Zydelig

(Idelalisib)

ApprovedSmall molecule

Idelalisib is used to treat certain types of blood cancers, specifically chronic lymphocytic leukemia and follicular lymphoma, by slowing or stopping the growth of cancer cells.[2] Zydelig is currently approved and in use across 7 indications[4].[1]

Zydelig is one of 161 small molecule programs targeting Non-Hodgkins Lymphoma. It is currently in Approved.

Indications

Total Trials

Active Trials

160

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Non-Hodgkins LymphomaUnknown

Lymphoma, Non-Hodgkin, FamilialUnknown

Chronic Lymphocytic LeukemiaRecruiting

Neoplasm of Mature B-CellsUnknown

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaActive, not recruiting

RelapseActive, not recruiting

Metastatic Colorectal CancerRecruiting

Non-Hodgkins LymphomaPreclinical

Unknown

Lymphoma, Non-Hodgkin, FamilialPreclinical

Unknown

Chronic Lymphocytic LeukemiaApproved

Recruiting

Neoplasm of Mature B-CellsPreclinical

Unknown

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaApproved

Active, not recruiting

RelapsePhase 1

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Recruiting

Competition

Competitive Landscape

159 competitors in Metastatic Colorectal Cancer

#DrugCompanyPhaseTrials

Camptosar

Pfizer

Phase 3

52 2

Keytruda

Merck & Co.

Phase 3

20 3

Opdivo

Bristol-Myers Squibb

Phase 3

13 4

Braftovi

Pfizer

Phase 3

12 5

Tecentriq

Roche

Phase 3

10 6

Zydelig

Gilead

Approved

1 7

FOLFIRI

Amgen

Phase 3

38 8

Yervoy

Bristol-Myers Squibb

Phase 3

7 9

Bayer Aspirin

Bayer

Phase 3

2 10

Lumakras

Amgen

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1Active, not recruiting

Relapse

NCT02787369

Phase 3Active, not recruiting

Chronic Lymphocytic Leukemia

NCT04666038

Q4 2027

Phase 3Active, not recruiting

Chronic Lymphocytic Leukemia

NCT02970318

Q4 2029

Phase 3Recruiting

CLL/SLL

NCT07139873

Q1 2030

Phase 3Recruiting

CLL

NCT06846671

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia18 trials

A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Completed· Gilead logo

Gilead·Phase 3·NCT01539512·220 enrolled

Mechanisms of Idelalisib-Associated Diarrhea in Patients With Relapsed Chronic Lymphocytic Leukemia, Indolent Non-hodgkin Lymphoma, or Small Lymphocytic Lymphoma

Terminated·JJonsson Comprehensive Cancer Center··NCT02928510·1 enrolled

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL)

Completed· Gilead logo

Gilead·Phase 1·NCT02242045·6 enrolled

Show 15 more trials

Ibrutinib or Idelalisib in Treating Patients With Persistent or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma After Donor Stem Cell Transplant

Withdrawn·FFred Hutchinson Cancer Center·Phase 2·NCT02662296

Study to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Completed· Gilead logo

Gilead·Phase 2·NCT02968563·35 enrolled

Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic Leukemia

Approved for marketing· Gilead logo

Gilead··NCT02136511

Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

Terminated· Gilead logo

Gilead·Phase 2·NCT02044822·102 enrolled

A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies

Withdrawn·JJuno Therapeutics, Inc., a Bristol-Myers Squibb Company·Phase 3·NCT06205290

Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04666038·238 enrolled

Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

Completed· Gilead logo

Gilead·Phase 1·NCT01088048·241 enrolled

Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)

Terminated· Gilead logo

Gilead·Phase 3·NCT01539291·161 enrolled

Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

Terminated· Gilead logo

Gilead·Phase 3·NCT01659021·261 enrolled

Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia

Terminated· Gilead logo

Gilead·Phase 3·NCT01980875·57 enrolled

Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia

Terminated· Gilead logo

Gilead·Phase 1·NCT02538614·2 enrolled

Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

Completed· Gilead logo

Gilead·Phase 3·NCT01569295·416 enrolled

Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia

Terminated· Gilead logo

Gilead·Phase 3·NCT01980888·311 enrolled

Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Recruiting· Eli Lilly logo

Eli Lilly·Approved·NCT07218341·150 enrolled

A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia

Active, not recruiting·AAcerta Pharma BV·Phase 3·NCT02970318·310 enrolled

Follicular Lymphoma6 trials

Dose Optimization Study of Idelalisib in Follicular Lymphoma

Terminated· Gilead logo

Gilead·Phase 3·NCT02536300·96 enrolled

Lenalidomide and Idelalisib in Treating Patients With Recurrent Follicular Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 1·NCT01644799·8 enrolled

Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma

Terminated·FFondazione Italiana Linfomi - ETS·Phase 2·NCT03890289·5 enrolled

Show 3 more trials

Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma

Completed· Gilead logo

Gilead··NCT03568929·257 enrolled

Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or Refractory Follicular Lymphoma

