CLINICAL TRIALS PROFILE FOR INDERAL LA

All Clinical Trials for Inderal La

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00060866 ↗	Propranolol to Treat Fainting Due to Sympathoadrenal Imbalance	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 4	2003-05-01	This study will examine the effectiveness of the drug propranolol in preventing fainting in patients with sympathoadrenal imbalance (SAI). SAI is a particular pattern of nervous system and chemical responses in which the blood vessels in skeletal muscles do not remain constricted appropriately during standing for a long time. This can lower blood pressure and cause fainting. Propranolol Inderal (registered trademark) is a Food and Drug Administration-approved drug that belongs to a class of drugs called beta-blockers. These drugs slow the heart rate and maintain blood pressure in certain situations. Patients 18 years of age and older with SAI may be eligible for this study. Screening includes a tilt table test, described below, to determine if the patient has a particular chemical pattern in the blood. Patients enrolled in the study take propranolol pills in increasing doses during the first week of the study to determine the proper dose for the individual. Then, the drug is stopped until the experimental phase of the study begins. In this phase, patients are randomly assigned to take either propranolol or placebo (look-alike pill with no active ingredient) for 4 days. On the fourth day, the patient undergoes a tilt table test to determine whether the treatment affects the patient's ability to tolerate tilt. For this test, the patient lies on a padded table with a motorized tilt mechanism that can move the patient from a flat position to an upright position in about 10 seconds. The patient remains upright for up to 45 minutes while the following measurements are taken: - Arterial blood pressure monitoring and arterial blood sampling. A catheter (thin, plastic tube) is inserted into an artery in the elbow crease area of the arm or the wrist. This catheter allows continuous blood pressure monitoring and sampling of arterial (oxygenated) blood during the tilt test. - Venous blood sampling and measurement of epinephrine and norepinephrine release. A catheter is inserted into a vein in each arm, one to collect venous (deoxygenated) blood samples, and the other to inject radioactive epinephrine (adrenaline) and norepinephrine (noradrenaline). These radioactive drugs, or ,tracers, allow measurement of the rate of release of the body's own norepinephrine and epinephrine into the bloodstream. - Physiologic measurements. Blood pressure, heart rate, and EKG are measured continuously during the tilt test session, and blood flows and skin electrical conduction are measured intermittently. Blood flow is measured using sensors applied to the skin and a blood pressure cuff around the limb. For skin blood flow measurements, a laser beam scans the skin surface. The skin electrical conduction test measures how well the skin conducts electricity. This is measured through sensors placed on the fingers or other sites. The effects of the test drug are allowed to wear off for 1 week, after which the entire tilt test procedure is repeated. Patients who were given propranolol for the first test session take placebo for the repeat session, and those who were given placebo take propranolol.
NCT00093860 ↗	Propranolol to Treat Fainting in Children With Sympathoadrenal Imbalance	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-10-01	This study will examine the effectiveness of the drug propranolol in preventing fainting in patients with sympathoadrenal imbalance (SAI). SAI is a particular pattern of nervous system and chemical responses in which the blood vessels in skeletal muscles do not remain constricted appropriately during standing for a long time. This can lower blood pressure and cause fainting. Propranolol (Inderal® (Registered Trademark)) is a Food and Drug Administration-approved drug that belongs to a class of drugs called beta-blockers. These drugs slow the heart rate and maintain blood pressure in certain situations. Children between 10 and 17 years of age with frequent fainting or near-fainting due to SAI may be eligible for this study. Children must experience severe dizzy episodes at least once every 2 months or fainting episodes at least once every 4 months. The condition must be severe enough to affect the child's quality of life or to have forced the child to alter his or her life routines to accommodate to the illness. Screening includes a tilt table test, described below, to determine if the child has a particular chemical pattern in the blood. Children enrolled in the study take propranolol pills in increasing doses during the first week of the study to determine the proper dose for the individual. Then, the drug is stopped until the experimental phase of the study begins. In this phase, children are randomly assigned to take either propranolol or placebo (a look-alike pill with no active ingredient) for a maximum of 3 days. On the fourth day, the child undergoes a tilt table test to determine whether the treatment affects his or her ability to tolerate tilt. For this test, the child lies on a padded table with a motorized tilt mechanism that can move the child from a flat position to an upright position in about 10 seconds. The child remains upright for up to 40 minutes while the following measurements are taken: - Blood sampling: Blood is drawn through a catheter (thin plastic tube) placed in an arm vein. This allows repeated sampling without repeated needle sticks. Samples are collected before starting the tilt test, about every 4 minutes during the test, immediately when a drop in blood pressure is detected or symptoms develop, and after 10 minutes of recovery lying flat. A maximum of 12 samples are collected for each tilt test. - Physiologic measurements: Blood pressure, heart rate, and electrocardiogram (EKG) are measured continuously during the tilt test session, and blood flows and skin electrical conduction are measured intermittently. Blood flow is measured using sensors applied to the skin and a blood pressure cuff around the limb. For skin blood flow measurements, a laser beam scans the skin surface. The skin electrical conduction test measures how well the skin conducts electricity. This is measured through sensors placed on the tips of two fingers. Respiration and breathing rate are monitored by an elastic cloth band around the chest. - Self-report questionnaires: Patients or their parents complete a questionnaire about the child's symptoms before and during treatment. The effects of the test drug are allowed to wear off for up to 1 week, after which the entire tilt test procedure is repeated. Patients who were given propranolol for the first test session take placebo for the repeat session, and those who were given placebo take propranolol.
NCT00158262 ↗	Effect of Propranolol on Preventing Posttraumatic Stress Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	2004-09-01	This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of posttraumatic stress disorder in acutely traumatized individuals.
NCT00158262 ↗	Effect of Propranolol on Preventing Posttraumatic Stress Disorder	Completed	Massachusetts General Hospital	Phase 4	2004-09-01	This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of posttraumatic stress disorder in acutely traumatized individuals.
NCT00174902 ↗	The Effect of Beta-Blockers and Aspirin on Hemostasis and Endothelial Function After Acute Mental Stress	Unknown status	Swiss National Science Foundation	Phase 1/Phase 2	2003-10-01	This randomized double-blinded controlled trial uses a factorial design to investigate whether application of beta-blockers (inderal 80 mg) or aspirin (100 mg) or a combination thereof has an effect on the activation of the hemostatic system, the platelets and the endothelium in response to acute mental stress. Specifically we test the hypothesis that inderal attenuates the activation of the hemostatic system as compared to placebo. The second hypothesis is that aspirin attenuates the activation of platelets as compared to placebo. Subjects will be randomly allocated to either of the four following study arms: placebo - inderal - aspirin - inderal plus aspirin. Subjects will receive the study medication for five days prior to the mental stress. The acute mental stress consists of a public speaking session of 10 min duration immediately followed by a mental arithmetic test of 5 min duration. Blood will be collected prior to the stress, immediately thereafter, at 45 min at at 1 hour and 45 min.

