Pipeline
Last Updated Date: February 3, 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.
Clinical Stage Programs1
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 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 unless otherwise noted.
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Novel oral COVID-19 nucleoside (BIRCH)
COVID-19
PHASE 3
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Lenacapavir (PURPOSE 1 & 2)
HIV PrEP
PHASE 3
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Lenacapavir / bictegravir oral combination (ARTISTRY-1)
HIV treatment for virologically suppressed treatment-experienced people living with HIV.
PHASE 2
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Lenacapavir1
Long-acting HIV treatment for virologically suppressed people living with HIV
PHASE 2
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Lenacapavir/islatravir oral combination2
Long-acting HIV treatment for virologically suppressed people living with HIV
PHASE 2
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bNAb combination (GS-5423, GS-2872)3
HIV cure
PHASE 2
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Lefitolimod3
HIV cure
PHASE 2
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Vesatolimod
HIV cure
PHASE 2
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HIV bispecific T-cell engager (GS-8588)
HIV cure
PHASE 1
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Lenacapavir / bNAb combination
Long-acting HIV treatment for virologically suppressed people living with HIV
PHASE 1
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HIV long-acting injectable INSTI (GS-6212)
Long-acting HIV treatment
PHASE 1
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HIV long-acting oral NNRTI (GS-5894)
Long-acting HIV treatment
PHASE 1
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HIV long-acting oral INSTI (GS-1720)
Long-acting HIV treatment
PHASE 1
HBV and HDV
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Hepcludex® (MYR301)4,5
HDV
FILED BLA
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Bulevirtide (MYR301, MYR204)
HDV Finite Treatment
PHASE 3
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Selgantolimod
HBV cure
PHASE 2
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
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TPL2 inhibitor (GS-5290)
Inflammatory bowel disease
PHASE 1
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IRAK4 inhibitor (GS-5718)
Lupus
PHASE 1
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α4β7 inhibitor (GS-1427)
Inflammatory bowel disease
PHASE 1
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BTLA agonist (GS-0272)
Inflammatory diseases
PHASE 1
Fibrotic Diseases
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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
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Sacituzumab govitecan-hziy (ASCENT-03)
1L metastatic triple-negative breast cancer (PD-L1-)
PHASE 3
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Sacituzumab govitecan-hziy + pembrolizumab (ASCENT-04)1
1L metastatic triple-negative breast cancer (PD-L1+)
PHASE 3
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Sacituzumab govitecan-hziy + pembrolizumab (ASCENT-05)
Adjuvant triple-negative breast cancer
PHASE 3
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Magrolimab + chemotherapy/SG combinations
Triple-negative breast cancer
PHASE 2
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Sacituzumab govitecan-hziy (EVOKE-01)
2-3L non-small cell lung cancer
PHASE 3
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Sacituzumab govitecan-hziy + pembrolizumab (EVOKE-03)1,2
1L non-small cell lung cancer
PHASE 3
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Domvanalimab + zimberelimab + chemotherapy (STAR-121)3
1L non-small cell lung cancer
PHASE 3
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Domvanalimab + zimberelimab (ARC-10)3
1L non-small cell lung cancer
PHASE 3
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Domvanalimab + durvalumab (PACIFIC-8)4
Stage 3 non-small cell lung cancer
PHASE 3
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Sacituzumab govitecan-hziy + pembrolizumab (EVOKE-02)1
1L non-small cell lung cancer
PHASE 2
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Domvanalimab + zimberelimab + etrumadenant (ARC-7)3
Non-small cell lung cancer
PHASE 2
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Trodelvy® (TROPiCS-04)5
2L metastatic urothelial carcinoma
PHASE 3
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Sacituzumab govitecan-hziy + combinations (TROPHY-U-01)
1L metastatic urothelial carcinoma
PHASE 2
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Etrumadenant + zimberelimab combinations (ARC-6)3
Metastatic castrate-resistant prostate cancer
PHASE 1b/2
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Domvanalimab + zimberelimab + chemotherapy (STAR-221)3
1L upper GI cancer
PHASE 3
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Etrumadenant + zimberelimab combinations (ARC-9)3
Metastatic colorectal cancer
PHASE 2
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Quemliclustat + zimberelimab (ARC-8)3
Metastatic pancreatic ductal adenocarcinoma
PHASE 2
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Magrolimab combinations
Metastatic colorectal cancer
PHASE 2
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Sacituzumab govitecan-hziy (TROPiCS-03)
Basket (Solid tumors)
PHASE 2
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Magrolimab + chemotherapy/IO combinations
Head and neck squamous cell carcinoma
PHASE 2
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Magrolimab + chemotherapy
Solid tumors
PHASE 2
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Magrolimab + azacitidine (ENHANCE)6,7
1L higher risk myelodysplastic syndrome
PHASE 3
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Magrolimab + azacitidine (ENHANCE-2)7
1L TP53m acute myeloid leukemia
PHASE 3
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Magrolimab + venetoclax + azacitidine (ENHANCE-3)
1L unfit acute myeloid leukemia
PHASE 3
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Magrolimab combinations
Multiple myeloma
PHASE 2
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Magrolimab combinations
Diffuse large B-cell lymphoma
PHASE 1b/2
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AB308 + zimberelimab (ARC-12)3,8
Advanced cancers
PHASE 1b
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CCR8 (GS-1811)
Advanced cancers
PHASE 1a
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MCL1 inhibitor (GS-9716)
Advanced cancers
PHASE 1a
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Axicabtagene ciloleucel (ZUMA-22)
2L+ high-risk follicular lymphoma
PHASE 3
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Axicabtagene ciloleucel (ZUMA-23)2
1L high-risk large B-cell lymphoma
PHASE 3
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Axicabtagene ciloleucel (ZUMA-24)
2L large B-cell lymphoma outpatient
PHASE 2
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Axicabtagene ciloleucel (ZUMA-12)
1L large B-cell lymphoma
PHASE 2
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Brexucabtagene autoleucel (ZUMA-4)
Pediatric acute lymphocytic leukemia
PHASE 2 Pivotal
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Brexucabtagene autoleucel (ZUMA-25)
Basket (rare B-cell malignancies)
PHASE 2
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CAR-T ddBCMA9
Relapsed/refractory multiple myeloma
PHASE 2
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CLL-1 (KITE-222)
Relapsed/refractory acute myeloid leukemia
PHASE 1
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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
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