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Boehringer Ingelheim

Total Trials
12
Recruiting
12
Phases
Phase 1, Phase 2, Phase 1, Phase 2, Phase 3

Boehringer Ingelheim is Germany's largest privately-owned pharmaceutical company, headquartered in Ingelheim am Rhein. As a family-owned company reinvesting a significant portion of revenues into R&D, Boehringer Ingelheim has built a reputation for sustained investment in underserved disease areas. The company's research priorities include cardio-renal-metabolic disease, respiratory medicine and immunology, oncology, and neurological conditions. Boehringer Ingelheim was among the first to launch an SGLT2 inhibitor (empagliflozin/Jardiance, developed with Eli Lilly), and remains one of the most active sponsors of cardiorenal trials globally.

Empagliflozin's clinical trial program — the EMPA-REG OUTCOME, EMPEROR-Reduced, EMPEROR-Preserved, EMPA-KIDNEY, and ongoing trials — has established SGLT2 inhibition as a cardiovascular and renal protective drug class across heart failure with reduced and preserved ejection fraction, chronic kidney disease (with and without diabetes), and type 2 diabetes. These findings have changed international treatment guidelines and spawned dozens of combination and mechanism-extension trials. Boehringer Ingelheim also co-developed nintedanib (Ofev), the leading anti-fibrotic for idiopathic pulmonary fibrosis and systemic sclerosis-associated ILD.

In oncology, Boehringer Ingelheim runs active trials on afatinib (Gilotrif) in EGFR-mutant NSCLC, investigational bispecific antibodies, and KRAS inhibitor combinations. The immunology and respiratory pipeline features active trials on spesolimab (an IL-36 receptor inhibitor) for generalized pustular psoriasis — an ultra-rare and life-threatening skin condition for which spesolimab received breakthrough designation — and dupilumab-class cytokine programs for asthma and atopic disease. Boehringer Ingelheim operates research sites across 130 countries.

Frequently Asked Questions — Boehringer Ingelheim

What heart failure and kidney disease trials does Boehringer Ingelheim run?
Boehringer Ingelheim has one of the most active cardiorenal clinical trial programs of any pharmaceutical company, centered on empagliflozin (Jardiance, co-developed with Eli Lilly). Landmark completed trials include EMPA-REG OUTCOME (cardiovascular risk reduction in type 2 diabetes), EMPEROR-Reduced (heart failure with reduced ejection fraction), EMPEROR-Preserved (heart failure with preserved ejection fraction — the first trial to show benefit in this population), and EMPA-KIDNEY (chronic kidney disease with and without diabetes). Ongoing trials are exploring empagliflozin in acute heart failure hospitalization, earlier-stage CKD, and in combination with other cardiorenal protective agents. The company also has novel mineralocorticoid receptor antagonists and aldosterone synthase inhibitors in Phase 2 trials for resistant hypertension and cardiac fibrosis.
What is nintedanib and what lung diseases does Boehringer Ingelheim study it in?
Nintedanib (Ofev) is an intracellular kinase inhibitor targeting VEGFR, PDGFR, and FGFR — growth factor receptor pathways involved in fibrogenesis. It is FDA-approved for idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), and other progressive fibrosing ILDs. Boehringer Ingelheim runs Phase 3 and Phase 4 trials evaluating nintedanib in combination with anti-inflammatory agents for SSc-ILD, in pediatric IPF (an extremely rare condition with no approved therapies), in post-COVID fibrotic lung disease, and in other fibrosing conditions including chronic hypersensitivity pneumonitis.
Does Boehringer Ingelheim conduct trials in rare skin diseases?
Yes. Boehringer Ingelheim has developed spesolimab (Spevigo), a monoclonal antibody targeting the IL-36 receptor, which received FDA approval for generalized pustular psoriasis (GPP) — a rare, potentially life-threatening inflammatory skin disease characterized by widespread pustular flares. GPP affects an estimated 1–2 people per million in the US and has historically had no approved treatments. Boehringer Ingelheim is running trials of spesolimab in GPP prevention (Phase 3 EFFISAYIL-2), pediatric GPP, palmoplantar pustulosis, and psoriasis with pustular features — a program that represents a significant advance in rare dermatology.

Clinical Trials by Boehringer Ingelheim

NCT05471856 Phase 1
Recruiting

A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)

Solid Tumors
NCT07224425 Phase 1
Recruiting

A Study of BI 3810944 in Patients With Advanced Cancer

Solid Tumours
NCT05882058 Phase 2
Recruiting

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

Small Cell Lung Carcinoma
NCT07754474 Phase 1
Recruiting

A Study to Test How Well Different and Multiple Doses of BI 3034701 Are Tolerated in People Living With Overweight or Obesity

Overweight
NCT07607678 Phase 1
Recruiting

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab

Advanced Solid Cancer
NCT07843940 Phase 1, Phase 2
Recruiting

A Study to Test Obrixtamig in Combination With Pumitamig in People With Advanced Small Cell Lung Cancer (Dareon®-Rosetta35)

Extensive-stage Small Cell Lung Carcinoma
NCT06745297 Phase 1
Recruiting

A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated

Healthy
NCT07201922 Phase 3
Recruiting

A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

Familial Pulmonary Fibrosis
NCT07366034 Phase 3
Recruiting

A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)

Fibrosing Interstitial Lung Disease
NCT07908004 Phase 1
Recruiting

A Study to Test How Well Different Doses of BI 3821001 Are Tolerated by Healthy People

Healthy
NCT06424288 Phase 3
Recruiting

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

Heart Failure
NCT07355296 Phase 2
Recruiting

PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

Proteinuric Kidney Diseases
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