Clinical Trial Conditions for Inderal La

Condition Name

Condition Name for Inderal La
Intervention	Trials
Post-Traumatic Stress Disorder	4
Healthy	4
Posttraumatic Stress Disorder	3
Postural Tachycardia Syndrome	2

Condition MeSH

Condition MeSH for Inderal La
Intervention	Trials
Disease	8
Stress Disorders, Post-Traumatic	6
Stress Disorders, Traumatic	5
Tachycardia	4

Clinical Trial Locations for Inderal La

Trials by Country

Trials by Country for Inderal La
Location	Trials
United States	73
Italy	4
Canada	3
Egypt	3
Switzerland	2

Trials by US State

Trials by US State for Inderal La
Location	Trials
New York	8
California	7
Massachusetts	6
Pennsylvania	5
Ohio	5

Clinical Trial Progress for Inderal La

Clinical Trial Phase

Clinical Trial Phase for Inderal La
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	3
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Inderal La
Clinical Trial Phase	Trials
Completed	30
Recruiting	14
Terminated	11

Clinical Trial Sponsors for Inderal La

Sponsor Name

Sponsor Name for Inderal La
Sponsor	Trials
Massachusetts General Hospital	4
National Institute of Neurological Disorders and Stroke (NINDS)	3
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for Inderal La
Sponsor	Trials
Other	86
Industry	16
NIH	13

Inderal La Market Analysis and Financial Projection

Last updated: April 27, 2026

INDERAL LA (propranolol hydrochloride, extended-release): Clinical-trial update, market analysis, and projections

What is INDERAL LA and what is its regulatory footprint?

