Boehringer Ingelheim Human Pharma Clinical Pipeline
Selection of projects in February 2024.
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Phase 3
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Phase 3 studies are designed to confirm the data of Phase 2 studies for an investigational drug. Large numbers of participants with the disease are generally involved to obtain safety and efficacy data to evaluate the overall benefit-risk relationship of an investigational drug to provide an adequate basis for regulatory approvals. Given the size of these studies and to ensure a representative sample of patients, they are often conducted across several countries.
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Phase 2
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Phase 2 studies are usually designed to begin to evaluate the efficacy of an investigational drug in a higher number of participants with the disease, and often used to obtain dose-ranging information. Safety also continues to be assessed during this phase.
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Phase 1
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Phase 1 studies are usually designed with an emphasis on the assessment of safety and tolerability of an investigational drug in a small group of people for the first time. It can include healthy participants or participants with the disease.
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† Being investigated in combination with other therapies.
* Anchored in external partnership or acquisition.
** Prevention of HF post MI
Lightbulb: Breakthrough Therapy/Device Designation or equivalent granted by US, EU or Japan.
Fast Track: Fast Track Designation granted by the U.S. Food and Drug Administration
Indication abbreviations:
BTC: Advanced biliary tract cancer
CD: Crohn’s disease
CIAS: Cognitive impairment associated with schizophrenia
CSPH: Clinically significant portal hypertension
DDLPS: Dedifferentiated liposarcoma
DR: Diabetic Retinopathy
LC-NEC: Large cell neuroendocrine carcinoma
PG: Pyoderma gangrenosum
FSGS: Focal segmental glomerulosclerosis
GPP: Generalized pustular psoriasis
HF: Heart failure
HS: Hidradenitis suppurativa
IPF: Idiopathic pulmonary fibrosis
MASH: Metabolic dysfunction-associated steatohepatitis
MDD: Major depressive disorder
NSCLC: Non-small-cell lung cancer
MI: Myocardial infarction
NS: Netherton syndrome
nCFB: non-cystic fibrosis bronchiectasis
PPF: Progressive pulmonary fibrosis
PTSD: Post-traumatic stress disorder
SSc: Systemic sclerosis
ep-NEC: Extra-pulmonary neuroendocrine carcinoma
SCLC: Small-cell lung cancer