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    Pipeline

    Last Updated Date: August 18, 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

    Pipeline

    Viral?Diseases

    Emerging Virus

    • Veklury (remdesivir) injectable form1

      COVID-19

      NDA/BLA/MAA NDA/MAA
    • 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 1
    • 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/TGF? 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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