Pipeline
Last Updated Date: April 29, 2021
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 Programs,1 18 through BD since Jan ‘19
NDA/BLA/MAA filings, P3 and Registrational P2 Trials
Clinical stage NMEs via in-licensing, and acquisitions accounting for 23 programs
Breakthrough Therapy Designations
1 Including in-licensed or acquired programs currently between Phase 1 and NDA/BLA/MAA approval. May include a small number of programs not referenced on this page.
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.
Viral Diseases
Emerging Virus
-
Remdesivir inhaled form (GS-5734)
Outpatient COVID-19
PHASE 1
HIV
-
Lenacapavir capsid inhibitor (GS-6207)1
Long acting HIV treatment for heavily treatment experienced people living with HIV
PHASE 2/3
-
Lenacapavir capsid inhibitor (GS-6207)
Long acting HIV treatment for virologically suppressed people living with HIV
PHASE 2
-
bNAb combination (GS-5423, GS-2872)2
HIV cure research program
PHASE 2
-
Lefitolimod TLR-9 agonist (GS-1703)2
HIV cure research program
PHASE 2
-
Vesatolimod TLR-7 agonist (GS-9620)
HIV cure research program
PHASE 2
-
Elipovimab bNAb (GS-9722)
HIV cure research program
PHASE 1
-
Unboosted protease inhibitor (GS-1156)
HIV treatment
PHASE 1
-
Long acting bictegravir (GS-9883)
Long acting HIV treatment
PHASE 1
HBV and HDV
-
Hepcludex® (bulevirtide)3
HDV
FILED MAA
-
Hepcludex® (bulevirtide) + PEG-INF
HDV
PHASE 2
-
Selgantolimod TLR-8 agonist (GS-9688)
HBV cure research program
PHASE 2
-
Oral PD-L1 small molecule (GS-4224)
HBV cure research program
PHASE 1
Potential Opt-in Programs
Gritstone
HIV cure
1 clinical stage program
1 Breakthrough therapy designation.
2 Non-Gilead sponsored trial(s) ongoing.
3 Conditionally approved by the European Medicines Agency (EMA) for the treatment of chronic HDV infection in adults with compensated liver disease in July 2020.
bNAb – Broadly neutralizing antibody.
Inflammatory Diseases
-
Filgotinib JAK-1 inhibitor (GS-6034)
Ulcerative colitis
FILED MAA
-
Filgotinib JAK-1 inhibitor (GS-6034)
Crohn's disease
PHASE 3
-
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)
Lupus
PHASE 1
-
Tirabrutintib BTK inhibitor (GS-4059)
Chronic spontaneous urticaria
PHASE 1
Fibrotic Diseases
-
Cilofexor FXR agonist (GS-9674)
Primary sclerosing cholangitis
PHASE 3
-
Cilofexor / firsocostat / semaglutide combination 1
Nonalcoholic steatohepatitis
PHASE 2
-
Selonsertib ASK1 inhibitor (GS-4997)
Diabetic kidney disease
PHASE 2
Potential Opt-in Programs
Galapagos2
Inflammatory and fibrotic diseases
8 clinical stage programs
1 Clinical collaboration with Novo Nordisk.
2 The collaborative agreement with Galapagos also includes opt in rights to multiple preclinical stage programs.
Oncology
Cell Therapy
-
Yescarta® (axi-cel)
2L Diffuse large B cell lymphoma
PHASE 3
-
Yescarta® (axi-cel)
1L Diffuse large B cell lymphoma
PHASE 2
-
Brexu-cel1,2
Adult acute lymphocytic leukemia
PHASE 2 sBLA
-
Brexu-cel1
Pediatric acute lymphocytic leukemia
PHASE 2 Pivotal
-
KITE-718 (MAGE-A3/A6)3
Solid tumors
PHASE 1
-
KITE-439 (HPV-16 E7)3
Solid tumors
PHASE 1
Non-Cell Therapy
-
Magrolimab anti-CD47 (GS-4721)4,5
Myelodysplastic syndrome
PHASE 3
-
Sacituzumab govitecan-hziy (GS-0132)
Hormone receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer
PHASE 3
-
Zimberelimab PD1 (GS-0122)6
Non-small cell lung cancer
PHASE 3
-
Sacituzumab govitecan-hziy (GS-0132)
Basket (incl. non-small cell lung cancer)
PHASE 2
-
Sacituzumab govitecan-hziy (GS-0132) + CPI6
Metastatic triple-negative breast cancer (1L), Metastatic urothelial cancer, Metastatic non-small cell lung cancer
PHASE 1b/2
-
Magrolimab anti-CD47 (GS-4721)
Acute myeloid leukemia
PHASE 1b/2
-
Magrolimab anti-CD47 (GS-4721)
Diffuse large B cell lymphoma
PHASE 1b/2
-
Sacituzumab govitecan-hziy (GS-0132) + PARPi6
Metastatic triple-negative breast cancer, Metastatic urothelial cancer, Ovarian
PHASE 1b/2
-
Oral PD-L1 small molecule inhibitor (GS-4224)
Non-small cell lung cancer
PHASE 1
-
Magrolimab anti-CD47 (GS-4721)
Solid tumors
PHASE 1b
-
Flt3R agonist (GS-3583)
Oncology
PHASE 1a
-
Anti-c-KIT (GS-0174)
Transplant conditioning regimen
PHASE 1a
-
Anti-SIRP-α (GS-0189)
Oncology
PHASE 1a
Potential Opt-in Programs
Arcus
Oncology
4 clinical stage programs
Agenus
Solid Tumors
2 clinical stage programs
Pionyr
Solid Tumors
2 clinical stage programs
Tizona
Advanced cancers
1 clinical stage program
1 Breakthrough therapy designation.
2 sBLA for accelerated approval filed.
3 Collaboration with NIH.
4 Breakthrough and PRIME designation for Promising Innovative Medicine from MHRA.
5Additional MDS and AML cohorts within other ongoing Ph 1b study.
6 Non-Gilead sponsored trial(s) ongoing.
Axi-cel - Axicabtagene ciloleucel.
Brexu-cel - Brexucabtagene autoleucel.
CPI – Checkpoint inhibitor.
PARPi – PARP inhibitor.
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