VIOKACE

(Pancrelipase)

ApprovedProtein / enzyme

DDigestive Care, Inc.

VIOKACE is one of 106 small molecule programs targeting Acute Pancreatitis. It is currently in Approved.

Indications

Total Trials

Active Trials

105

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Acute PancreatitisRecruiting

Pancreatic AdenocarcinomaTerminated

Irritable Bowel SyndromeActive, not recruiting

Celiac DiseaseActive, not recruiting

Acute PancreatitisApproved

Recruiting

Pancreatic AdenocarcinomaPhase 2

Terminated

Irritable Bowel SyndromeApproved

Active, not recruiting

Celiac DiseaseApproved

Active, not recruiting

Competition

Competitive Landscape

47 competitors in Pancreatic Adenocarcinoma

#DrugCompanyPhaseTrials

Gemzar

Johnson & Johnson

Phase 3

45 2

Xeloda

EEngelhard Arzneimittel GmbH & Co.KG

Approved

11 3

Abraxane

Bristol-Myers Squibb

Phase 3

24 4

Taxol

Eloxatin

11 6

VIOKACE

DDigestive Care, Inc.

Approved

2 7

Mfolfirinox

Incyte

Phase 3

7 8

Opdivo

Bristol-Myers Squibb

Phase 2

6 9

Imfinzi

AstraZeneca

Phase 2

4 10

Gemzar

Johnson & Johnson

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Pancreatic Adenocarcinoma

NCT04098237

Q3 2027

Post-ApprovalRecruiting

Acute Pancreatitis

NCT06477159

Clinical

Trials by Indication[1]

Cystic Fibrosis6 trials

Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Completed·MMylan Inc.··NCT01427712·24 enrolled

Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis

Completed·UUniversity of Colorado, Denver·N/A·NCT02372383·31 enrolled

A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Completed· AbbVie logo

AbbVie·Phase 4·NCT03924947·36 enrolled

Show 3 more trials

Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00510484·35 enrolled

Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00690820·17 enrolled

Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00775528·19 enrolled

Pancreatic Cancer2 trials

PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer

Terminated·—·Phase 1/2·NCT02985801·16 enrolled

A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)

Terminated· AbbVie logo

AbbVie·Phase 4·NCT03859869·1 enrolled

Pancreatic Adenocarcinoma2 trials

Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency

Active, not recruiting·—·Phase 2·NCT04098237·36 enrolled

Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma

Terminated·—·Phase 2·NCT03469258·4 enrolled

Chronic Pancreatitis2 trials

Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis

Withdrawn·—·Phase 2·NCT02706236

A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00414908·52 enrolled

Celiac Disease1 trial

Pancreatic Enzyme Supplementation for Celiac Disease

Terminated·—·Phase 4·NCT02475369·21 enrolled

4 more indications

Irritable Bowel Syndrome1 trial

Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

Completed·AAmerican Academy of Family Physicians·Phase 4·NCT01641341·61 enrolled

Aspiration1 trial

Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control

Terminated·DDigestive Care, Inc.·Phase 4·NCT00744250·3 enrolled

Pancreatic1 trial

Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)

Terminated·DDigestive Care, Inc.·N/A·NCT00749099·11 enrolled

Acute Pancreatitis1 trial

Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency

Recruiting·OOhio State University·Phase 4·NCT06477159·60 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 30, 2009

CREON

BLA BLA020725

Mar 1, 2012

VIOKACE

BLA BLA022542

May 17, 2012

PERTZYE

BLA BLA022175

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Pancrelipase. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pancrelipase compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pancrelipase. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA022175). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Digestive Care, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Approved[1]
Company: DDigestive Care, Inc.

VIOKACE

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Trials by Indication[1]

Cystic Fibrosis6 trials

Pancreatic Cancer2 trials

Pancreatic Adenocarcinoma2 trials

Chronic Pancreatitis2 trials

Celiac Disease1 trial

Irritable Bowel Syndrome1 trial

Aspiration1 trial

Pancreatic1 trial

Acute Pancreatitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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