Last Updated: May 24, 2026

CLINICAL TRIALS PROFILE FOR CORGARD


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for CORGARD

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00670267 ↗ Oral Nadolol for the Treatment of Adults With Mild Asthma Completed Baylor College of Medicine Phase 1/Phase 2 2007-01-01 The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.
NCT00670267 ↗ Oral Nadolol for the Treatment of Adults With Mild Asthma Completed Sandler Program for Asthma Research Phase 1/Phase 2 2007-01-01 The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.
NCT00670267 ↗ Oral Nadolol for the Treatment of Adults With Mild Asthma Completed University of Houston Phase 1/Phase 2 2007-01-01 The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.
NCT00670267 ↗ Oral Nadolol for the Treatment of Adults With Mild Asthma Completed Invion, Inc. Phase 1/Phase 2 2007-01-01 The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.
NCT02021474 ↗ A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous Histamine Dihydrochloride for Migraine Prophylaxis Unknown status AgoneX Biopharmaceuticals, Inc. Phase 2 2015-09-01 This is a prospective multi-center, randomized, double-blind, two treatment period, placebo-controlled study in subjects with migraine headache requiring prophylactic treatment. The patients will be randomized to receive either histamine dihydrochloride sc or placebo (matching vehicle only) sc for 16 weeks. The safety and efficacy outcome measures will be assessed at selected dosing segments during the 16 week treatment phase and 4 weeks (week 20), 8 weeks (week 24) after the last Injection.
NCT02021474 ↗ A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous Histamine Dihydrochloride for Migraine Prophylaxis Unknown status BioHealthonomics Inc. Phase 2 2015-09-01 This is a prospective multi-center, randomized, double-blind, two treatment period, placebo-controlled study in subjects with migraine headache requiring prophylactic treatment. The patients will be randomized to receive either histamine dihydrochloride sc or placebo (matching vehicle only) sc for 16 weeks. The safety and efficacy outcome measures will be assessed at selected dosing segments during the 16 week treatment phase and 4 weeks (week 20), 8 weeks (week 24) after the last Injection.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CORGARD

Condition Name

Condition Name for CORGARD
Intervention Trials
Asthma 1
Migraine Prophylaxis 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for CORGARD
Intervention Trials
Migraine Disorders 1
Asthma 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for CORGARD

Trials by Country

Trials by Country for CORGARD
Location Trials
United States 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for CORGARD
Location Trials
Texas 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for CORGARD

Clinical Trial Phase

Clinical Trial Phase for CORGARD
Clinical Trial Phase Trials
Phase 2 1
Phase 1/Phase 2 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for CORGARD
Clinical Trial Phase Trials
Completed 1
Unknown status 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for CORGARD

Sponsor Name

Sponsor Name for CORGARD
Sponsor Trials
Baylor College of Medicine 1
Sandler Program for Asthma Research 1
University of Houston 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for CORGARD
Sponsor Trials
Other 3
Industry 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

CORGARD (Nadolol) Clinical Trials Update, Market Analysis and Projection

Last updated: April 25, 2026

What is CORGARD and what form is it in the market?

CORGARD is nadolol (a non-selective beta-adrenergic blocker) marketed in oral tablet form. It is an established, off-patent small-molecule product in most major markets, with clinical development largely limited to new formulations, label expansions, and comparative positioning rather than breakthrough mechanism claims.

What clinical trials data is available for CORGARD now?

No active, clearly attributable late-stage (Phase 3) clinical trial program specifically for CORGARD (nadolol) is identified from publicly indexed registries in a way that supports a current, drug-specific “pipeline update” narrative for investors. The nadolol class has ongoing academic and comparative research in cardiometabolic and cardiovascular settings, but these are not consistently tied to CORGARD-sponsored programs that materially change near-term market dynamics.

What is reliably actionable for business planning is the absence of a credible, near-term Phase 3-to-approval pipeline signal for nadolol as a brand-specific asset. This shifts the market outlook from “probability of new product approvals” to “brand share and defensibility” drivers (pricing, contracting, generic penetration, and substitution).

Clinical trial activity pattern (practical interpretation)

  • Brand-specific late-stage trials: not evidenced as an active, sponsor-driven, CORGARD-specific Phase 3 program that would support a near-term regulatory catalyst.
  • Class-level studies: may exist, but they do not typically reset nadolol commercialization without linked regulatory outcomes, label expansions, or reformulation exclusivity.

How does the legal and commercial reality shape the current pipeline?

For an established beta-blocker brand like CORGARD:

  • Generics are typically the primary competitive benchmark.
  • Any branded advantage is usually contract-driven (hospital formulary placement), guideline positioning (indications where nadolol is used), and supply reliability rather than patent-protected differentiation.
  • Near-term growth, if any, depends on retention of brand share, not on new molecular entity approvals.

Where does CORGARD get used clinically (demand drivers)?

CORGARD (nadolol) is used in cardiovascular indications where non-selective beta blockade is clinically appropriate, and in specialty settings where clinicians prefer nadolol dosing characteristics. Demand is therefore anchored to:

  • Persistent baseline cardiovascular prescribing
  • Specialty cardiology usage where nadolol fits formulary preferences
  • Substitution risk from lower-cost beta-blockers and generics

What is the market size and what does the competitive landscape look like?

A rigorous market size and forecasting model for CORGARD depends on (1) nadolol-specific sales capture by brand versus generic, and (2) regional prescribing and reimbursement dynamics. Public data typically reports the beta-blocker class or generic nadolol rather than “CORGARD brand only” granular revenues.

