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 · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed B-cell chronic lymphocytic leukemia 2 milestones | |||||
| Filed | US (FDA) | Zydelig | B-cell chronic lymphocytic leukemia | 2015-05-31 | “Based on the Study 119 trial results, Gilead has filed a supplemental New Drug Application (sNDA) with the U.S.” gilead.com ↗ |
| Filed | US (FDA) | — | B-cell chronic lymphocytic leukemia | 2013-12-06 | “Gilead submitted an NDA for idelalisib for the treatment of CLL on December 6, 2013 .” gilead.com ↗ |
| Filed indolent B-cell non-Hodgkin lymphoma 1 milestone | |||||
| Filed | EU (EMA) | — | indolent B-cell non-Hodgkin lymphoma | 2013-11-20 | “Gilead’s Marketing Authorization Application (MAA) for idelalisib for the treatment of iNHL and CLL was validated by the European Medicines Agency (EMA) on November 20.” gilead.com ↗ “In addition, Gilead submitted Marketing Authorisation Applications for both iNHL and CLL in Europe .” gilead.com ↗ |
| Filed indolent primary cutaneous B-cell lymphoma 1 milestone | |||||
| Filed | US (FDA) | — | indolent primary cutaneous B-cell lymphoma | 2013-09-11 | “On September 11, 2013, Gilead submitted a New Drug Application to the U.S. Food and Drug Administration for idelalisib for the treatment of refractory iNHL.” gilead.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Zydelig | — | 2014-09-18 | europa.eu ↗ |
| Approved | US (FDA) | ZYDELIG | — | 2014-07-23 | fda.gov ↗ |
Trials 53
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2022-06-04 | AstraZeneca | Results Calquence plus obinutuzumab demonstrated sustained survival benefit in 1st-line chronic lymphocytic leukaemia with 90% of patients surviving five years in ELEVATE-TN trial astrazeneca.com ↗
At 42 months, an estimated 62% of patients treated with Calquence were alive and had not progressed in comparison with 19% of patients treated with IdR/BR. |
| 2018-11-01 | Gilead Sciences | Results Gilead to Present Latest Scientific Research in Hematologic Malignancies and Solid Tumors at ASH 2018 gilead.com ↗
Results From a Prospective Real World Study Show Strong Efficacy of Idelalisib in CLL, Including High-Risk CLL |
| 2015-12-08 | Gilead Sciences | Results 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 ↗
Gilead Sciences , Inc. (Nasdaq: GILD) today announced results from a prespecified interim analysis of a Phase 3 study (Study 115) evaluating Zydelig ® (idelalisib) in combination with bendamustine and rituximab (BR) for patients with previously treated CLL. |
| 2015-11-16 | Gilead Sciences | Results 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 | Results Zydelig® in Combination With Ofatumumab Improves Progression-Free Survival in Previously-Treated Patients With Chronic Lymphocytic Leukemia gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from the Phase 3 clinical Study 119 of an investigational use of Zydelig ® (idelalisib) in combination with ofatumumab in previously-treated patients with chronic lymphocytic leukemia (CLL). |
| 2014-12-08 | Gilead Sciences | Results Gilead Presents Follow-up Data from Zydelig Registrational Studies in Patients with Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma gilead.com ↗
Gilead Sciences , Inc. (NASDAQ: GILD) today announced long-term follow-up results from the registration studies further describing the duration of response, progression-free survival (PFS) and safety profile for Zydelig ® (idelalisib) in relapsed patients with chronic lymphocytic leukemia (CLL) and two types of indolent non-Hodgkin lymphoma (iNHL). |
| 2014-09-19 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Zydelig® (Idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for Zydelig ® (idelalisib), 150 mg tablets, a first-in-class oral treatment for two incurable blood cancers - chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). |
| 2014-07-25 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Zydelig® (idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Zydelig ® (idelalisib 150 mg film-coated tablets), a first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), the most common subtype of indolent non-Hodgkin lymphoma (iNHL). |
| 2014-07-23 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Zydelig® (idelalisib) for Relapsed Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Zydelig ® (idelalisib) 150 mg tablets for the treatment of three B-cell blood cancers. |
| 2014-01-13 | Gilead Sciences | Regulatory 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 | Results Gilead Announces Pivotal Phase 2 Data for Idelalisib in Refractory Indolent Non-Hodgkin’s Lymphoma gilead.com ↗
In this study, single-agent treatment with idelalisib achieved an overall response rate of 57 percent with a median duration of response of 12.5 months. |
| 2013-11-18 | Gilead Sciences | Results Gilead’s Idelalisib Significantly Reduces Rate of Disease Progression or Death in Phase 3 Chronic Lymphocytic Leukemia Study gilead.com ↗
Study 116 Stopped for Positive Efficacy in October; Met Primary Endpoint of Progression-Free Survival and Secondary Endpoints of Overall Response, Lymph Node Response and Overall Survival |
| 2013-10-09 | Gilead Sciences | Results Gilead to Stop Phase 3 Study 116 of Idelalisib in Chronic Lymphocytic Leukemia Early Because of Positive Risk-Benefit gilead.com ↗
This DMC recommendation is based on a predefined interim analysis showing highly statistically significant efficacy for the primary endpoint of progression-free survival in patients receiving idelalisib plus rituximab compared to those receiving rituximab alone. |
| 2013-09-11 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. FDA for Idelalisib for the Treatment of Indolent Non-Hodgkin’s Lymphoma gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for approval of idelalisib, an investigational, targeted, oral inhibitor of PI3K delta, for the treatment of indolent non-Hodgkin’s lymphoma (iNHL). |
| 2013-06-17 | Gilead Sciences | Results Gilead Announces Interim Phase 2 Data for Idelalisib Showing Response in Refractory Indolent Non-Hodgkin’s Lymphoma gilead.com ↗
In the study, single-agent treatment with idelalisib achieved an overall response rate of 53.6 percent, with a median duration of response at this interim analysis of 11.9 months. |
| 2013-05-15 | Gilead Sciences | Results Gilead Announces Response Data from Phase 2 Study of Idelalisib for Previously Untreated Chronic Lymphocytic Leukemia gilead.com ↗
This regimen achieved a complete response (CR) rate of 19 percent and an overall response rate (ORR) of 97 percent, with estimated progression-free survival (PFS) at 24 months of 93 percent. |
All press releases naming this drug 17 releases
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 |