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Pipeline

Last Updated Date: October 22, 2020

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.

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.

42

Clinical Stage Programs1

12

NDA/BLA/MAA, P3 and Registrational P2 Trials

17

NMEs via In-Licensing, Options, and Product Acquisitions

3

Breakthrough Therapy Designations2

1 Including in-licensed or acquired.

2 Expected submission and/or approvals in 2021.

On this page

Viral Diseases

Inflammatory Diseases

Oncology

Pack of testing vials laid out inside a Gilead laboratory

Viral Diseases

Emerging Virus

  • Remdesivir inhaled form

    COVID-19

    Phase 1

HIV

  • Lenacapavir capsid inhibitor (GS-6207)

    HIV LA HTE

    Phase 3 Registrational for HTE
  • Lenacapavir capsid inhibitor (GS-6207)

    HIV LA virologically suppressed2

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

    HIV cure3 

    Phase 2
  • LefitolimodTLR-9 agonist

    HIV cure3

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

    HIV cure

    Phase 1
  • Elipovimab bNAb (GS-9722)

    HIV cure

    Phase 1
  • Unboosted protease inhibitor (GS-1156)

    HIV treatment

    Phase 1

HBV

  • Selgantolimod TLR-8 agonist (GS-9688)

    HBV cure

    Phase 2
  • PD-L1 inhibitor (GS-4224)

    HBV cure

    Phase 1

1 European Commission Conditional Marketing Approval and US Emergency Use Authorization granted.

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

3 Phase 2 studies are academic collaborations.

HTE – heavily treatment-experienced.

Inflammatory Diseases

  • Filgotinib JAK-1 inhibitor (GS-6034)

    Rheumatoid arthritis

    NDA/BLA/MAA NDA/MAA
  • Filgotinib JAK-1 inhibitor (GS-6034)

    Ulcerative colitis

    Phase 3
  • Filgotinib JAK-1 inhibitor (GS-6034)

    Crohn's disease

    Phase 3
  • Filgotinib JAK-1 inhibitor (GS-6034)

    Psoriatic arthritis

    Phase 3
  • Filgotinib JAK-1 inhibitor (GS-6034)

    Ankylosing spondylitis

    Phase 2
  • Filgotinib JAK-1 inhibitor (GS-6034)

    Uveitis

    Phase 2
  • TPL2 inhibitor (GS-4875)

    Ulcerative colitis

    Phase 2
  • ADAMTS-5 Inhibitor (GLPG-1972)1

    Osteoarthritis

    Phase 2
  • IRAK4 inhibitor (GS-5718)

    IBD

    Phase 1
  • GLPG-33121

    Inflammatory diseases

    Phase 1
  • GLPG-39701

    Inflammatory diseases

    Phase 1
  • GLPG-36671

    Inflammatory diseases

    Phase 1
  • GLPG-31211

    Inflammatory diseases

    Phase 1
  • GLPG-05551

    Osteoarthritis

    Phase 1

Fibrotic Diseases

  • Cilofexor FXR agonist (GS-9674)

    PSC

    Phase 3
  • Ziritaxestat ATX inhibitor (GLPG-1690)2

    Idiopathic pulmonary fibrosis

    Phase 3
  • Cilofexor, firsocostat combination3

    NASH

    Phase 2
  • Selonsertib ASK1 inhibitor (GS-4997)

    DKD

    Phase 2
  • Ziritaxestat ATX inhibitor (GLPG-1690)2

    Systemic sclerosis

    Phase 2
  • GLPG-12051

    Idiopathic pulmonary fibrosis

    Phase 2

1 Optionable partner program.

2 Optioned partner program.

3 Combination of cilofexor FXR agonist and firsocostat ACC inhibitor (selonsertib no longer included).

Oncology

Cell Therapy

  • Axi-cel

    2L DLBCL

    Phase 3
  • Axi-cel

    Indolent NHL

    Phase 2 Pivotal
  • Axi-cel

    1L DLBCL

    Phase 2
  • Axi-cel

    3L DLBCL (+rituximab)

    Phase 2
  • Brexu-cel

    Adult ALL

    Phase 2 Pivotal
  • Brexu-cel

    Pediatric ALL

    Phase 2 Pivotal
  • Axi-cel

    3L DLBCL (+mavrilimumab)

    Phase 2
  • Axi-cel

    3L DLBCL (+lenzilumab)

    Phase 2
  • Brexu-cel

    CLL

    Phase 1
  • Axi-cel

    3L DLBCL (+utomilumab)

    Phase 1
  • KITE-718 (MAGE-A3/A6)

    Solid tumor

    Phase 1
  • KITE-439 (HPV-16 E7)

    Solid tumor

    Phase 1

Non-Cell Therapy

  • Arcus – TIGIT1

    ONC

    Phase 2
  • Arcus – Adenosine Antagonist1

    ONC

    Phase 2
  • Arcus – PD12

    ONC

    Phase 1
  • Magrolimab (GS-4721)

    MDS

    Phase 3
  • Magrolimab (GS-4721)

    AML

    Phase 1
  • Magrolimab (GS-4721)

    NHL

    Phase 1
  • Arcus – CD73 SM1

    ONC

    Phase 1
  • Oral PD-L1 SM (GS-4224)

    NSCLC

    Phase 1
  • Anti-CD73/TGFß TRAP (GS-1423)1

    Solid tumor

    Phase 1
  • Bi-specific mAb (AGEN1223)1

    Multiple

    Phase 1
  • Anti-CD137 mAb (AGEN2373)1

    Multiple

    Phase 1

1 Optionable Partner Program.

2 In-licensed from Arcus.

3 Q1’20 representation of program phase based on criteria used by Forty Seven.

Axi-cel- Axicabtagene Ciloleucel.
Brexu-cel - brexucabtageneautoleucel, formerly KTE-X19.
ALL - Acute lymphocytic leukemia.
CLL - Chronic lymphocytic leukemia.
DLBCL - Diffuse large B-cell lymphoma.
iNHL - Indolent non-Hodgkin lymphoma.
MCL - Mantle cell lymphoma.

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