Pipeline

Last Updated Date: February 2, 2023

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.

59

Clinical Stage Programs1                                                        

13

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

  • Novel oral COVID-19 nucleoside (BIRCH)

    COVID-19

    PHASE 3

HIV

  • Lenacapavir (PURPOSE 1 & 2)

    HIV PrEP

    PHASE 3
  • Lenacapavir / bictegravir oral combination (ARTISTRY-1)

    HIV treatment for virologically suppressed treatment-experienced people living with HIV.

    PHASE 2
  • Lenacapavir1

    Long-acting HIV treatment for virologically suppressed people living with HIV

    PHASE 2
  • Lenacapavir/islatravir oral combination2

    Long-acting HIV treatment for virologically suppressed people living with HIV

    PHASE 2
  • bNAb combination (GS-5423, GS-2872)3

    HIV cure

    PHASE 2
  • Lefitolimod3

    HIV cure

    PHASE 2
  • Vesatolimod

    HIV cure

    PHASE 2
  • HIV bispecific T-cell engager (GS-8588)

    HIV cure

    PHASE 1
  • Lenacapavir / bNAb combination

    Long-acting HIV treatment for virologically suppressed people living with HIV

    PHASE 1
  • HIV long-acting injectable INSTI (GS-6212)

    Long-acting HIV treatment

    PHASE 1
  • HIV long-acting oral NNRTI (GS-5894)

    Long-acting HIV treatment

    PHASE 1
  • HIV long-acting oral INSTI (GS-1720)

    Long-acting HIV treatment

    PHASE 1

HBV and HDV

  • Hepcludex® (MYR301)4,5

    HDV

    FILED BLA
  • Bulevirtide (MYR301, MYR204)

    HDV Finite Treatment

    PHASE 3
  • Selgantolimod

    HBV cure

    PHASE 2

Potential Opt-in Programs

Gritstone

HIV Cure
1 clinical stage program

Aelix

HIV Cure
1 clinical stage program

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

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

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 Therapy and PRIME designations.

bNAb – Broadly neutralizing antibody
CoV – Coronavirus
HBV – Hepatitis B virus
HDV – Hepatitis delta virus
HIV – Human immunodeficiency virus
INSTI – Integrase strand transfer inhibitor
NNRTI – Non-nucleoside reverse transcriptase inhibitor
PrEP – Pre-exposure prophylaxis

Inflammatory Diseases

  • TPL2 inhibitor (GS-5290)

    Inflammatory bowel disease

    PHASE 1
  • IRAK4 inhibitor (GS-5718)

    Lupus

    PHASE 1
  • α4β7 inhibitor (GS-1427)

    Inflammatory bowel disease

    PHASE 1
  • BTLA agonist (GS-0272)

    Inflammatory diseases

    PHASE 1

Fibrotic Diseases

  • Cilofexor / firsocostat / semaglutide combination1

    Nonalcoholic steatohepatitis

    PHASE 2

Potential Opt-in Programs

Galapagos

Inflammatory and fibrotic diseases
3 clinical stage programs

1 Clinical collaboration with Novo Nordisk.

BTLA – B- and T-lymphocyte attenuator
IRAK4 – Interleukin 1 receptor associated kinase 4
TPL2 – Tumor progression locus 2

 

Oncology

Breast

  • Sacituzumab govitecan-hziy (ASCENT-03)

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

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

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

    PHASE 3
  • Sacituzumab govitecan-hziy + pembrolizumab (ASCENT-05)

    Adjuvant triple-negative breast cancer

    PHASE 3
  • Magrolimab + chemotherapy/SG combinations

    Triple-negative breast cancer

    PHASE 2

Lung

  • Sacituzumab govitecan-hziy (EVOKE-01)

    2-3L non-small cell lung cancer

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

    1L non-small cell lung cancer

    PHASE 3
  • Domvanalimab + zimberelimab + chemotherapy (STAR-121)3

    1L non-small cell lung cancer

    PHASE 3
  • Domvanalimab + zimberelimab (ARC-10)3

    1L non-small cell lung cancer

    PHASE 3
  • Domvanalimab + durvalumab (PACIFIC-8)4

    Stage 3 non-small cell lung cancer

    PHASE 3
  • Sacituzumab govitecan-hziy + pembrolizumab (EVOKE-02)1

    1L non-small cell lung cancer

    PHASE 2
  • Domvanalimab + zimberelimab + etrumadenant (ARC-7)3

    Non-small cell lung cancer

    PHASE 2

Genitourinary

  • Trodelvy® (TROPiCS-04)5

    2L metastatic urothelial carcinoma

    PHASE 3
  • Sacituzumab govitecan-hziy + combinations (TROPHY-U-01)

