Eli Lilly and Company

Eli Lilly and Company works on 37 rare diseases tracked on Trial Friend, including Amyotrophic Lateral Sclerosis, Bullous Pemphigoid, Cholangiocarcinoma and 34 more, with 13 recruiting clinical trials and 13 FDA-approved rare disease drugs.

Eli Lilly is a global pharmaceutical company with a growing presence in rare oncology, anchored by its 2019 acquisition of Loxo Oncology. Its rare disease portfolio includes Retevmo (selpercatinib) for RET-driven cancers such as medullary thyroid cancer and RET fusion-positive solid tumors, and Jaypirca (pirtobrutinib) for relapsed mantle cell lymphoma. Lilly also has active programs in ALS, pulmonary arterial hypertension, and other rare conditions.

Type
Diversified Pharma
Ticker
LLY
Headquarters
Indianapolis, United States
Founded
1876
Website
lilly.com
13
Active Rare Disease Trials
13
Approved Rare Disease Drugs
37
Rare Diseases in Portfolio
150
Years Active

Focus areas at Eli Lilly and Company

Within its broader pharmaceutical portfolio, Eli Lilly and Company has active clinical trial programs and drug development efforts across 37 rare diseases, including Amyotrophic Lateral Sclerosis, Bullous Pemphigoid, Cholangiocarcinoma, Cystic Fibrosis, Dermatomyositis, and 32 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 all active and recruiting studies sponsored by Eli Lilly and Company, 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.

Eli Lilly and Company is headquartered in Indianapolis, United States, founded in 1876, publicly traded under the ticker symbol LLY. 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.

Eli Lilly and Company Drug Pipeline

Eli Lilly and Company has 13 active clinical trials across 5 development stages, with 13 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of Eli Lilly and Company's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Eli Lilly and Company's pipeline
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3
Early Phase / Phase 13 trials
5
Phase 25 trials
Solid Tumor+1 more
Recruiting
Breast Cancer+1 more
Recruiting
3
Phase 33 trials
Type 2 Diabetes
Recruiting
Breast Cancer Female
Recruiting
1
Phase 4 / Post-Market1 trial
Chronic Lymphocytic Leukemia+1 more
Recruiting
1
Other1 trial
Chronic Kidney Disease(CKD)+2 more
Recruiting

Eli Lilly and Company Clinical Trials (13)

Active and recruiting clinical trials sponsored by Eli Lilly and Company, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about Eli Lilly and Company's trials
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RECRUITINGPHASE1, PHASE2Recently updatedNCT06721013

A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

Intervention: Pirtobrutinib, Placebo

The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo. The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.

Ages 18 Years+43 locations
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RECRUITINGPHASE1Recently updatedNCT07571200

A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)

Intervention: LY4256984

Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174). The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that will last at least 96 weeks.

Ages 18 Years - 80 Years11 locations
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ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT04088396

A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

Intervention: Baricitinib, Tocilizumab

The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.

Ages 1 Year - 17 Years55 locations
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ACTIVE NOT RECRUITINGPHASE2Recently updatedNCT04280081

A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation

Intervention: Selpercatinib

The reason for this study is to see if the study drug selpercatinib is safe and effective in participants in China with rearranged during transfection (RET) fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

Ages 18 Years+13 locations
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RECRUITINGPHASE3Recently updatedNCT06739122

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

Intervention: Dulaglutide

Type 2 Diabetes

The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.

Ages 10 Years - 17 Years51 locations
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ACTIVE NOT RECRUITINGPHASE1Recently updatedNCT04521686

Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

Intervention: LY3410738, Gemcitabine, Cisplatin, Durvalumab

CholangiocarcinomaChondrosarcomaGliomaAny Solid Tumor

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.

Ages 18 Years+33 locations
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RECRUITINGPHASE1, PHASE2Recently updatedNCT05768139

First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Intervention: STX-478, Fulvestrant, Ribociclib, Palbociclib, Letrozole, Anastrozole, Exemestane, Tamoxifen, Abemaciclib, Imlunestrant, Metformin

Breast CancerSolid Tumors, Adult

Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant, tamoxifen, or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.

Ages 18 Years+65 locations
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Eli Lilly and Company FDA-Approved Drugs (13)

Medications developed or marketed by Eli Lilly and Company that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
PEMETREXED DISODIUMAlimta
intravenous
Feb 4, 2004
FLORBETAPIR F 18
Radioactive Diagnostic Agent [EPC]
Amyvid
intravenous
Apr 6, 2012
RAMUCIRUMAB
Vascular Endothelial Growth Factor Receptor 2 Antagonist [EPC]
CYRAMZA
intravenous
Apr 21, 2014
RALOXIFENE HYDROCHLORIDEEvista
oral
Dec 9, 1997
TERIPARATIDE
Parathyroid Hormone Analog [EPC]
Forteo
subcutaneous
Nov 26, 2002

Eli Lilly and Company Trial Locations

Eli Lilly and Company clinical trials are running at 422 sites in 27 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
132▼
Germany
77▼
Spain
40▼
Italy
23▼
Japan
22▼
China
17▼
France
16▼
Poland
13▼
United Kingdom
13▼
Mexico
10▼
Canada
9▼
South Korea
8▼

Rare Disease Focus Areas (37)

Diseases targeted by Eli Lilly and Company's clinical trial and drug development programs

Amyotrophic Lateral SclerosisNeurological & Neuromuscular

Amyotrophic lateral sclerosis is a progressive neurodegenerative disease destroying motor neurons in the brain and spinal cord. This causes progressive weakness and paralysis of voluntary muscles whil...

Prevalence: About 5,000 new cases per year in the U.S.; approximately 16,000 Americans living with ALS at any given time
Bullous PemphigoidDermatologic

Bullous pemphigoid is an autoimmune blistering disorder caused by autoantibodies against basement membrane proteins, particularly BP180 and BP230. The condition leads to formation of large fluid-fille...

Prevalence: Approximately 2-23 per million people per year; incidence increases sharply with age
CholangiocarcinomaRare Cancers

Cholangiocarcinoma is a rare and aggressive cancer that forms in the bile ducts, the thin tubes that carry digestive fluid (bile) from the liver to the small intestine. It can occur inside the liver (...

Prevalence: About 8,000 new cases per year in the U.S.; rising incidence worldwide
Cystic FibrosisPulmonary & Respiratory

Cystic fibrosis is an autosomal recessive genetic disorder affecting the CFTR protein, which normally regulates chloride transport. Defective CFTR causes thick, sticky secretions in the lungs and dige...

Prevalence: About 30,000 people in the U.S.; 1 in 2,500 to 3,500 births among Caucasians
DermatomyositisAutoimmune & Inflammatory

Dermatomyositis is a rare autoimmune inflammatory disease causing muscle weakness and distinctive skin rashes, particularly over joints. It involves inflammation of muscles and skin blood vessels. Abo...

Prevalence: Approximately 1-10 cases per million people; juvenile-onset incidence about 0.4 cases per 100,000 children
Desmoplastic Small Round Cell TumorRare Cancers

Desmoplastic small round cell tumor is a rare aggressive sarcoma characterized by EWSR1-WT1 fusion and dense desmoplasia. Most commonly arising in the peritoneum of adolescents and young adults, the c...

Prevalence: Fewer than 200 cases per year in the U.S.; occurs at any age but most common age 15-35

Patient Resources

Organizations and resources related to Eli Lilly and Company's rare disease focus areas

Frequently Asked Questions About Eli Lilly and Company

Common questions about Eli Lilly and Company's rare disease programs, clinical trials, and treatments.