CLINICAL TRIALS PROFILE FOR PRANDIN

All Clinical Trials for PRANDIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	National Institutes of Health (NIH)	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	Novo Nordisk A/S	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	Washington University School of Medicine	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	Arbelaez, Ana Maria	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.

Clinical Trial Conditions for PRANDIN

Condition Name

Condition Name for PRANDIN
Intervention	Trials
Sickle Cell Disease	1
Cystic Fibrosis Related Diabetes	1
Diabetes Mellitus, Type 2	1
Pancreatic Insufficiency	1

Condition MeSH

Condition MeSH for PRANDIN
Intervention	Trials
Diabetes Mellitus	2
Prediabetic State	1
Glucose Intolerance	1
Fibrosis	1

Clinical Trial Locations for PRANDIN

Trials by Country

Trials by Country for PRANDIN
Location	Trials
United Kingdom	2
United States	2

Trials by US State

Trials by US State for PRANDIN
Location	Trials
Texas	1
Missouri	1

Clinical Trial Progress for PRANDIN

Clinical Trial Phase

Clinical Trial Phase for PRANDIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for PRANDIN
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for PRANDIN

Sponsor Name

Sponsor Name for PRANDIN
Sponsor	Trials
Washington University School of Medicine	1
Arbelaez, Ana Maria	1
University Hospital Birmingham	1

Sponsor Type

Sponsor Type for PRANDIN
Sponsor	Trials
Other	4
Industry	2
NIH	2

PRANDIN Market Analysis and Financial Projection

Last updated: May 4, 2026

PRANDIN (repaglinide): Clinical-Trials Update, Market Analysis, and Projection

What is PRANDIN and what is its current clinical-trials status?

PRANDIN is the brand name for repaglinide, an oral, short-acting meglitinide insulin secretagogue used to treat type 2 diabetes mellitus (T2DM). Repaglinide works by stimulating pancreatic insulin release in a glucose-dependent manner.

Clinical trials: status of new development

No meaningful, active Phase 2/3 development program tied to PRANDIN (repaglinide) was identified based on the current availability of trial activity in public registries and the product’s established, off-patent status in most major markets. The practical consequence for investors is that “clinical-trials updates” are now largely limited to:

• Bioequivalence studies for generic manufacturers
• Real-world evidence and observational analyses
• Formulation or dosing regimen studies that do not reset exclusivity

Regulatory lifecycle and exclusivity

Repaglinide is an established molecule with generic competition in multiple jurisdictions, which materially constrains the probability of new, brand-level clinical readouts translating into exclusivity extension.

Implication for R&D strategy: Any incremental clinical activity is most likely to be led by generic entrants (BE and bridging) rather than by the original brand holder, and it typically does not create a new IP moat.

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Who buys PRANDIN and why does it still get prescribed?

PRANDIN’s retention in therapy follows a stable pattern for short-acting secretagogues:

• Patients needing meal-time flexibility may prefer short-acting agents
• It is used when clinicians want a rapid onset aligned to meals
• It can be considered when cost is a driver (generic availability)

Competitive positioning (therapeutic class)

PRANDIN competes primarily with:

• Sulfonylureas (e.g., glipizide, glyburide)
• DPP-4 inhibitors
• GLP-1 receptor agonists
• Basal insulins
• Other meglitinides (the class is small; repaglinide is often a key listed agent)

Clinically, repaglinide’s key tradeoff is:

• Efficacy: glucose lowering via insulin secretion
• Safety: hypoglycemia risk is class-related and generally tracked versus newer agents with lower hypoglycemia risk profiles

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How big is the PRANDIN market today?

A precise market-size number for “PRANDIN brand sales” is constrained by public data granularity, since PRANDIN sales are typically embedded inside broader repaglinide / insulin secretagogue categories and are widely competed by generics.

Actionable market conclusion: The market exists, but it behaves like a mature, generic-exposed therapy:

• Brand share depends on local formulary access and pricing
• Growth is limited and mostly reflects population and diabetes prevalence rather than share gains
• Demand is sensitive to payer cost controls and step-therapy design

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What do pricing and formulary dynamics imply for the near-term trajectory?

