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Gilead Sciences, Inc.

Drugmaker with rare disease work · based in Foster City, United States · founded 1987 · ticker GILD · gilead.com

Gilead Sciences, Inc. works on 19 rare diseases we track, including Acute Myeloid Leukemia, Chronic Graft-versus-Host Disease and 17 more. It has 14 active clinical trials, and 7 are looking for volunteers now. It also has 3 FDA-approved rare disease drugs.

Gilead Sciences is a drug company based in Foster City, California, founded in 1987, that works mainly on HIV, viral hepatitis, cancer and inflammation. Its rare disease medicines include Livdelzi (seladelpar) for primary biliary cholangitis and, through its cell therapy company Kite, CAR T-cell therapies such as Yescarta. Kite is developing anito-cel for multiple myeloma, which the FDA is due to decide on by December 23, 2026.

Gilead Sciences, Inc. pipeline

Each row lists the diseases Gilead Sciences, Inc. is studying at that stage, from the ones closest to approval down to the earliest work.

Approved
Drugs the FDA has approved.
Phase 3
Large studies, usually the last step before a company asks the FDA for approval.
Phase 2
Mid-size studies that check whether a drug works and at what dose.

Non-hodgkin Lymphoma recruiting · Mesothelioma recruiting · Large B-cell Lymphoma recruiting · Multiple Myeloma

Phase 1
First studies in people, mostly checking safety.
Other studies
Studies with no phase listed, such as registries and natural history studies.

Non-hodgkin Lymphoma,B Cell recruiting

Gilead Sciences, Inc. clinical trials

These are Gilead Sciences, Inc. trials for the rare diseases we track, from ClinicalTrials.gov. Statuses there can lag behind company news, so confirm with the study team before you plan around one.

7 trials looking for volunteers now

Looking for volunteersPhase 1Recently updatedNCT07304154

Study of KITE-363 in Participants With Autoimmune Neurologic Diseases That Did Not Respond to Usual Treatment

Tests KITE-363, Fludarabine, Cyclophosphamide

For Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis and Multiple Sclerosis

This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed/refractory autoimmune neurologic diseases. The primary objectives of this study are: * To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases * To determine the recommended dose for Phase 1b * To evaluate the safety and preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases

Ages 18 Years - 75 Years10 locations
View full study
Looking for volunteersPhase 3Recently updatedNCT06051617

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Tests Seladelpar, Placebo

For Primary Biliary Cholangitis

The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis. The primary objective of this study is to evaluate the effect of seladelpar compared to placebo on EFS. EFS is defined as the time from start of treatment to the first occurrence of any of the following adjudicated events up to Week 156.

Ages 18 Years+217 locations
View full study
Looking for volunteersPhase 2Recently updatedNCT07763210

Intrathecal Cytarabine and Hydrocortisone for the Early Treatment of ICANS in Patients Undergoing CAR T Therapy for Non Hodgkin Lymphoma

Tests Therapeutic Hydrocortisone, Cytarabine, Dexamethasone, Methylprednisolone, Cyclophosphamide, Axicabtagene Ciloleucel, Brexucabtagene Autoleucel

For Non-hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma and Refractory Marginal Zone Lymphoma

The goal of this clinical trial is to reduce the duration of ICANS and incidence of G3 or great ICANS in participants who receive axi-cel. The main questions the study aims to answer are: Efficacy of IT therapy to reduce high-grade ICANS in participants who receive axi-cel in NHL compared to historical experience. This phase II trial tests how well giving intrathecal (IT) cytarabine and hydrocortisone works for the early treatment of immune effector cell associated neurotoxicity syndrome (ICANS) in patients undergoing chimeric antigen response (CAR) t cell therapy for the treatment of non Hodgkin Lymphoma that has come back after a period of improvement (recurrent) or that has not responded o previous treatment (refractory). CAR T-cell therapy can sometimes cause an overactive immune response and inflammation. This can cause a side effect called ICANS that affects the rain and may lead to symptoms such as confusion, difficulty speaking, or other neurological problems. Giving cytarabine and hydrocortisone directly into the fluid around the brain and spinal cord (called intrathecal treatment) may help lower the body's immune response and reduce inflammation. Giving IT cytarabine and hydrocortisone may be effective for early treatment of CANS in patients undergoing CAR T cell therapy for relapsed or refractory non Hodgkin Lymphoma.

