Idelalisib clinical trials
Idelalisib is named as an intervention in 6 current clinical trials in our UK, USA, Italy, Poland, Czechia, Canada, Australia, China, France, Spain, Belgium, Austria, Japan, Israel, Germany, South Korea, Ireland, Turkey, Taiwan, Singapore, Switzerland, Sweden, Netherlands, Brazil and Norway registers. 4 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Eli Lilly and Company (1). The most-studied condition is Chronic Lymphocytic Leukemia.
Where Idelalisib is approved
All regulators →Of the three regulators tracked here, the first to approve Idelalisib was the US, on 23 Jul 2014. It is approved in 3 of the 3 regulators tracked here.
- 6 EU orphan designations, most recently for treatment of splenic marginal-zone lymphoma (5 Aug 2013, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Idelalisib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Idelalisib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 2 Sep 2033 (US 9469643).
- Latest patent on the drug substance itself: 2 Sep 2033 (US 9469643).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
How Idelalisib works
All drug targets →- PI3-kinase p110-delta subunit inhibitor InhibitorTarget: PIK3CD phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit delta✓ In ChEMBL and the Guide to Pharmacology
- Follicular lymphomaPhase 3
- Hodgkins lymphomaPhase 2
- Waldenstrom macroglobulinemiaPhase 2
- Acute lymphoblastic leukemiaPhase 2
- Acute myeloid leukemiaPhase 2
- AmyloidosisPhase 2
- Colorectal cancerPhase 2
- Diffuse large B-cell lymphomaPhase 2
- Idiopathic pulmonary fibrosisPhase 2
- Indolent B-cell non-Hodgkin lymphomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2216870, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6741, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Idelalisib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Idelalisib. 3 are current, and 1 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Idelalisib for treating refractory follicular lymphoma NICE TA604 | Not recommended | 2 Oct 2019 | Current |
| Idelalisib with ofatumumab for treating chronic lymphocytic leukaemia (terminated appraisal) NICE TA469 | Terminated (no company submission) | 23 Aug 2017 | Current |
| Idelalisib for treating chronic lymphocytic leukaemia NICE TA359 | Recommended | 28 Oct 2015 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Idelalisib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ZydeligEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-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 Idelalisib
- ATC code
- L01XX47
- ChEMBL
- CHEMBL2216870
- DrugBank
- DB09054
- PubChem CID
- 11625818
- CAS number
- 870281-82-6
- FDA UNII
- YG57I8T5M0
- Wikidata
- Q5908266
- Wikipedia
- Idelalisib
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
Trials by phase
Clinical trials of Idelalisib
6 trialsRegisters 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.
Idelalisib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Idelalisib on the HPRA medicines list.
- Zydelig 100 mg film-coated tabletsGilead Sciences Ireland UC · EU/1/14/938/001
- Zydelig 150 mg film-coated tabletsGilead Sciences Ireland UC · EU/1/14/938/002
Supply shortages
- Idelalisib TabletUS (FDA) · Resolved · updated 7 Apr 2026
Conditions studied with Idelalisib
6 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Eli Lilly and Company | 1 |
| Loxo Oncology, Inc | 1 |
| Acerta Pharma BV | 1 |
| BeOne Medicines | 1 |
| Dizal Pharmaceuticals | 1 |
| Oslo University Hospital | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Idelalisib trials
How many clinical trials are testing Idelalisib?
6 current trials in our UK, USA, Italy, Poland, Czechia, Canada, Australia, China, France, Spain, Belgium, Austria, Japan, Israel, Germany, South Korea, Ireland, Turkey, Taiwan, Singapore, Switzerland, Sweden, Netherlands, Brazil and Norway registers name Idelalisib as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Idelalisib trials recruiting patients?
Yes. 4 of the 6 trials are recruiting: 2 with sites in UK, 2 with sites in USA, 2 with sites in Italy, 2 with sites in Poland, 2 with sites in Czechia, 2 with sites in Canada, 2 with sites in Australia, 2 with sites in China, 1 with sites in France, 1 with sites in Spain, 1 with sites in Belgium, 1 with sites in Austria, 2 with sites in Japan, 1 with sites in Israel, 1 with sites in Germany, 1 with sites in South Korea, 1 with sites in Ireland, 1 with sites in Turkey, 1 with sites in Netherlands, 1 with sites in Brazil and 1 with sites in Norway. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Idelalisib clinical trials?
Eli Lilly and Company (1), Loxo Oncology, Inc (1), Acerta Pharma BV (1) and BeOne Medicines (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Idelalisib clinical trials in Ireland?
Yes. 2 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Idelalisib licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Idelalisib, for example Zydelig 100 mg film-coated tablets (Gilead Sciences Ireland UC). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Idelalisib shortage?
The registers we track list 1 entry for Idelalisib: US FDA: resolved. Shortages are product- and country-specific; check with a pharmacist.
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 Idelalisib works or whether it is effective, and it is not medical advice.
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 Idelalisib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Idelalisib (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.