Terminated·AADC Therapeutics S.A.·Phase 2·NCT04699461·6 enrolled

Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma

Terminated· Gilead logo

Gilead·Phase 2·NCT02258529·10 enrolled

Lymphoma5 trials

Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas

Completed· Gilead logo

Gilead·Phase 2·NCT01282424·125 enrolled

Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma

Completed· Gilead logo

Gilead·Phase 2·NCT01393106·25 enrolled

Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma

Completed· Gilead logo

Gilead·Phase 1/2·NCT01306643·18 enrolled

Show 2 more trials

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Terminated· Gilead logo

Gilead·Phase 3·NCT01732913·295 enrolled

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Terminated· Gilead logo

Gilead·Phase 3·NCT01732926·475 enrolled

Acute Lymphoblastic Leukemia3 trials

REALIB-LLA-2017: Idelalisib in Patients With Acute Lymphoblastic Leukemia

Terminated·PPETHEMA Foundation·Phase 1/2·NCT03742323·6 enrolled

Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT01620216·12 enrolled

Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT02779283·7 enrolled

CLL/SLL2 trials

A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL

Completed·—·Phase 2·NCT02135133·27 enrolled

A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)

Recruiting·DDizal (Jiangsu) Pharmaceutical Co., Ltd.·Phase 3·NCT07139873·250 enrolled

22 more indications

Relapsed or Refractory Hematologic Malignancies1 trial

Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies

Terminated· Gilead logo

Gilead·Phase 2·NCT01796470·66 enrolled

Mantle Cell Lymphoma1 trial

Lenalidomide With or Without Idelalisib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 1·NCT01838434·106 enrolled

ART1 trial

Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

Terminated· Gilead logo

Gilead·Phase 4·NCT02739360·3 enrolled

Metastatic Colorectal Cancer1 trial

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·OOslo University Hospital·Phase 2·NCT05725200·40 enrolled

Essential Thrombocythemia1 trial

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease

Terminated· Gilead logo

Gilead·Phase 1·NCT02436135·10 enrolled

Relapse1 trial

ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL

Active, not recruiting·—·Phase 1·NCT02787369·3 enrolled

B-cell Malignancies1 trial

Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies

Terminated· Gilead logo

Gilead·Phase 1·NCT02457598·203 enrolled

LAL1 trial

An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study

Terminated· Gilead logo

Gilead·Phase 1/2·NCT01090414·202 enrolled

Hematopoietic Stem Cell Transplant (HSCT)1 trial

Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT03151057·16 enrolled

Lung Cancer1 trial

Pembrolizumab + Idelalisib for Lung Cancer Study

Terminated·AAsha Nayak·Phase 1/2·NCT03257722·4 enrolled

Macroglobulinemia1 trial

Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia

Completed·FFrench Innovative Leukemia Organisation·Phase 2·NCT02962401·50 enrolled

Chronic Lymphocytic Leukaemia1 trial

Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland

Completed· Gilead logo

Gilead··NCT03582098·112 enrolled

Elderly Patients1 trial

A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL

Terminated· Gilead logo

Gilead·Phase 2·NCT01203930·105 enrolled

Trial1 trial

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Amyloidosis1 trial

Idelalisib for Immunoglobulin M (IgM)-Associated Primary (AL) Amyloidosis

Terminated·JJohn Mark Sloan·Phase 2·NCT02590588·1 enrolled

Efficacy1 trial

Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi

Completed·MMorphoSys AG·Phase 2·NCT02639910·24 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma

Terminated· Gilead logo

Gilead·Phase 1·NCT02468557·16 enrolled

Carboplatin1 trial

Idelalisib With Rituximab, Ifosfamide, Carboplatin, Etoposide (RICE) in Children and Adolescents

Withdrawn· Gilead logo

Gilead·Phase 1·NCT03349346

Safety and Efficacy1 trial

Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCL

Completed· Novartis logo

Novartis·Phase 1·NCT02603445·20 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Trial of Idelalisib in Patients With Relapsed Diffuse Large B-cell Lymphoma

Completed·NNordic Lymphoma Group·Phase 2·NCT03576443·36 enrolled

CLL1 trial

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

Recruiting·BBeOne Medicines·Phase 3·NCT06846671·250 enrolled

Recurrent B-Cell Non-Hodgkin Lymphoma1 trial

A Phase II Study of Anti-PD-1 Antibody (MK-3475) in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Other Low Grade B Cell Non-Hodgkin Lymphoma (NHL)

Completed·MMayo Clinic·Phase 2·NCT02332980·65 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 23, 2014

ZYDELIG

NDA NDA205858

Sources

References

[1]
ClinicalTrials.gov — 56 trial records for Idelalisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zydelig drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Idelalisib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Idelalisib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA205858). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Zydelig. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: PI3-Kinase P110-Delta Subunit Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Gilead

Patent Landscape[6]

Patent Cliff

Mar 11, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9492449Mar 11, 2030

8865730Mar 5, 2033

10730879Mar 5, 2033

9469643Sep 2, 2033

Zydelig

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q4 2029

Q1 2030

Trials by Indication[1]

Chronic Lymphocytic Leukemia18 trials

Follicular Lymphoma6 trials

Lymphoma5 trials

Acute Lymphoblastic Leukemia3 trials

CLL/SLL2 trials

Relapsed or Refractory Hematologic Malignancies1 trial

Mantle Cell Lymphoma1 trial

ART1 trial

Metastatic Colorectal Cancer1 trial

Essential Thrombocythemia1 trial

Relapse1 trial

B-cell Malignancies1 trial

LAL1 trial

Hematopoietic Stem Cell Transplant (HSCT)1 trial

Lung Cancer1 trial

Macroglobulinemia1 trial

Chronic Lymphocytic Leukaemia1 trial

Elderly Patients1 trial

Trial1 trial

Amyloidosis1 trial

Efficacy1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Carboplatin1 trial

Safety and Efficacy1 trial

Diffuse Large B-Cell Lymphoma1 trial

CLL1 trial

Recurrent B-Cell Non-Hodgkin Lymphoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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