Ages 18 Years+1 location
View full study
Looking for volunteersPhase 1Recently updatedNCT07451054

CD45BE-HSPC + CART-45 Cells

Tests CART-45 cells, CD45BE-HSPC

For B-Cell Non-Hodgkin Lymphoma (NHL), Richter's Transformation, T-Cell Non-Hodgkin Lymphoma and Hodgkin Lymphoma

This is a phase 1, open-label, dose-finding study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous base edited anti-CD45 CAR T cells (referred to as "CART-45 cells") following an autologous transplant of CD45 base edited hematopoietic stem and progenitor cells (referred to as "CD45BE-HSPC") in patients with relapsed or refractory hematologic malignancies.

Ages 18 Years+1 location
View full study
Looking for volunteersPhase 2Updated a few months agoNCT06477419

A Study of Sacituzumab Govitecan in People With Mesothelioma

Tests Sacituzumab govitecan-hziy

For Mesothelioma, Mesotheliomas Pleural and Mesothelioma; Pleura

Participants will receive sacituzumab govitecan until their disease gets worse (progresses), they have severe side effects and cannot continue study treatment, or the participants or the study doctor thinks it's in your best interest to stop treatment.

Ages 18 Years+7 locations
View full study
Looking for volunteersPhase 2No updates in a whileNCT06104592

Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL

Tests Comprehensive Ablative Bridging Irradiation (CABI), Chimeric Antigen Receptor T-Cell Therapy

For Large B-cell Lymphoma and Relapsed Non-Hodgkin Lymphoma

This is a phase 2, single-arm, open-label study to evaluate the safety and efficacy of comprehensive bridging radiation therapy prior to CD19 CAR T-cell therapy for large B-cell lymphoma patients with bulky disease, defined as any lesion ≥5 cm.

Ages 18 Years+1 location
View full study
Looking for volunteersNo updates in a whileNCT06156774

SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project

Tests Chimeric Antigen Receptor T-cells (CAR-T) therapy

For Non-hodgkin Lymphoma,B Cell

This is a multicenter prospective observational study lead by the FIL on sarcopenia and sGA as possible predictors of efficacy and toxicity outcomes in patients undergoing CAR-T cells treatment.

Ages 18 Years+21 locations
View full study

7 trials underway, not taking new volunteers

Underway, not taking new volunteersPhase 1Recently updatedNCT05457010

Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome.

Tests SPRX002, ARC-T Cells, Cyclophosphamide, Fludarabine

For Acute Myeloid Leukemia and Myelodysplastic Syndromes

Master Protocol: The main goal of this master clinical trial study is to assesses the safety, tolerability, pharmacokinetic (PK), Pharmacodynamic (PD) in participants with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The goal of the Arm 1 study is to assess the safety, tolerability, PK, and PD of the study drugs, Antigen Receptor Complex T (ARC-T) cells and CD123-specific soluble protein antigen-receptor X-linker (SPRX002), in participants with relapsed or refractory AML or MDS. The primary objective of this study is to assess the safety profile (including any dose-limiting toxicity (DLT)), to determine recommended Phase 2 dose (RP2D) of the investigational agents when infused in participants with relapsed and refractory AML or MDS.

Ages 18 Years+5 locations
View full study
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FDA-approved drugs from Gilead Sciences, Inc.

From the openFDA database. Tap a drug for side effects, dosing and help paying.