INDERAL LA is an extended-release formulation of propranolol hydrochloride. The product name “INDERAL LA” is used for the extended-release version of propranolol, marketed for cardiovascular and related indications depending on labeling. As propranolol is an established, off-patent active ingredient in most major markets, the competitive and commercial dynamics hinge on formulation exclusivity (if any), authorized generics, payer coverage, and substitutions rather than new molecular patent estates.

Regulatory note for market modeling: For established generics, the relevant “trial update” is rarely about breakthrough efficacy signals and more often about label maintenance, formulation bioequivalence, and post-marketing safety. INDERAL LA’s public clinical-trial signal is therefore typically sparse versus new chemical entities.

What do clinical trials show right now for INDERAL LA?

No active, large-scale, brand-driving late-stage trials are identifiable in standard public registries that would change clinical practice for INDERAL LA specifically. Public trial activity for propranolol in general exists, but it is usually tied to:

• New indications (off-label studies, academic trials),
• Other propranolol formulations (immediate-release or different controlled-release products),
• Combination regimens and mechanistic studies.

Actionable implication: For investment and R&D planning around INDERAL LA, the “clinical-trial update” is not a major near-term catalyst. The product’s trajectory is driven more by generic substitution and formulary placement than by new clinical evidence.

What is the current market structure?

INDERAL LA sits in a category with these characteristics:

• Active ingredient maturity: Propranolol is widely available as generics in extended-release and immediate-release forms.
• Low differentiation: Therapeutic class expectations constrain pricing power.
• Substitution pressure: Pharmacy-level substitution to cheaper AB-rated alternatives limits branded revenue.
• Payer behavior: Coverage is typically determined by cost, copays, and step edits within beta-blockers.

Market conclusion for valuation: The brand’s economics behave like a declining or plateauing branded segment unless a payer or specialty channel treats the extended-release formulation as preferred.

Where does INDERAL LA typically compete?

Within beta-blockers, INDERAL LA competes against:

• Immediate-release propranolol (lower cost, more dosing flexibility),
• Other extended-release beta-blockers (metoprolol ER, carvedilol ER, atenolol, nadolol depending on country/formulary),
• Alternative propranolol controlled-release products that are generically available.

What is the revenue outlook under generic substitution dynamics?

A branded extended-release beta-blocker with an off-patent molecule typically follows a pattern:

1. Early generics entry: brand share declines as payers align to lowest net cost.
2. Stabilization: brand share reaches a floor where physicians or patients prefer a specific formulation and where formulary design includes a named drug.
3. Ongoing drift: intermittent competitive entries and wholesale pricing pressure gradually push total category spending down on a per-unit basis.

Projection logic for INDERAL LA (high level):

• Without molecule-level exclusivity, brand volume growth is unlikely.
• Total addressable demand for propranolol ER is mainly replacement demand tied to ongoing patients rather than net new starts at scale.
• Market growth in beta-blockers usually comes from broader cardiovascular prevalence and prescribing patterns, but brand capture usually erodes under generic penetration.

Quantitative market projection framework (what to model for INDERAL LA)

Because INDERAL LA is not a late-stage, patent-protected specialty product, the most decision-useful projection is a scenario model driven by share and net price rather than by clinical uptake curves.

Use these core model variables:

• Branded net price index (relative to generic propranolol ER)
• Brand Rx share (or share of prescriptions among propranolol ER options)
• Persistency (beta-blocker continuation at 6, 12, 24 months)
• Rebate and plan design shifts (formulary placement changes)
• Competitive entries (new generic SKUs, authorized generics, AB-rated changes)

Market projection scenarios

Below is a template for projecting annual performance. It is structured for operational use: plug in current brand share and net price to compute revenues.

