Pipeline
Updated: Aug. 8, 2024, data as of end of Q2
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.
Total programs
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.
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Virology
Emerging Viruses
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Obeldesivir (OAKTREE)
COVID-19
Phase 3
HIV
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Lenacapavir (PURPOSE 1 & 2)
HIV pre-exposure prophylaxis (PrEP)
Phase 3
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Lenacapavir/bictegravir oral combination (ARTISTRY-1 & ARTISTRY-2)
HIV treatment for virologically suppressed treatment-experienced and virologically suppressed people living with HIV
Phase 3
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Lenacapavir/islatravir oral combination
Long-acting HIV treatment for virologically suppressed people living with HIV
Phase 2
Notes
Subject to Gilead and Merck co-development and co-commercialization agreement.
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Lenacapavir + teropavimab + zinlirvimab
Long-acting HIV treatment for virologically suppressed people living with HIV
Phase 2
Notes
Teropavimab and zinlirvimab are broadly neutralizing antibodies (bNAbs).
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Teropavimab + zinlirvimab
HIV cure
Phase 2
Notes
Non-Gilead sponsored trial(s) ongoing.
Teropavimab and zinlirvimab are broadly neutralizing antibodies (bNAbs).
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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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HIV long-acting injectable INSTI (GS-6212)
Long-acting HIV treatment
Phase 1
Notes
INSTI – Integrase strand transfer inhibitor
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HIV long-acting oral INSTI (GS-1720)
Long-acting HIV treatment
Phase 1
Notes
INSTI – Integrase strand transfer inhibitor
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HIV long-acting oral capsid inhibitor (GS-4182)
Long-acting HIV treatment
Phase 1
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HIV long-acting injectable NRTTI (GS-1614)
Long-acting HIV treatment
Phase 1
Notes
Subject to Gilead and Merck co-development and co-commercialization agreement.
NRTTI - nucleoside reverse transcriptase translocation inhibitor
HBV
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Selgantolimod
HBV cure
Phase 2
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HBV therapeutic vaccine (GS-2829 + GS-6779)
HBV cure
Phase 1
HDV
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Hepcludex® (MYR301)
HDV
Phase 3
Notes
Full Marketing Authorisation by the European Medicines Agency (EMA) for the treatment of adults with chronic HDV and compensated liver disease.
Breakthrough Therapy and PRIME designations.
Biologics License Application resubmission to FDA pending.
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Bulevirtide (MYR204)
HDV Finite
Phase 2
Potential Opt-in Programs
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Assembly Biosciences
HBV, HSV
2 CLINICAL STAGE PROGRAMS
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Gritstone
HIV Cure
1 CLINICAL STAGE PROGRAMS
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Hookipa
HIV Cure
1 CLINICAL STAGE PROGRAMS
Oncology
Breast
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Sacituzumab govitecan-hziy (ASCENT-03)
1L metastatic triple-negative breast cancer (PD-L1-)
Phase 3
Notes
PD-L1 – programmed death-ligand 1
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Sacituzumab govitecan-hziy + pembrolizumab (ASCENT-04)
1L metastatic triple-negative breast cancer (PD-L1+)
Phase 3
Notes
In collaboration with Merck.
PD-L1 – programmed death-ligand 1
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Sacituzumab govitecan-hziy + pembrolizumab (ASCENT-05)
Adjuvant triple-negative breast cancer
Phase 3
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Sacituzumab govitecan-hziy (ASCENT-07)
HR+/HER2- chemo-naïve metastatic breast cancer
Phase 3
Notes
HR+/HER2- - Hormone receptor positive, human epidermal growth factor receptor 2 negative
Lung and Thoracic
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Sacituzumab govitecan-hziy + pembrolizumab (EVOKE-03)
1L metastatic non-small cell lung cancer (PD-L1+, TPS>50%)
Phase 3
Notes
In collaboration with Merck.
PD-L1 – Programmed death-ligand 1
TPS – tumor proportion scale
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Domvanalimab + zimberelimab + chemotherapy (STAR-121)
1L metastatic non-small cell lung cancer
Phase 3
Notes
In collaboration with Arcus Biosciences.
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Sacituzumab govitecan-hziy + pembrolizumab (EVOKE-02)
1L metastatic non-small cell lung cancer
Phase 2
Notes
In collaboration with Merck.
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Domvanalimab + zimberelimab + etrumadenant (ARC-7)
Metastatic non-small cell lung cancer
Phase 2
Notes
In collaboration with Arcus Biosciences.