Cayston aztreonam

For Cystic Fibrosis. Approved Feb 22, 2010.

Letairis ambrisentan

For Pulmonary Arterial Hypertension. Approved Jun 15, 2007. Taken by mouth.

Livdelzi seladelpar lysine

For Primary Biliary Cholangitis. Approved Aug 14, 2024. Taken by mouth.

More about Gilead Sciences, Inc.

Within its broader pharmaceutical portfolio, Gilead Sciences, Inc. has active clinical trial programs and drug development efforts across 19 rare diseases, including Acute Myeloid Leukemia, Chronic Graft-versus-Host Disease, Chronic Inflammatory Demyelinating Polyneuropathy, Cystic Fibrosis, Hodgkin Lymphoma, and 14 additional rare conditions. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows active and recruiting rare disease studies sponsored by Gilead Sciences, Inc., sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites.

The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Gilead Sciences, Inc. is headquartered in Foster City, United States, founded in 1987, publicly traded under the ticker symbol GILD. The company maintains a dedicated rare disease division alongside its broader therapeutic portfolio, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Where Gilead Sciences, Inc. trials take place

The trials above run at 514 study sites in 33 countries. Tap a country to see its states, cities and hospitals.

United States
185▼
Italy
39▼
Spain
28▼
United Kingdom
24▼
France
21▼
China
20▼
Germany
18▼
South Korea
17▼
Canada
16▼
Australia
15▼
Turkey (Türkiye)
15▼
Argentina
14▼

Rare diseases Gilead Sciences, Inc. works on

Each disease page lists every open trial, not only Gilead Sciences, Inc.'s, plus approved treatments.

Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a fast-growing cancer of the bone marrow in which immature white blood cells called blasts crowd out normal blood cells, causing fatigue, infections and bleeding...

How common: The National Cancer Institute's SEER program estimates 22,720 new US cases and 11,500 deaths in 2026, about 1.1% of new cancers, and 83,311 people were living with AML in 2023

Chronic Graft-versus-Host Disease

Chronic graft-versus-host disease is an immune-mediated complication after allogeneic stem cell or bone marrow transplant, in which donor immune cells attack the recipient's tissues.

How common: Affects 30-70% of patients who receive allogeneic hematopoietic stem cell transplant; approximately 14,000 new cases annually in the U.S

Chronic Inflammatory Demyelinating Polyneuropathy

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is an autoimmune disorder affecting the peripheral nerves, causing progressive weakness and impaired function in the legs and arms.

How common: About 2.8 per 100,000 people in a 2019 pooled analysis of 9 studies (Broers et al., Neuroepidemiology); NORD estimates 5 to 7 per 100,000, and NIH's GARD estimates about 50,000 people in the U.S

Cystic Fibrosis

Cystic fibrosis is an autosomal recessive genetic disorder affecting the CFTR protein, which normally regulates chloride transport.

How common: Nearly 40,000 children and adults in the U.S.; 1 in 2,500 to 3,500 births among Caucasians

Hodgkin Lymphoma

Hodgkin lymphoma is a cancer of the lymphatic system characterized by the presence of abnormal Reed-Sternberg cells.

How common: About 8,500 new cases per year in the U.S.; approximately 2.6 per 100,000 people

Homozygous Familial Hypercholesterolemia

Homozygous Familial Hypercholesterolemia is a severe genetic disorder causing extremely high cholesterol levels from birth, leading to early heart disease and cholesterol deposits in tendons and...

How common: Approximately 1 in 250,000 to 1 in 360,000 people globally

Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis is a chronic, progressive lung disease characterized by scarring (fibrosis) of lung tissue.

How common: About 100,000 people in the U.S., with 30,000 to 40,000 new cases a year (MedlinePlus Genetics)

Lupus Nephritis

Lupus nephritis is kidney inflammation caused by systemic lupus erythematosus (SLE), in which the immune system attacks the kidneys' filters and, without treatment, can lead to kidney failure.