In mature, off-patent oral diabetes classes, price and access usually follow these rules:

• Generic entry compresses price within 6 to 24 months of meaningful launches
• Formularies favor lowest net cost unless clinical preference is explicit
• Physician preference often sustains volume but not brand economics

For PRANDIN, this translates into:

• Stable or slowly declining volume over time in many markets
• Narrowing brand profitability relative to generics
• Higher dependence on specific payer dynamics and local contracting

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Market projection: what should investors assume over 3–5 years?

A reasonable forward model for PRANDIN brand economics in most major geographies assumes:

• Volume: low single-digit decline or flat-to-slightly negative growth
• Revenue: decline driven by price compression and share reallocation to cheaper products
• Share: stable in specific formularies but not expanding materially

Projection framework (brand-level economics, not molecule-level incidence)

Horizon	Volume outlook (brand)	Net revenue outlook (brand)	Primary drivers
12-24 months	Flat to slight decline	Decline	Generic pricing, formulary tightening
2-3 years	Slight decline	Further decline	Contract cycles, rebate structures
3-5 years	Mid-single-digit decline	Mid to high-single-digit decline	Continued substitution and cost controls

Interpretation: PRANDIN brand value is likely to be dominated by account access and pricing leverage, not by innovation.

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Is there any clinical upside that could change the outlook?

For a mature molecule, clinical upside that meaningfully changes brand economics would require one of the following:

• A demonstrable subgroup benefit strong enough to change guideline or payer behavior
• A new formulation with differentiated dosing or adherence outcomes that payers accept as value
• A new combination strategy with distinct payer recognition

No such brand-level differentiators were identified as a current driver in the available clinical activity pattern. Most ongoing work around repaglinide is expected to be non-exclusivity oriented (BE, observational, or minor regimen studies).

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What does this mean for competitive strategy?

For a brand owner or brand investor, the highest-probability moves are not “new trials” but operational and contracting:

• Payer strategy: defend formulary placement via net price and rebate strategy
• Channel: maintain script flow in markets where switching friction is higher
• Compliance and safety positioning: emphasize appropriate use to reduce hypoglycemia concerns and limit payer pushback

For a generic or entrant, the strategy is the reverse:

• Win contracts on lowest net cost
• Run BE and compliant labeling positioning
• Use physician-facing education on meal-based dosing

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Key Takeaways

• PRANDIN is repaglinide, a mature T2DM therapy with stable clinical use but generic-driven economics.
• Active brand-level Phase 2/3 innovation is not evident in the current public clinical-trial activity pattern; practical trial activity is mostly BE/bridging and observational work.
• Market growth is limited and brand performance is driven by formulary access and net pricing, not therapeutic breakthroughs.
• Over 3–5 years, the most likely brand trajectory is flat-to-declining volume and declining revenue due to persistent generic substitution.

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FAQs

1) What class of diabetes drug is PRANDIN?

PRANDIN (repaglinide) is a meglitinide insulin secretagogue that stimulates pancreatic insulin release.

2) Why does PRANDIN remain prescribed despite generic competition?

Clinicians use it for meal-time dosing and for patients where cost and dosing flexibility align with therapeutic goals.

3) What limits PRANDIN’s market growth?

Generic pricing pressure, payer cost controls, and substitution by other oral agents with lower hypoglycemia risk profiles.

4) What type of clinical studies dominate for repaglinide now?

Primarily bioequivalence studies for generic manufacturers, plus observational analyses.

5) What is the most likely 3–5 year direction for PRANDIN brand revenue?

A declining trend driven by ongoing price compression and formulary substitution.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. Repaglinide search results. https://clinicaltrials.gov/
[2] DailyMed. PRANDIN (repaglinide) prescribing information. https://dailymed.nlm.nih.gov/
[3] World Health Organization. ATC/DDD methodology and classification (meglitinides/repaglinide ATC context). https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/development-of-guidelines/atc-ddd-system