Pipeline

Last Updated Date: Oct. 28, 2021

The impossible is simply what hasn’t been achieved yet. Gilead’s research and development program is focused on what’s next. We discover, identify and evaluate investigational compounds that show potential to advance the treatment of life-threatening diseases.

45


Clinical Stage Programs1                                                   

17


NDA/BLA/MAA filings, Phase 3 and Registrational Phase 2 Trials

1 Including in-licensed or acquired programs currently between Phase 2 and NDA/BLA/MAA approval.

On this page

Pack of testing vials laid out inside a Gilead laboratory

The safety and efficacy of the following investigational compounds or investigational uses of marketed products have not been established. These uses have not been approved by the U.S. Food and Drug Administration or other regulatory authorities unless otherwise noted.

Viral Diseases

HIV

  • Lenacapavir capsid inhibitor (GS-6207)1

    Long acting HIV treatment for heavily treatment experienced people living with HIV

    FILED NDA/MAA
  • Lenacapavir capsid inhibitor (GS-6207)

    HIV PrEP

    PHASE 3
  • Lenacapavir capsid inhibitor (GS-6207)2

    Long acting HIV treatment for virologically suppressed people living with HIV

    PHASE 2
  • Lenacapavir/islatravir oral combination3

    Long acting HIV treatment for virologically suppressed people living with HIV

    PHASE 2
  • bNAb combination (GS-5423, GS-2872)4

    HIV cure

    PHASE 2
  • Lefitolimod TLR-9 agonist (GS-1703)4

    HIV cure

    PHASE 2
  • Vesatolimod TLR-7 agonist (GS-9620)4

    HIV cure

    PHASE 2

HBV and HDV

  • Hepcludex® (bulevirtide)5,6

    HDV

    FILED MAA
  • Hepcludex® (bulevirtide)

    HDV

    PHASE 2
  • Selgantolimod TLR-8 agonist (GS-9688)

    HBV cure

    PHASE 2

1 Breakthrough therapy designation. 

2 Phase 2 study being conducted in treatment naïve patients to support virologically suppressed indication.

3 Subject to Gilead and Merck co-development and co-commercialization agreement.

4 Non-Gilead sponsored trial(s) ongoing.

5 Conditionally approved by the European Medicines Agency (EMA) for the treatment of chronic HDV infection in adults with compensated liver disease in July 2020.

6 Breakthrough and PRIME designations.

bNAb – Broadly neutralizing antibody.

TLR – Toll-like receptor.

Inflammatory Diseases

  • Filgotinib JAK-1 inhibitor (GS-6034)

    Ulcerative colitis

    FILED MAA
  • Filgotinib JAK-1 inhibitor (GS-6034)

    Crohn's disease

    PHASE 3

Fibrotic Diseases

  • Cilofexor FXR agonist (GS-9674)

    Primary sclerosing cholangitis

    PHASE 3
  • Cilofexor / firsocostat / semaglutide combination1

    Nonalcoholic steatohepatitis

    PHASE 2
  • Selonsertib ASK1 inhibitor (GS-4997)

    Diabetic kidney disease

    PHASE 2

Potential Opt-in Programs

Galapagos

Inflammatory and fibrotic diseases
7 clinical stage programs2

1 Clinical collaboration with Novo Nordisk.

2 Includes six Phase 1 programs.

Oncology

  • Magrolimab anti-CD47 (GS-4721)1,2

    1L higher risk myelodysplastic syndrome

    PHASE 3
  • Magrolimab anti-CD47 (GS-4721)2

    1L acute myeloid leukemia

    PHASE 3
  • Sacituzumab govitecan-hziy (GS-0132)

    Hormone receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer 

    PHASE 3
  • Zimberelimab anti-PD-1 (GS-0122)3

    1L non-small cell lung cancer

    PHASE 3
  • Sacituzumab govitecan-hziy (GS-0132)

    Basket (incl. non-small cell lung cancer)

    PHASE 2
  • Magrolimab anti-CD47 (GS-4721)

    Head and neck squamous cell carcinoma

    PHASE 2
  • Magrolimab anti-CD47 (GS-4721)

    Solid tumors

    PHASE 2
  • Magrolimab anti-CD47 (GS-4721)

    Diffuse large B-cell lymphoma

    PHASE 1b/2

Cell Therapy

  • Yescarta® (axi-cel)

    2L large B-cell lymphoma

    FILED sBLA
  • Yescarta® (axi-cel)

    1L large B-cell lymphoma

    PHASE 2
  • Brexu-cel4

    Pediatric acute lymphocytic leukemia

    PHASE 2 Pivotal

Potential Opt-in Programs

Arcus

Solid tumors
4 clinical stage programs5

Pionyr

Solid tumors
2 clinical stage programs6

Agenus

Solid tumors
1 clinical stage program5

Tizona

Advanced cancers
1 clinical stage program5

1 Breakthrough and PRIME designations and Promising Innovative Medicine from MHRA.

2Additional MDS and AML cohorts within other ongoing Phase 1b study.

3 Non-Gilead sponsored trial(s) ongoing. 

4 Breakthrough therapy designation.

5 Includes one Phase 1 program.

6 Includes two Phase 1 programs.

Axi-cel – Axicabtagene ciloleucel.
Brexu-cel – Brexucabtagene autoleucel.

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