials in South Korea22
Clinical trials in UK11
Clinical trials in Germany11
Clinical trials in Poland11
Clinical trials in Brazil11
Clinical trials in Taiwan11
Clinical trials in Israel11
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

06

Related compounds

07

Questions about Setidegrasib trials

How many clinical trials are testing Setidegrasib?

5 current trials in our USA, China, France, Japan, Spain, South Korea, UK, Germany, Poland, Brazil, Taiwan and Israel registers name Setidegrasib (also registered as ASP3082) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Setidegrasib trials recruiting patients?

Yes. 4 of the 5 trials are recruiting: 3 with sites in USA, 3 with sites in China, 3 with sites in France, 3 with sites in Japan, 2 with sites in Spain, 2 with sites in South Korea, 1 with sites in UK, 1 with sites in Germany, 1 with sites in Poland, 1 with sites in Brazil, 1 with sites in Taiwan and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Setidegrasib clinical trials?

Astellas Pharma Global Development, Inc (3), Astellas Pharma Inc (1) and Gustave Roussy, Cancer Campus, Grand Paris (1). The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Setidegrasib works or whether it is effective, and it is not medical advice.

Approvals, shortages and trials, every Friday

One email a week with new EMA and FDA approvals, EU and US medicine shortages, how many trials are recruiting in Ireland, and the week's Irish pharma news.

Free. Unsubscribe from any email with one click. See our privacy policy.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Setidegrasib works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Setidegrasib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.