Drugs / Idelalisib
Idelalisib
also known as
CAL-101 · GS-1101 · IDELA · CAL-101 (GS-1101) · GS-11CAL-101 · IDELALISIBCT-CAL101IDEALISIBCAL-101CAL 101GS-1101GS 1101ZYDELIGA-1138CAL101 · Zydelig
Small molecule targets PIK3CD via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Zydelig | — | 2014-09-18 | europa.eu ↗ |
| Approved | US (FDA) | ZYDELIG | — | 2014-07-23 | fda.gov ↗ |
Trials 53 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00836914 Comparator | Feb → Mar 2009 | allergic rhinitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04699461 Comparator | Nov 2021 → Nov 2022 | follicular lymphoma | ADC Therapeutics S.A. | Terminated | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07139873 Comparator | Sep 2025 → Jan 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06846671 Comparator | Apr 2025 → May 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT06205290 Comparator | Jan 2024 → Oct 2031 | B-cell chronic lymphocytic leukemia | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Withdrawn | No outcome recorded |
| Phase 3 | NCT04666038 Comparator | Mar 2021 → Aug 2023 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Loxo Oncology, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02970318 Comparator | Feb 2017 → Sep 2021 overdue | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01539512 Comparator | Apr 2012 → Oct 2013 | B-cell chronic lymphocytic leukemia | Gilead Sciences | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02136511 Background | — | B-cell chronic lymphocytic leukemia | Gilead Sciences | Approved for marketing | No outcome recorded |
Press releases naming this drug 15 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-12-08 | Gilead Sciences | Phase 3 Results for Zydelig® With Bendamustine and Rituximab for Relapsed Chronic Lymphocytic Leukemia (CLL) Presented at American Society of Hematology Annual Meeting gilead.com ↗ |
| 2015-11-16 | Gilead Sciences | Gilead’s Zydelig® Combined with Bendamustine and Rituximab Shows Superior Efficacy to Bendamustine/Rituximab in Phase 3 Study of Patients with Relapsed Chronic Lymphocytic Leukemia gilead.com ↗ |
| 2015-05-31 | Gilead Sciences | Zydelig® in Combination With Ofatumumab Improves Progression-Free Survival in Previously-Treated Patients With Chronic Lymphocytic Leukemia gilead.com ↗ |
| 2014-12-08 | Gilead Sciences | Gilead Presents Follow-up Data from Zydelig Registrational Studies in Patients with Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma gilead.com ↗ |
| 2014-09-19 | Gilead Sciences | European Commission Grants Marketing Authorization for Gilead’s Zydelig® (Idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma gilead.com ↗ |
| 2014-07-25 | Gilead Sciences | European CHMP Adopts Positive Opinion for Gilead’s Zydelig® (idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma gilead.com ↗ |
| 2014-07-23 | Gilead Sciences | U.S. Food and Drug Administration Approves Gilead’s Zydelig® (idelalisib) for Relapsed Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma gilead.com ↗ |
| 2014-01-13 | Gilead Sciences | U.S. FDA Accepts New Drug Application for Gilead’s Idelalisib for the Treatment of Refractory Indolent Non-Hodgkin’s Lymphoma gilead.com ↗ |
| 2013-12-08 | Gilead Sciences | Gilead Announces Pivotal Phase 2 Data for Idelalisib in Refractory Indolent Non-Hodgkin’s Lymphoma gilead.com ↗ |
| 2013-11-18 | Gilead Sciences | Gilead’s Idelalisib Significantly Reduces Rate of Disease Progression or Death in Phase 3 Chronic Lymphocytic Leukemia Study gilead.com ↗ |
| 2013-10-09 | Gilead Sciences | Gilead to Stop Phase 3 Study 116 of Idelalisib in Chronic Lymphocytic Leukemia Early Because of Positive Risk-Benefit gilead.com ↗ |
| 2013-09-11 | Gilead Sciences | Gilead Submits New Drug Application to U.S. FDA for Idelalisib for the Treatment of Indolent Non-Hodgkin’s Lymphoma gilead.com ↗ |
| 2013-06-17 | Gilead Sciences | Gilead Announces Interim Phase 2 Data for Idelalisib Showing Response in Refractory Indolent Non-Hodgkin’s Lymphoma gilead.com ↗ |
| 2013-05-15 | Gilead Sciences | Gilead Announces Response Data from Phase 2 Study of Idelalisib for Previously Untreated Chronic Lymphocytic Leukemia gilead.com ↗ |
| 2012-05-01 | Gilead Sciences | Gilead Initiates Phase 3 Clinical Trial Evaluating GS-1101 for the Treatment of Chronic Lymphocytic Leukemia gilead.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 66 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Idelalisib | “This research study is evaluating a drug called idelalisib (formerly known as GS-1101 or CAL-101) as a possible treatment for Waldenstrom's Macroglobulinemia (WM).” NCT02439138 ↗55“100 mg QD of idelalisib + 100 mg QD of venetoclax” NCT03639324 ↗ |
| Known as | CAL-101 | “A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL” NCT02135133 ↗5“phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor GS-1101 (CAL-101)” NCT01659047 ↗ |
| Known as | CAL-101 (GS-1101) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2216870 ↗ |
| Known as | GS-1101 | “This research study is evaluating a drug called idelalisib (formerly known as GS-1101 or CAL-101) as a possible treatment for Waldenstrom's Macroglobulinemia (WM).” NCT02439138 ↗2“Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor, Idelalisib (GS-1101), in IgM-Associated AL Amyloid” NCT02590588 ↗ |
| Known as | GS-11CAL-101 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2216870 ↗ |
| Known as | IDELA | “A randomized, double-blind, phase III study of idelalisib (IDELA) plus rituximab versus placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) was...” PMID 30995176 ↗ Apr 20191“Cohort 1a: Idelalisib (IDELA) 100 mg orally twice daily (BID)” NCT01088048 ↗ |
| Known as | IDELALISIBCT-CAL101IDEALISIBCAL-101CAL 101GS-1101GS 1101ZYDELIGA-1138CAL101 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2216870 ↗ |
| Known as | Zydelig | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03133221 ↗ |
| Action | Inhibit | “an oral inhibitor of phosphatidylinositol 3-kinase (PI3K) delta” NCT00836914 ↗ |
| Modality | Small molecule | “Idelalisib is a small-molecule inhibitor of PI3Kδ” PMID 27247136 ↗ May 2016 |
| Route | Oral | “administered orally” NCT00836914 ↗ |
| Target | PIK3CD | “The phosphatidylinositol-3-kinase delta (PI3Kδ) inhibitor idelalisib” PMID 28327905 ↗ May 2017 |