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Pipeline

Last Updated Date: February 18, 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, 2 18 through BD since Jan ‘19

16

NDA/BLA/MAA filings, P3 and Registrational P2 Trials

13

Clinical stage NMEs via in-licensing, and acquisitions accounting for 23 programs

7

Breakthrough Therapy Designations

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

2 Includes Hepcludex. Agreement to acquire MYR has been announced but not yet closed.

 

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

Emerging Virus

  • Veklury® (remdesivir for injection)

    Outpatient COVID-19

    PHASE 3
  • Remdesivir inhaled form (GS-5734)

    Outpatient COVID-19

    PHASE 1

HIV

  • Lenacapavir capsid inhibitor (GS-6207)1

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

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

    Long acting HIV treatment for virologically suppressed people living with HIV

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

    HIV cure research program

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

    HIV cure research program

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

    HIV cure research program

    PHASE 2
  • Elipovimab bNAb (GS-9722)

    HIV cure research program

    PHASE 1
  • Effector IgG #2 (GS-9723)

    HIV cure research program

    PHASE 1
  • Unboosted protease inhibitor (GS-1156)

    HIV treatment

    PHASE 1
  • Long acting bictegravir (GS-9883)

    Long acting HIV treatment

    PHASE 1

HBV and HDV

  • Hepcludex® (bulevirtide)3,4

    HDV

    FILED MAA
  • Hepcludex® (bulevirtide)3 + PEG-INF

    HDV

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

    HBV cure research program

    PHASE 2
  • Oral PD-L1 small molecule (GS-4224)

    HBV cure research program

    PHASE 1

1 Breakthrough therapy designation.

2 Non-Gilead sponsored trial(s) ongoing.

3 From agreement to acquire MYR. Transaction has been announced but not yet closed. Closing of transaction subject to regulatory clearances and other conditions.

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.

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
  • TPL2 inhibitor (GS-5290)

    Inflammatory bowel disease

    PHASE 1
  • IRAK4 inhibitor (GS-5718)

    Inflammatory bowel disease

    PHASE 1
  • IRAK4 inhibitor (GS-5718)

    Lupus

    PHASE 1
  • Tirabrutintib BTK inhibitor (GS-4059)

    Chronic spontaneous urticaria

    PHASE 1

Fibrotic Diseases

  • Cilofexor FXR agonist (GS-9674)

    Primary sclerosing cholangitis

    PHASE 3
  • Cilofexor / firsocostat combination

    Nonalcoholic steatohepatitis

    PHASE 2
  • Selonsertib ASK1 inhibitor (GS-4997)

    Diabetic kidney disease

    PHASE 2

Potential Opt-in Programs

Galapagos1

Inflammatory and fibrotic diseases
8 clinical stage programs

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

Oncology

Cell Therapy

  • Tecartus® (Brexu-cel)1

    Mantle cell lymphoma

    FILED MAA/BLA
  • Axi-cel2

    Indolent non-Hodgkin's lymphoma

    FILED sBLA
  • Yescarta® (Axi-cel)

    2L Diffuse large B cell lymphoma

    PHASE 3
  • Yescarta® (Axi-cel)

    1L Diffuse large B cell lymphoma

    PHASE 2
  • Yescarta® (Axi-cel)3

    3L Diffuse large B cell lymphoma (+rituximab)

    PHASE 2
  • Brexu-cel2

    Adult acute lymphocytic leukemia

    PHASE 2 Pivotal
  • Brexu-cel2

    Pediatric acute lymphocytic leukemia

    PHASE 2 Pivotal
  • Yescarta® (Axi-cel)4

    3L Diffuse large B cell lymphoma (+lenzilumab)

    PHASE 1
  • Brexu-cel

    Chronic lymphocytic leukemia

    PHASE 1
  • Yescarta® (Axi-cel)5

    3L Diffuse large B cell lymphoma (+utomilumab)

    PHASE 1
  • KITE-718 (MAGE-A3/A6)6

    Solid tumors

    PHASE 1
  • KITE-439 (HPV-16 E7)6

    Solid tumors

    PHASE 1

Non-Cell Therapy

  • Trodelvy® Sacituzumab govitecan-hziy2,7

    Metastatic triple-negative breast cancer (3L)

    FILED sBLA
  • Sacituzumab govitecan-hziy (GS-0132)2,8

    Urothelial (3L+)

    FILED sBLA
  • Magrolimab anti-CD47 (GS-4721)9

    Myelodysplastic syndrome

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

    Hormone receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer (3L+)

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

    Basket (incl. non-small cell lung cancer)

    PHASE 2
  • Zimberelimab PD1 (GS-0122)10

    Non-small cell lung cancer

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

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

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

    Acute myeloid leukemia

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

    Diffuse large B cell lymphoma

    PHASE 1b/2
  • Sacituzumab govitecan-hziy (GS-0132) + PARPi

    Metastatic triple-negative breast cancer, Metastatic urothelial cancer, Ovarian

    PHASE 1b/2
  • Anti-CD73/TGFβ Trap (GS-1423)

    Oncology

    PHASE 1
  • Oral PD-L1 small molecule inhibitor (GS-4224)

    Non-small cell lung cancer

    PHASE 1
  • Magrolimab anti-CD47 (GS-4721)

    Solid tumors

    PHASE 1
  • Flt3R agonist (GS-3583)

    Oncology

    PHASE 1
  • Anti-c-KIT (GS-0174)

    Transplant conditioning regimen

    PHASE 1a
  • Anti-SIRP-a (GS-0189)

    Oncology

    PHASE 1a

Potential Opt-in Programs

Arcus

Oncology
3 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 Conditional approvals.

2 Breakthrough therapy designation.

3 Clinical collaboration with Genentech.

4 Clinical collaboration with Humanigen.

5 Clinical collaboration with Pfizer.

6 Collaboration with NIH.

7 sBLA for full approval filed, accelerated approval granted.

8 sBLA for accelerated approval filed.

9 Breakthrough and PRIME designation.

10 Non-Gilead sponsored trial(s) ongoing.

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

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