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lipase

Generic: lipase·Brand: Creon, Pancreaze, Pertzye, Zenpep

lipase: developed by 1 company · 2 clinical trials tracked · 1 FDA decision.

lipase evidence translation

What we can confirm

1 FDA record · 2 tracked trials

What it means

Source-backed records connect lipase to ABBV; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could lipase → ABBV affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Fibrosing Colonopathy

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
AbbVie Inc. (ABBV)
Fibrosing Colonopathy
—
Clinical Trials (2)

A Phase 2a, Randomized, Open-Label, Active-Controlled, Crossover Study to Evaluate Safety and Explore Efficacy of Different Doses of New Lipase NHS7108 Administered Orally in Participants With Exocrine Pancreatic Insufficiency- EPIC

NCT07559175·Phase 2
Not yet recruiting

Primary endpoint: Primary Objectives: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.

InterventionalRandomizedopen66 targetStarted 2026-04Completion 2027-0930 sites · Bulgaria, Hungary, Italy, Poland…Aimmune Nestlé Health Science US R&D, LLC

A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study)

NCT01652157·ABBV
Terminated

Primary endpoint: Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ZENPEP

Observational17 targetStarted 2012-07Completion 2020-0450 sites · United StatesAbbVie
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE CREON ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.(ABBV)FDA ↗
BLA020725Type 7 - Drug Already Marketed without Approved NDAPriorityOralCapsule, Delayed Release

Frequently asked questions

Who is developing lipase?

lipase is being developed by AbbVie Inc..

How many clinical trials involve lipase?

BioSniper tracks 2 clinical trials involving lipase.

What is lipase's latest FDA decision?

The most recent tracked FDA decision for lipase is Approval for 1 INDICATIONS AND USAGE CREON ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients., dated April 30, 2009.