Scenario (2026-2030)	Net Price (annual drift vs base year)	Brand Rx Share Drift	Revenue Direction
Base case	2% to 4% annual erosion	1% to 2% absolute decline or stabilization to floor	Flat to modest decline
Downside (faster substitution)	4% to 7% annual erosion	Additional 1% to 3% absolute decline	Moderate decline
Upside (formulary stickiness)	1% to 3% annual erosion	Share stabilizes sooner due to payer preference for ER	Plateau or slight growth

Operational KPI targets:

• Maintain brand share floor by defending formulary status and reducing net price volatility.
• Protect conversion for “switch back” from immediate-release to ER where clinically requested.
• Monitor copay card policies and patient out-of-pocket sensitivity (beta-blockers can be very sensitive to cost at pharmacy).

What are the main demand drivers for propranolol ER products (INDERAL LA class)?

1. Cardiovascular indications where beta-blockers remain standard of care.
2. Chronic disease management and long persistency relative to oncology.
3. Patient-specific preference for extended-release adherence benefits.
4. Physician habits and practice-level switching resistance (small, but affects share floors).

What are the main downside risks?

1. Further formulary tightening toward the lowest-cost AB-rated generic.
2. Wholesale price competition that compresses branded net price.
3. Channel shifts: more claims processed under narrow networks.
4. Lack of clinical differentiation that can justify premium pricing for ER.

Does INDERAL LA have a near-term catalyst in clinical development?

No near-term catalyst is implied by the current public trial landscape for INDERAL LA as a named branded ER product. In practice, catalysts for off-patent branded generics come from:

• new formulation advantages,
• authorized generic arrangements changing brand share,
• label expansions (rare for propranolol),
• or major payer policy shifts.

Competitive landscape implications for investors and R&D teams

For investment: INDERAL LA behaves like a steady-state brand under heavy generic pressure. The upside is limited to share defense, rebates, and channel-specific preference rather than clinical innovation.

For R&D: If the goal is to pursue propranolol ER market growth, R&D value is more likely in:

• improved release profiles (bioavailability consistency, food effect reduction),
• safety convenience (dose titration design),
• or differentiated fixed-dose regimens (if pursued with intellectual property and clinical substantiation).

What do you project for INDERAL LA market share and volume through 2030?

Given standard generic penetration patterns for propranolol-based products, a reasonable high-level expectation is:

• Share erosion continues, but at a slowing rate once the brand reaches a formulary and prescriber “floor.”
• Volume declines modestly relative to overall category shrinkage, while the larger pressure is net price erosion rather than disappearance.

A decision-useful planning approach is to forecast:

• Total propranolol ER category prescriptions as roughly stable to mildly declining (depending on country-level substitution and physician preferences),
• INDERAL LA brand share trending toward a floor,
• Net price trending down toward generic parity, with periodic spikes when competitive intensity changes.

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Key Takeaways

• INDERAL LA is an extended-release propranolol brand in a mature, off-patent market where generic substitution dominates economics.
• Public clinical trial activity does not present a branded INDERAL LA late-stage catalyst that would materially change adoption patterns.
• Near-term performance depends on formulary placement, rebate/net price, and brand share defense rather than new clinical efficacy evidence.
• Projections through 2030 should be modeled primarily as net price erosion plus share drift to a floor, with scenario ranges based on substitution speed.

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FAQs

1. Is INDERAL LA’s growth driven by new clinical evidence?
   No. The current public clinical landscape for propranolol does not indicate a branded INDERAL LA late-stage program that would drive adoption.

2. What is the primary commercial risk to INDERAL LA?
   Generic substitution that compresses net price and reduces brand prescription share.

3. What variables matter most in forecasting INDERAL LA revenue?
   Brand Rx share trend, net price erosion vs authorized generics, and payer/formulary placement changes.

4. Does extended-release format create durable demand?
   It can support a share floor due to adherence and prescriber preference, but it usually does not stop net price erosion in an off-patent molecule.

5. Where can the best opportunity exist for INDERAL LA-like products?
   In channel-specific contracting and formulation differentiation where it can be clinically or operationally justified.

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References

[1] FDA. Drug Trials Snapshots: Propranolol (search results for propranolol/INDERAL-related labeling and submissions). U.S. Food and Drug Administration.
[2] ClinicalTrials.gov. Propranolol studies (search results for propranolol and extended-release formulations). U.S. National Library of Medicine.
[3] EMA. Public Assessment Reports and product information for propranolol-containing medicines (search results). European Medicines Agency.