Given the lack of brand-specific late-stage catalyst and the strong expectation of generic competition for nadolol, the market outlook should be built on:

  • Total nadolol class demand (stable to modestly declining due to competitive substitution)
  • Brand share and pricing (volume erosion likely with ongoing substitution pressure)
  • Contracting and formulary dynamics (where brand can remain a preferred option despite generics)

Market projection framework: What matters most for CORGARD over the next 5 years?

Because CORGARD is a long-established product, the dominant drivers are commercial, not clinical. A practical projection separates the story into three components:

1) Total category demand (nadolol beta-blocker usage)

  • Likely stable to slightly down in most high-income markets due to prescribing migration and payer-driven cost optimization across beta-blockers.
  • Specialty retention can slow decline, but does not remove substitution risk.

2) Generic substitution rate

  • Continued erosion of brand share is expected unless CORGARD maintains strong payer access through contracts, switching barriers, or supply economics.
  • Competitors include both generic nadolol manufacturers and other beta-blockers with preferred formulary status.

3) Price-to-volume effect

  • Even if unit demand stabilizes, brand net sales tend to compress as payers negotiate or encourage generic substitution.

What is the base-case forecast for CORGARD?

A credible base case for a mature beta-blocker brand with generic competition is:

  • Net sales trend: modest decline to low-single-digit annual contraction in major markets
  • Volume trend: gradual erosion through generic substitution
  • Share risk: highest where formularies push “lowest acquisition cost”

This base-case is consistent with the absence of a brand-specific regulatory catalyst and the structural economics of generic penetration.

Upside cases (what would move the trajectory)?

Upside for CORGARD would likely come from one of these:

  • A meaningful label expansion or guideline shift that explicitly supports nadolol use over alternatives (requiring regulatory action and evidence)
  • A formulation lifecycle event that creates a short-term exclusivity or reimbursement advantage (if applicable)
  • A temporary supply disruption in generic channels that supports short-run brand retention (usually transient)

Absent evidence of a current brand-sponsored Phase 3 catalyst, upside is constrained and tends to be episodic rather than structural.

Downside cases (what would worsen the trajectory)?

Downside is tied to:

  • Faster formulary movement toward alternative beta-blockers
  • Intensified payer contracting for lowest-cost nadolol or other non-selective beta-blockers
  • Accelerated generic entry or price competition

Competitive benchmark: How does CORGARD sit versus other beta-blockers?

CORGARD competes primarily on:

  • Cost and availability versus generics
  • Clinician preference in select indications
  • Prescribing inertia versus payer-driven substitution

In most settings, the beta-blocker space is interchangeable clinically for many uses, which increases switching pressure.

Clinical trial implications for market projection

Because no active brand-specific late-stage pipeline is evident, clinical trial outcomes do not appear to drive a near-term approval-driven sales step-up. The market projection therefore relies on:

  • Prescriber demand stability
  • Payer behavior
  • Generic substitution pace

Actionable investment and R&D implications

For investors and business development

  • Treat CORGARD as a mature commercial asset: focus on brand share defense, payer access, and tender strategy rather than expecting molecular lifecycle re-acceleration.
  • Value is primarily tied to survivability of contracts and pricing power, not patent runway.

For R&D planners

  • Any R&D with the highest chance of impact would focus on:
    • Evidence generation tied to endpoints that influence payer and formulary decisions (not just academic outcomes)
    • Formulation improvements that can be tied to reimbursement or substitution resistance
    • Comparative effectiveness studies that reinforce nadolol’s positioning against alternatives

Key Takeaways

  • CORGARD is nadolol, a mature beta-blocker brand with commercialization dominated by generic competition economics, not by a visible near-term brand-specific Phase 3 pipeline catalyst.
  • A current “clinical trials update” does not support a near-term regulatory trigger that would materially change market trajectory.
  • Market projection should be built around brand share retention, contracting, and generic substitution pace, with a base case of modest annual net sales contraction in major markets.
  • Upside is constrained and most plausible via reimbursement-driven positioning or label/formulary shifts; downside follows faster payer switching and intensified price competition.

FAQs

  1. Is CORGARD expected to have a Phase 3 approval catalyst soon?
    No clear, brand-specific, sponsor-driven late-stage catalyst is evident from publicly indexed trial activity that would justify a near-term approval-based growth outlook.

  2. What drives CORGARD sales in a mature market?
    Payer contracting, formulary placement, and generic substitution pace, alongside baseline cardiovascular prescribing.

  3. How does generic competition typically impact a nadolol brand?
    It erodes brand share and compresses net pricing, often producing low-single-digit to modest annual declines even when total category use is stable.

  4. What would create meaningful upside for CORGARD?
    A regulatory label expansion, guideline shift that explicitly favors nadolol, or a reimbursement-linked differentiation that reduces substitution.

  5. How should market projections be modeled for CORGARD?
    Use a brand share and net price framework (contract and substitution dynamics) rather than an approval-driven pipeline framework.


References

[1] U.S. Food and Drug Administration. CORGARD (nadolol) prescribing information. FDA Drug Label Information. (Accessed via FDA label database).
[2] U.S. National Library of Medicine. ClinicalTrials.gov. Search results for nadolol/CORGARD-related interventional studies.
[3] Drugs@FDA. CORGARD (nadolol) application and labeling records. U.S. FDA.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.