CLINICAL TRIALS PROFILE FOR MIDAMOR

All Clinical Trials for MIDAMOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00709137 ↗	Spironolactone Versus Amiloride as an Add on Agent in Resistant Hypertension	Withdrawn	VA Salt Lake City Health Care System	N/A	2008-10-01	Joint National Committee 7 (JNC-7) defines resistant hypertension as a persistent elevation of blood pressure (BP) above goal - ≥ 140/90 mm Hg for the general hypertensive population or ≥ 130/80 mm Hg for persons with diabetes mellitus or chronic kidney disease - for at least three months despite treatment with three or more optimally dosed antihypertensive agents, including a diuretic. The exact prevalence of resistant hypertension is uncertain but may include 5-20% of hypertensive persons in primary care settings and 15-35% of the older, higher cardiovascular risk hypertensive patients incorporated into recent clinical trials of antihypertensive therapy. Observational studies demonstrate that patients with resistant hypertension experience a higher rate of cardiovascular and renal target organ damage such as left ventricular hypertrophy, microalbuminuria, and renal insufficiency and more cardiovascular disease (CVD) events than patients whose hypertension is well-controlled. Additionally, resistant hypertension patients may be subjected to the considerable expense of multiple office visits, diagnostic testing for secondary causes of hypertension, and referral to hypertension specialists. Because multiple factors can contribute to resistant hypertension, an explicit, sequential approach to evaluation and management is essential to optimize blood pressure, reduce cardiorenal morbidity and mortality, and avoid unnecessary expense. A number of observational studies have suggested the potential efficacy of both spironolactone and amiloride when added to a 3 drug antihypertensive regimen, but to date no randomized study has directly compared the two agents. The goal of this study is to determine whether spironolactone or amiloride is the more effective fourth agent to add to a three drug regimen in patients with resistant hypertension.
NCT01095133 ↗	Do Acid Sensing Ion Channels Contribute to Heartburn?	Completed	University of North Carolina, Chapel Hill	Phase 1	2010-03-01	The purpose of this research study is to learn about whether treating the esophagus with amiloride reduces either the frequency or the time to onset of acid-induced heartburn in patients with nonerosive reflux disease. In particular, we are looking at people who have either had complete relief while using a Proton Pump Inhibitor (PPI) or who have only had some relief of symptoms while on a PPI.
NCT01802489 ↗	Amiloride Clinical Trial In Optic Neuritis	Completed	Multiple Sclerosis Society of Great Britain and Northern Ireland	Phase 2	2013-02-01	Optic neuritis (ON) is a common event in Multiple Sclerosis (MS), and causes significant loss of nerve cells in the eye, resulting in poor vision. Optic neuritis also provides a sensitive way of testing the effectiveness of drugs that may help protect from loss of nerve cells in ON and therefore in MS. The investigators have identified through laboratory and early clinical research in humans that amiloride (a water tablet already in use) may be a drug that can be of benefit in optic neuritis by protecting from loss of nerves cells, ie a neuroprotective drug. The purpose of this study is to assess the efficacy of amiloride as a neuroprotective drug in optic neuritis

Clinical Trial Conditions for MIDAMOR

Condition Name

Condition Name for MIDAMOR
Intervention	Trials
Hypertension	2
Plasma Pharmacokinetics of Amiloride Nasal Spray	1
Proteinuria	1

Condition MeSH

Condition MeSH for MIDAMOR
Intervention	Trials
Hypertension	2
Neuritis	1
Multiple Sclerosis	1

Clinical Trial Locations for MIDAMOR

Trials by Country

Trials by Country for MIDAMOR
Location	Trials
United States	4
United Kingdom	1

Trials by US State

Trials by US State for MIDAMOR
Location	Trials
Utah	2
New Mexico	1
North Carolina	1

Clinical Trial Progress for MIDAMOR

Clinical Trial Phase

Clinical Trial Phase for MIDAMOR
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for MIDAMOR
Clinical Trial Phase	Trials
Completed	2
Withdrawn	1
Recruiting	1

Clinical Trial Sponsors for MIDAMOR

Sponsor Name

Sponsor Name for MIDAMOR
Sponsor	Trials
Dialysis Clinic, Inc.	1
University of Pittsburgh	1
University of New Mexico	1

Sponsor Type

Sponsor Type for MIDAMOR
Sponsor	Trials
Other	8
Industry	1
U.S. Fed	1

MIDAMOR (Amiloride): Clinical Trials Update, Market Analysis, and Projection

Last updated: May 3, 2026

What is MIDAMOR and what is its active ingredient?

MIDAMOR is the brand name for amiloride, an orally active epithelial sodium channel (ENaC) inhibitor used primarily as a potassium-sparing diuretic. MIDAMOR is marketed for indications related to edema and hypertension and is also used off-label in certain renal tubule disorders where ENaC blockade is clinically relevant.

Regulatory status (U.S.)

• Drug type: Small-molecule
• Active ingredient: amiloride
• Typical prescribing pattern: generics dominate the amiloride market; branded MIDAMOR is a legacy product with limited modern trial activity relative to newer therapeutics.

What does the clinical-trials landscape show for MIDAMOR?

There is no evidence of active, late-stage, pivotal clinical development programs for MIDAMOR as a brand. Amiloride is widely used, and clinical activity tends to be:

• Academic or mechanistic studies
• Investigator-led trials
• Combination studies aimed at specific disease hypotheses (often in oncology or renal physiology)
• Repurposing trials with older assets rather than brand-new regulatory pathways

Practical implication for investors and R&D

• MIDAMOR should be treated as a low-R&D-growth, high-utilization, patent-limited asset rather than a platform with a near-term pipeline catalyst.
• Any near-term value upside comes from formulation lifecycle management, label expansion opportunities, or geographies where branded supply remains relevant, not from fresh Phase 3 readouts.

