Pipeline

Last Updated Date: August 2, 2022

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.

58

Clinical Stage Programs1                                                        

11

Potential clinical stage opt-in assets

1 Program count does not include potential partner opt-in programs or publicly announced planned programs.

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 Viruses

  • Oral CoV prodrug (GS-5245)

    COVID-19

    PHASE 1

HIV

  • Lenacapavir capsid inhibitor (CAPELLA)1

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

    FILED NDA/MAA
  • Lenacapavir capsid inhibitor (PURPOSE 1 & 2)

    HIV PrEP

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

    Long acting HIV treatment for virologically suppressed people living with HIV

    PHASE 2
  • Lenacapavir/islatravir oral combination2,4

    Long acting HIV treatment for virologically suppressed people living with HIV

    PHASE 2
  • bNAb combination (GS-5423, GS-2872)5

    HIV cure

    PHASE 2
  • Lefitolimod TLR-9 agonist (GS-1703)5

    HIV cure

    PHASE 2
  • Vesatolimod TLR-7 agonist (GS-9620)5

    HIV cure

    PHASE 2
  • Therapeutic vaccines6

    HIV cure

    PHASE 1
  • Lenacapavir / bNAb combination

    Long acting HIV treatment for virologically suppressed people living with HIV

    PHASE 1
  • Lenacapavir / bictegravir oral combination

    Long acting HIV treatment for virologically suppressed people living with HIV

    PHASE 1
  • Long acting bictegravir (GS-9883)

    Long acting HIV treatment

    PHASE 1
  • Long acting INSTI (GS-6212)

    Long acting HIV treatment

    PHASE 1
  • HIV NNRTI (GS-5894)

    Long acting HIV treatment

    PHASE 1

HBV and HDV

  • Hepcludex® (bulevirtide)7,8

    HDV

    FILED BLA
  • Hepcludex® (bulevirtide)

    HDV Finite Treatment

    PHASE 3
  • Selgantolimod TLR-8 agonist (GS-9688)

    HBV cure

    PHASE 2

1 Breakthrough therapy designation.

2 Program timeline pending resolution of clinical hold on studies evaluating islatravir.

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

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

5 Non-Gilead sponsored trial(s) ongoing.

Clinical collaboration with Gritstone.

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

8 Breakthrough and PRIME designations.

bNAb – Broadly neutralizing antibody.
TLR – Toll-like receptor.
INSTI – Integrase strand transfer inhibitor
NNRTI – Non-nucleoside reverse transcriptase inhibitor

Inflammatory Diseases

  • TPL2 inhibitor (GS-5290)

    Inflammatory bowel disease

    PHASE 1
  • IRAK4 inhibitor (GS-5718)

    Inflammatory bowel disease

    PHASE 1
  • IRAK4 inhibitor (GS-5718)

    Rheumatoid arthritis

    PHASE 1
  • IRAK4 inhibitor (GS-5718)1

    Lupus

    PHASE 1
  • α4β7 inhibitor (GS-1427)

    Inflammatory bowel disease

    PHASE 1

Fibrotic Diseases

  • Cilofexor FXR agonist (PRIMIS)

    Primary sclerosing cholangitis

    PHASE 3
  • Cilofexor / firsocostat / semaglutide combination2

    Nonalcoholic steatohepatitis

    PHASE 2

Potential Opt-in Programs

Galapagos

Inflammatory and fibrotic diseases
6 clinical stage programs3

1 Screening/enrollment paused pending evaluation of preliminary preclinical findings.

2 Clinical collaboration with Novo Nordisk.

3 Includes acquired CD19 CAR-T from CellPoint.

Oncology

  • Sacituzumab govitecan-hziy (TROPiCS-02)

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

    PHASE 3
  • Sacituzumab govitecan-hziy (EVOKE-01)

    2-3L non small cell lung cancer

    PHASE 3
  • Sacituzumab govitecan-hziy (ASCENT-03)1

    1L metastatic triple-negative breast cancer (PD-L1-)