    1L metastatic urothelial carcinoma

    PHASE 2
  • Etrumadenant + zimberelimab combinations (ARC-6)3

    Metastatic castrate-resistant prostate cancer

    PHASE 1b/2

Gastrointestinal

  • Domvanalimab + zimberelimab + chemotherapy (STAR-221)3

    1L upper GI cancer

    PHASE 3
  • Etrumadenant + zimberelimab combinations (ARC-9)3

    Metastatic colorectal cancer

    PHASE 2
  • Quemliclustat + zimberelimab (ARC-8)3

    Metastatic pancreatic ductal adenocarcinoma

    PHASE 2
  • Magrolimab combinations

    Metastatic colorectal cancer

    PHASE 2

Other Solid Tumors

  • Sacituzumab govitecan-hziy (TROPiCS-03)

    Basket (Solid tumors)

    PHASE 2
  • Magrolimab + chemotherapy/IO combinations

    Head and neck squamous cell carcinoma

    PHASE 2
  • Magrolimab + chemotherapy

    Solid tumors

    PHASE 2

Hematological Malignancies

  • Magrolimab + azacitidine (ENHANCE)6,7

    1L higher risk myelodysplastic syndrome

    PHASE 3
  • Magrolimab + azacitidine (ENHANCE-2)7

    1L TP53m acute myeloid leukemia

    PHASE 3
  • Magrolimab + venetoclax + azacitidine (ENHANCE-3)

    1L unfit acute myeloid leukemia

    PHASE 3
  • Magrolimab combinations

    Multiple myeloma

    PHASE 2
  • Magrolimab combinations

    Diffuse large B-cell lymphoma

    PHASE 1b/2

Advanced Cancers

  • AB308 + zimberelimab (ARC-12)3,8

    Advanced cancers

    PHASE 1b
  • CCR8 (GS-1811)

    Advanced cancers

    PHASE 1a
  • MCL1 inhibitor (GS-9716)

    Advanced cancers

    PHASE 1a

Cell Therapy

  • Axicabtagene ciloleucel (ZUMA-22)

    2L+ high-risk follicular lymphoma

    PHASE 3
  • Axicabtagene ciloleucel (ZUMA-23)2

    1L high-risk large B-cell lymphoma

    PHASE 3
  • Axicabtagene ciloleucel (ZUMA-24)

    2L large B-cell lymphoma outpatient

    PHASE 2
  • Axicabtagene ciloleucel (ZUMA-12)

    1L large B-cell lymphoma

    PHASE 2
  • Brexucabtagene autoleucel (ZUMA-4)

    Pediatric acute lymphocytic leukemia

    PHASE 2 Pivotal
  • Brexucabtagene autoleucel (ZUMA-25)

    Basket (rare B-cell malignancies)

    PHASE 2
  • CAR-T ddBCMA9

    Relapsed/refractory multiple myeloma

    PHASE 2
  • CLL-1 (KITE-222)

    Relapsed/refractory acute myeloid leukemia

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

    3L+ large B-cell lymphoma

    PHASE 1

Potential Opt-in Programs

Pionyr

Advanced cancers
2 clinical stage programs

Agenus

Advanced cancers
1 clinical stage program

Arcus

Advanced cancers
1 clinical stage program

Tizona

Advanced cancers
1 clinical stage program

MacroGenics

Advanced cancers
1 clinical stage program

Galapagos

Advanced cancers
2 clinical stage program

1 In collaboration with Merck.

2 Publicly announced planned program (non-exhaustive).

3 In collaboration with Arcus Biosciences.

4 In collaboration with Arcus Biosciences and AstraZeneca.

5 The FDA granted accelerated approval for Trodelvy®️ in 2L mUC Apr 2021 based on TROPHY U-01 Phase 1b trial.

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

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

8 Phase 1/1b

9 Global strategic collaboration to co-develop and co-commercialize with Arcellx.

GI – Gastrointestinal
IO – Immuno-oncology
MCL1 – myeloid cell leukemia-1
PD-L1 – Programmed death-ligand 1
SG - Sacituzumab govitecan-hziy
TP53m – Tumor protein 53 mutation

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