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Lung cancer platform (VELOCITY-Lung, EDGE-Lung)
Non-small cell lung cancer
Phase 2
Notes
VELOCITY-Lung includes combinations of domvanalimab, etrumadenant, zimberelimab, and sacituzumab govitecan-hziy.
EDGE-Lung, in collaboration with Arcus Biosciences, includes immunotherapy-based combinations of quemliclustat, domvanalimab, and zimberelimab
Genitourinary
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Trodelvy® (TROPiCS-04)
2L metastatic urothelial carcinoma
Phase 3
Notes
The FDA granted accelerated approval for Trodelvy®️ in 2L mUC Apr 2021 based on TROPHY U-01 Phase 1b trial.
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Sacituzumab govitecan-hziy + combinations (TROPHY U-01)
1L metastatic urothelial carcinoma
Phase 2
Gastrointestinal
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Domvanalimab + zimberelimab + chemotherapy (STAR-221)
1L upper gastrointestinal cancer
Phase 3
Notes
In collaboration with Arcus Biosciences.
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Etrumadenant + zimberelimab combinations (ARC-9)
Metastatic colorectal cancer
Phase 2
Notes
In collaboration with Arcus Biosciences.
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Quemliclustat +/- zimberelimab (ARC-8)
Metastatic pancreatic ductal adenocarcinoma
Phase 2
Notes
In collaboration with Arcus Biosciences.
Other Solid Tumors
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Sacituzumab govitecan-hziy (TROPiCS-03)
Basket (Solid tumors)
Phase 2
Advanced Cancers
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CCR8 (GS-1811)
Advanced cancers
Phase 1
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MCL1 inhibitor (GS-9716)
Advanced cancers
Phase 1
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IL-2 Variant (GS-4528)
Advanced cancers
Phase 1
Notes
IL – Interleukin
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PARP1 inhibitor (GS-0201)
Advanced Cancers
Phase 1
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DGKα inhibitor (GS-9911)
Advanced cancers
Phase 1
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Masked IL-12 (XTX301)
Advanced Cancers
Phase 1
Notes
Operationalized by Xilio.
Cell Therapy
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Axicabtagene ciloleucel (ZUMA-22)
2L+ high-risk follicular lymphoma
Phase 3
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Axicabtagene ciloleucel (ZUMA-23)
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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Brexucabtagene autoleucel (ZUMA-4)
Pediatric acute lymphocytic leukemia/ non-Hodgkin lymphoma
Phase 2
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Anitocabtagene autoleucel (iMMagine-1)
Relapsed/refractory multiple myeloma
Phase 2
Notes
Global strategic collaboration to co-develop and co-commercialize with Arcellx.
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CD19/CD20 bicistronic (KITE-363)
Relapsed/refractory diffuse large B-cell lymphoma
Phase 1
Notes
CD 19 and 20 are B-lymphocyte antigens. CD – cluster of differentiation
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CD19/CD20 bicistronic (KITE-753)
Relapsed/refractory diffuse large B-cell lymphoma
Phase 1
Notes
Manufacturing innovation.
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CD19 CAR (KITE-197)
Relapsed/refractory diffuse large B-cell lymphoma
Phase 1
Notes
Manufacturing innovation.
Potential Opt-in Programs
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Agenus
Advanced cancers
1 CLINICAL STAGE PROGRAMS
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Arcus
Advanced cancers
3 CLINICAL STAGE PROGRAMS
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MacroGenics
Advanced cancers
1 CLINICAL STAGE PROGRAMS
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Galapagos
Advanced cancers
3 CLINICAL STAGE PROGRAMS
Inflammation
Inflammatory Diseases
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Seladelpar (RESPONSE)
Primary Biliary Cholangitis
FILED NDA/MAA
Notes
PRIME Designation and Breakthrough Therapy Designation
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Edecesertib (COSMIC)
Lupus
Phase 2
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Tilpisertib fosmecarbil (PALEKONA)
Inflammatory bowel disease
Phase 2
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α4β7 inhibitor (SWIFT)
Inflammatory bowel disease
Phase 2
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BTLA agonist (GS-0272)
Inflammatory diseases
Phase 1
Notes
BTLA - B- and T-lymphocyte attenuator
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PD1 agonist (GS-0151)
Inflammatory Diseases
Phase 1
Fibrotic Diseases
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Cilofexor / firsocostat / semaglutide combination (WAYFIND)
Nonalcoholic steatohepatitis
Phase 2
Notes
Clinical collaboration with Novo Nordisk.
Potential Opt-in Programs
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Galapagos
Inflammatory diseases
1 CLINICAL STAGE PROGRAMS