What is the addressable market for amiloride (MIDAMOR) and how is demand shaped?

The market is driven by:

• Chronic management of edema and hypertension, where diuretic regimens remain standard of care
• Competitive pricing pressure from multiple generic manufacturers
• Therapeutic switching within diuretic classes based on cost, tolerability, and clinician preference

Market structure (commercial reality)

• Generic-led: Amiloride is off-patent; branded MIDAMOR faces pricing competition from generics.
• Class substitution risk: Patients on diuretics can be shifted to alternative potassium-sparing agents or different diuretic strategies based on local formularies.
• Low expectation of brand premium: The branded product typically captures a smaller share unless a payer or provider ecosystem specifically favors it.

How big is the MIDAMOR/amiloride market in practice?

A precise, brand-specific global TAM/SAM/SOM calculation for MIDAMOR alone is not a reliable basis for forecasting because:

• IMS-style brand sales data are usually proprietary
• Public sources generally aggregate “amiloride” rather than “MIDAMOR” specifically
• Generic substitution blunts brand share signals

A business-useful approach is to model the amiloride class consumption and then allocate a brand share based on payer and channel dynamics.

Demand drivers and constraints

Upside drivers

• Persistent need for potassium-sparing diuretic options in chronic edema/hypertension
• Guideline continuity for diuretic-based regimens in appropriate patients
• Occasional renewed attention to ENaC biology in translational research that can support sustained prescribing

Downside constraints

• Aggressive generic pricing pressure
• Limited brand differentiation in a mature, off-patent market
• Low probability of regulatory catalyst scale that would materially shift prescribing volumes

What clinical trial signals matter for amiloride right now?

For amiloride, the commercially relevant trial signals are not whether a study exists, but whether it changes:

• Regulatory status (new label)
• Standard of care (broad guideline adoption)
• Utilization channel (payer coverage that expands use)
• Product form factors (new dosage forms that reduce switching)

Given MIDAMOR’s established role and the typical nature of ongoing amiloride research (often not label-changing), the most likely near-term outcome is incremental evidence accumulation, not a new blockbuster indication.

Market projection: what trajectory should you assume for MIDAMOR?

For a mature, off-patent oral drug with high generic penetration, the baseline projection typically follows:

• Volume stability to modest decline as prescribers and payers favor lowest-cost generics
• Price erosion outpacing any modest volume gains
• Brand MIDAMOR share holding only if branded supply is favored in specific channels

Base-case projection framework

Because there is no evidence of an imminent, label-changing clinical catalyst for MIDAMOR, the forecast should assume:

1. No major indication expansion
2. Continued generic substitution
3. Modest market growth driven by underlying chronic disease prevalence, partially offset by switching dynamics

Expected commercial path (base case)

• Unit volumes: stable to slightly down
• Net sales (brand): down or flat in real terms due to pricing compression
• Profit pool: constrained by generic competitive intensity and distribution economics

How should an investor or R&D decision-maker evaluate MIDAMOR vs. alternatives?

MIDAMOR competes within diuretic therapy ecosystems where:

• Clinician preference and payer formularies dominate
• Drug-to-drug differentiation is limited once generics exist
• Therapeutic value is largely understood; new evidence rarely changes adoption quickly

Actionable decision lens

• If you are assessing near-term revenue, treat MIDAMOR as a cash-flow/defensive asset, not a growth engine.
• If you are assessing R&D ROI, any strategy must be tied to:
  • A new regulatory endpoint (label expansion with clear efficacy and safety differentiation)
  • A proprietary formulation that avoids simple generic substitution
  • A combination that becomes the reimbursed standard

Key constraints in the patent-and-development economics

MIDAMOR is a legacy brand. In mature markets with off-patent actives:

• Patent life is either expired or not a primary driver of commercial upside
• Clinical trial costs rarely translate into sustainable brand premium unless reimbursement or standard-of-care changes
• Trial design must produce label-changing, guideline-relevant outcomes to matter economically

Key Takeaways

• MIDAMOR is amiloride, an ENaC inhibitor with a mature diuretic role in chronic edema and hypertension.
• The clinical-trials environment for amiloride typically shows incremental or repurposing research, with low likelihood of near-term label-changing outcomes for the MIDAMOR brand.
• The market is generic-led and forecast should assume pricing compression and stable-to-declining brand share, absent a new indication or proprietary formulation breakthrough.
• Any investment or R&D plan tied to MIDAMOR economics must be built around regulatory differentiation (new label) or true product differentiation that changes reimbursement behavior.

FAQs

1. Is MIDAMOR currently undergoing Phase 3 development for a new indication?
   The clinical-development signal for MIDAMOR as a brand does not indicate an active, label-changing Phase 3 program.

2. Why does generic competition dominate MIDAMOR sales?
   Amiloride is widely available as a low-cost generic, and payers typically favor lowest-cost therapeutics once efficacy and safety are established.

3. What trial outcomes would most improve MIDAMOR commercial prospects?
   Outcomes that change reimbursement and standard-of-care, typically via a new approved indication and clear guideline uptake.

4. Is the relevant market measured by MIDAMOR brand sales or by amiloride class use?
   For forecasting, amiloride class consumption is a more stable basis; brand share is a second step that depends on channel and payer mix.

5. What is the most realistic time horizon for meaningful growth in MIDAMOR?
   Without label expansion or proprietary formulation adoption, meaningful growth is unlikely; timelines typically require regulatory and payer behavior change, which is multi-year.

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References (APA)

[1] National Library of Medicine. (n.d.). Amiloride (drug information). ClinicalTrials.gov. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drug approval reports and labeling resources. https://www.fda.gov/