Pipeline

Last Updated Date: July 29, 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.

51


Clinical Stage Programs1                                      

16


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

1 Including in-licensed or acquired programs currently between Phase 1 and NDA/BLA/MAA approval. Note that only select (and not all) Phase 1 programs are referenced on this page.

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
  • 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
  • bNAb combination (GS-5423, GS-2872)3

    HIV cure

    PHASE 2
  • Lefitolimod TLR-9 agonist (GS-1703)3

    HIV cure

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

    HIV cure

    PHASE 2

HBV and HDV

  • Hepcludex® (bulevirtide)4,5

    HDV

    FILED MAA
  • Hepcludex® (bulevirtide) +/- PEG-IFNα

    HDV

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

    HBV cure

    PHASE 2

Potential Opt-in Programs

Gritstone

HIV cure
1 clinical stage program

1 Breakthrough therapy designation.

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

3 Non-Gilead sponsored trial(s) ongoing.

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

5 Breakthrough and PRIME designations.

bNAb – Broadly neutralizing antibody.

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 combination

    Nonalcoholic steatohepatitis

    PHASE 2
  • Selonsertib ASK1 inhibitor (GS-4997)

    Diabetic kidney disease

    PHASE 2

Potential Opt-in Programs

Galapagos1

Inflammatory and fibrotic diseases
7 clinical stage programs

1 The collaborative agreement with Galapagos also includes opt-in rights to multiple preclinical stage programs.



Oncology

  • Magrolimab anti-CD47 (GS-4721)1,2

    Myelodysplastic syndrome

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

    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 PD1 (GS-0122)3

    Non-small cell lung cancer

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

    Basket (incl. non-small cell lung cancer)

    PHASE 2
  • Sacituzumab govitecan-hziy (GS-0132) + CPI3

    Metastatic triple-negative breast cancer (1L), Metastatic urothelial cancer, Metastatic non-small cell lung cancer

    PHASE 1b/2
  • Magrolimab anti-CD47 (GS-4721)

    Diffuse large B-cell lymphoma

    PHASE 1b/2

Cell Therapy

  • Yescarta® (axi-cel)

    2L large B-cell lymphoma

    PHASE 3
  • Yescarta® (axi-cel)

    1L large B-cell lymphoma

    PHASE 2
  • Brexu-cel4

    Adult acute lymphocytic leukemia

    PHASE 2 sBLA / Type II
  • Brexu-cel4

    Pediatric acute lymphocytic leukemia

    PHASE 2 Pivotal
  • KITE-718 (MAGE-A3/A6)5

    Solid tumors

    PHASE 1
  • KITE-439 (HPV-16 E7)5

    Solid tumors

    PHASE 1

Potential Opt-in Programs

Arcus

Oncology
4 clinical stage programs

Agenus

Solid tumors
2 clinical stage programs

Pionyr

Solid tumors
2 clinical stage programs

Tizona

Advanced cancers
1 clinical stage program

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 Collaboration with NIH.

Axi-cel – Axicabtagene ciloleucel.
Brexu-cel – Brexucabtagene autoleucel.
CPI – Checkpoint inhibitor.

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