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Pipeline

Last Updated Date: August 4, 2023

We have the strongest and most diversified pipeline in our history and are on track to achieve our ambition, set in 2019, of delivering 10+ transformative therapies by 2030.

From long-acting HIV combinations to some of the most promising targets in cancer treatment, we’re discovering, evaluating and advancing investigational compounds that have the potential to transform care for life-threatening diseases. Through pioneering science and innovative partnerships, we’ll continue to expand our research and development programs to take on pressing unmet needs in virology, oncology and inflammation.

Learn more about our ambitions for each therapeutic area

64


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

Viral Diseases

Inflammatory

Oncology

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

  • Obeldesivir (BIRCH, OAKTREE)

    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
  • Lenacapavir + teropavimab + zinlirvimab4

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

    PHASE 2
  • Teropavimab + zinlirvimab3,4

    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
  • 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
  • HIV long-acting oral capsid inhibitor (GS-4182)

    Long-acting HIV treatment

    PHASE 1

HBV

  • Selgantolimod

    HBV cure

    PHASE 2
  • HBV therapeutic vaccine (GS-2829 + GS-6779)

    HBV cure

    PHASE 1

HDV

  • Hepcludex® (MYR301)5,6,7

    HDV

    FILED BLA
  • Bulevirtide (MYR301, MYR204)

    HDV cure

    PHASE 3

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 Teropavimab and zinlirvimab are bNABs.

5 Full Marketing Authorisation by the European Medicines Agency (EMA) for the treatment of adults with chronic HDV and compensated liver disease.

6 Breakthrough therapy and PRIME designations.

7 BLA resubmission to FDA pending.

BLA – Biologics License Application
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

  • Edecesertib (COSMIC)

    Lupus

    PHASE 2
  • Tilpisertib fosmecarbil

    Inflammatory bowel disease

    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
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
  • Sacituzumab govitecan-hziy (ASCENT-07)

    HR+/HER2- chemo-naïve metastatic breast cancer

    PHASE 3
  • Magrolimab + chemotherapy/SG combinations (ELEVATE TNBC)

    Metastatic triple-negative breast cancer

    PHASE 2

Lung and Thoracic

  • Sacituzumab govitecan-hziy (EVOKE-01)

    2-3L metastatic non-small cell lung cancer

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

    1L metastatic non-small cell lung cancer (PD-L1+, TPS>50%)

    PHASE 3
  • Domvanalimab + zimberelimab + chemotherapy (STAR-121)2

    1L metastatic non-small cell lung cancer

    PHASE 3
  • Domvanalimab + zimberelimab (ARC-10)2

    1L non-small cell lung cancer

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

    Stage 3 non-small cell lung cancer

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

    1L metastatic non-small cell lung cancer

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

    Metastatic non-small cell lung cancer

    PHASE 2
  • Lung cancer platform (VELOCITY-Lung4, EDGE-Lung2,5)

    Non-small cell lung cancer

    PHASE 2
  • Magrolimab + chemotherapy/IO combinations (ELEVATE HNSCC)

    Head and neck squamous cell carcinoma

    PHASE 2

Genitourinary

  • Trodelvy® (TROPiCS-04)6

    2L metastatic urothelial carcinoma

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

    1L metastatic urothelial carcinoma

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

    Metastatic castrate-resistant prostate cancer

    PHASE 1b/2

Gastrointestinal

  • Domvanalimab + zimberelimab + chemotherapy (STAR-221)2

    1L upper GI cancer

    PHASE 3
  • Etrumadenant + zimberelimab combinations (ARC-9)2

    Metastatic colorectal cancer

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

    Metastatic pancreatic ductal adenocarcinoma

    PHASE 2
  • Magrolimab combinations (ELEVATE CRC)

    Metastatic colorectal cancer

    PHASE 2

Other Solid Tumors

  • Sacituzumab govitecan-hziy (TROPiCS-03)

    Basket (Solid tumors)

    PHASE 2
  • Magrolimab + chemotherapy (ELEVATE Lung & UC)

    Solid tumors

    PHASE 2

Hematological Malignancies

  • Magrolimab + azacitidine (ENHANCE)7,8

    1L higher risk myelodysplastic syndrome

    PHASE 3
  • Magrolimab + azacitidine (ENHANCE-2)8

    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)2,9

    Advanced cancers

    PHASE 1b
  • CCR8 (GS-1811)

    Advanced cancers

    PHASE 1a
  • MCL1 inhibitor (GS-9716)

    Advanced cancers

    PHASE 1a
  • IL-2 Variant (GS-4528)

    Advanced cancers

    PHASE 1

Cell Therapy

  • Axicabtagene ciloleucel (ZUMA-22)

    2L+ high-risk follicular lymphoma

    PHASE 3
  • Axicabtagene ciloleucel (ZUMA-23)

    1L high-risk large B-cell lymphoma

    PHASE 3
  • Axicabtagene ciloleucel (ZUMA-24)

    2L large B-cell lymphoma outpatient

    PHASE 2
  • Brexucabtagene autoleucel (ZUMA-4)

    Pediatric acute lymphocytic leukemia/ non-Hodgkin lymphoma

    PHASE 2
  • Brexucabtagene autoleucel (ZUMA-25)

    Basket (rare B-cell malignancies)

    PHASE 2
  • CAR-T ddBCMA (Kite-772) (iMMagine-1)10,11

    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

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 In collaboration with Arcus Biosciences.

3 In collaboration with Arcus Biosciences and AstraZeneca.

4 VELOCITY-Lung includes combinations of domvanalimab, etrumadenant, zimberelimab, and sacituzumab govitecan-hziy.

5 EDGE-Lung includes immunotherapy-based combinations of quemliclustat, domvanalimab, and zimberelimab.

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

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

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

9 Phase 1/1b

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

11 Program timeline pending resolution of clinical hold on CAR-T ddBCMA for the treatment of patients with R/R MM.

 

HR+/HER2-mBC – Hormone receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer
GI – Gastrointestinal
IO – Immuno-oncology
MCL1 – Myeloid cell leukemia-1
PD-L1 – Programmed death-ligand 1
SG – Sacituzumab govitecan-hziy
TPS – Tumor proportion scale
TP53m – Tumor protein 53 mutation

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