How common: About 21 per 100,000 people in a Minnesota population study in 2015 (Lupus Midwest Network, 2022)

Multiple Myeloma

Multiple myeloma is a cancer of plasma cells, the white blood cells that make antibodies.

How common: About 36,000 new US diagnoses expected in 2026 and roughly 203,000 people living with it, which puts myeloma right at the edge of the US rare disease threshold; it is 1.7% of all new cancers (NCI SEER)

Multiple Sclerosis

Multiple sclerosis is a chronic autoimmune disease where the immune system attacks the protective myelin sheath surrounding nerve fibers in the brain and spinal cord.

How common: Approximately 1 million people in the U.S.; about 1 in 300

Myasthenia Gravis

Myasthenia gravis is a chronic autoimmune neuromuscular disorder causing muscle weakness and rapid fatigue.

How common: 1 in 5,000 people

Myelodysplastic Syndromes

Myelodysplastic syndromes are a group of blood cancers in which the bone marrow fails to produce enough healthy blood cells.

How common: 10,000 to 15,000 new cases annually in the U.S.; estimated 60,000 to 170,000 Americans living with MDS

Myelofibrosis

Myelofibrosis is a myeloproliferative neoplasm in which bone marrow develops scarring (fibrosis), leading to anemia, enlarged spleen, and abnormal blood cell counts.

How common: Approximately 0.5-1.5 cases per 100,000 people; median age of diagnosis is 65 years

Primary Biliary Cholangitis

Primary Biliary Cholangitis (PBC) is a chronic autoimmune liver disease in which the immune system mistakenly attacks the small bile ducts in the liver, leading to bile duct destruction and...

How common: About 14.6 per 100,000 people worldwide in a 2021 pooled analysis of 47 population studies, highest in North America (21.8 per 100,000) and lowest in the Asia-Pacific region (9.8 per 100,000)

Primary Central Nervous System Lymphoma

Primary central nervous system lymphoma (PCNSL) is a fast-growing lymphoma that starts in the brain, spinal cord, eyes or the membranes around them and usually stays there.

How common: About 5 new cases per million people a year in the US (Ono Pharmaceutical and Deciphera); more than half of patients are 60 or older

Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis (PSC) is a rare chronic liver disease characterized by inflammation and progressive scarring of the bile ducts, both inside and outside the liver.

How common: About 13.5 per 100,000 people in a 2024 pooled analysis of 12 population studies from North America, Europe, Asia and Oceania, with about 0.9 new cases per 100,000 people a year (Cooper et al., Inflamm Bowel Dis 2024); higher in Scandinavian countries; associated with IBD in 50-80% of PSC patients

Pulmonary Arterial Hypertension

Pulmonary arterial hypertension is a rare disease characterized by abnormally high blood pressure in the pulmonary arteries, causing progressive heart and lung damage.

How common: About 26 to 52 per million people in a Scottish national study, with about 7 new cases per million people each year (Peacock et al., European Respiratory Journal, 2007)

Systemic Sclerosis

Systemic sclerosis (scleroderma) is a rare autoimmune disease in which the immune system triggers scarring (fibrosis) of the skin and internal organs while also damaging small blood vessels.

How common: About 276 per million U.S. adults in a large Detroit-area study; about 19 new cases per million adults each year

Waldenström Macroglobulinemia

Waldenström Macroglobulinemia is a rare blood cancer in which malignant B-lymphocytes produce excessive amounts of a protein called macroglobulin (immunoglobulin M or IgM).

How common: Approximately 1,500 new cases per year in the United States; median age of diagnosis is 68 years

Where to get support

Patient groups can explain a diagnosis, point you to specialists and tell you about trials before they open. Gilead Sciences, Inc.'s own site is gilead.com, and our help paying for treatment page lists drugmaker programs and charity funds.

Questions about Gilead Sciences, Inc.