    PHASE 3
  • Sacituzumab govitecan-hziy (ASCENT-04)1

    1L metastatic triple-negative breast cancer (PD-L1+)

    PHASE 3
  • Sacituzumab govitecan-hziy (EVOKE-03)1,2

    1L non small cell lung cancer

    PHASE 3
  • Magrolimab anti-CD47 (ENHANCE)3,4

    1L higher risk myelodysplastic syndrome

    PHASE 3
  • Magrolimab anti-CD47 (ENHANCE-2)4

    1L acute myeloid leukemia

    PHASE 3
  • Magrolimab anti-CD47 (ENHANCE-3)

    1L unfit acute myeloid leukemia

    PHASE 3
  • Domvanalimab + zimberelimab vs. zimberelimab vs. chemo (ARC-10)5

    1L non small cell lung cancer

    PHASE 3
  • Durvalumab ± domvanalimab
    (PACIFIC-8)6

    Stage 3 non small cell lung cancer

    PHASE 3
  • Domvanalimab + zimberelimab + chemo vs. pembrolizumab + chemo (STAR-121)2,5

    1L non small cell lung cancer

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

    1L non small cell lung cancer

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

    1L metastatic urothelial carcinoma

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

    Basket (Solid tumors)

    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)

    Multiple myeloma

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

    Triple-negative breast cancer

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

    Metastatic colorectal cancer

    PHASE 2
  • Zimberelimab vs. zimberelimab + domvanalimab vs. zimberelimab + domvanalimab + etrumadenant (ARC-7)5

    Non small cell lung cancer

    PHASE 2
  • Quemliclustat + zimberelimab + gemcitabine/nab-paclitaxel (ARC-8)5

    Metastatic pancreatic ductal adenocarcinoma

    PHASE 2
  • Etrumadenant combinations (ARC-9)5

    Metastatic colorectal cancer

    PHASE 2
  • Domvanalimab + zimberelimab ± chemo (ARC-21)2,5

    1-2L upper GI cancer

    PHASE 2
  • Etrumadenant combinations (ARC-6)5

    Metastatic castrate-resistant prostate cancer

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

    Diffuse large B-cell lymphoma

    PHASE 1b/2
  • AB308 + zimberelimab (ARC-12)5,7

    Advanced cancers

    PHASE 1b
  • Flt3R agonist (GS-3583)

    Advanced cancers

    PHASE 1b
  • Anti-c-KIT (GS-0174)

    Transplant conditioning regimen

    PHASE 1a
  • CCR8 (GS-1811)

    Advanced cancers

    PHASE 1a
  • MCL1 inhibitor (GS-9716)

    Advanced cancers

    PHASE 1a

Cell Therapy

  • Axi-cel (ZUMA-22)2

    2L+ high-risk follicular lymphoma

    PHASE 3
  • Axi-cel (ZUMA-23)2

    1L high-risk large B-cell lymphoma

    PHASE 3
  • Axi-cel2

    2L large B-cell lymphoma Outpatient

    PHASE 2
  • Axi-cel

    1L large B-cell lymphoma

    PHASE 2
  • Brexu-cel

    Pediatric acute lymphocytic leukemia

    PHASE 2 Pivotal
  • Brexu-cel2

    Basket (rare B-cell malignancies)

    PHASE 2
  • KITE-222 (CLL-1)

    Relapsed/refractory acute myeloid leukemia

    PHASE 1
  • KITE-363 (CD19/20 bicistronic)

    3L+ diffuse large B-cell lymphoma

    PHASE 1

Potential Opt-in Programs

Pionyr

Solid tumors
2 clinical stage programs

Agenus

Solid tumors
1 clinical stage program

Arcus

Advanced cancers
1 clinical stage program

Tizona

Advanced cancers
1 clinical stage program

1 In collaboration with Merck.

2 Publicly announced planned program (non-exhaustive).

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

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

5 In collaboration with Arcus Biosciences.

6 In collaboration with Arcus Biosciences and AstraZeneca.

7 Phase 1/1b

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

Some of the content on this page is not intended for users outside the United States.