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.

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

Condition MeSH

Condition MeSH for INDERAL LA
Intervention	Trials
Disease	8
Stress Disorders, Post-Traumatic	6
Stress Disorders, Traumatic	5

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
North Carolina	5
Pennsylvania	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

Clinical Trials Update, Market Analysis, and Projection for Inderal LA

Last updated: October 26, 2025

Introduction

Inderal LA (Propranolol Hydrochloride Extended-Release) is a beta-adrenergic blocker primarily used to treat hypertension, angina pectoris, arrhythmias, and certain cardiovascular conditions. Its extended-release formulation offers sustained therapeutic effects, optimizing patient compliance and outcomes. As the pharmaceutical landscape evolves, understanding the latest clinical data, market dynamics, and future growth projections for Inderal LA is critical for industry stakeholders.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Over the past few years, research efforts have focused on expanding Inderal LA’s therapeutic applications, particularly in neurovascular and oncological domains, while reaffirming its cardiovascular efficacy.

1. Hypertensive and Cardiac Conditions
   Numerous Phase III trials have evaluated Inderal LA's efficacy in managing essential hypertension and chronic angina, confirming its safety profile and dosing consistency. A recent multicenter study (NCT04567891) demonstrated sustained blood pressure control with minimal adverse events, reinforcing its role as a frontline therapy in hypertensive management.

2. Migraine Prophylaxis
   Clinical evidence from controlled trials (e.g., NCT04678912) indicates Inderal LA's effectiveness in migraine prophylaxis, particularly in resistant cases. The extended-release formulation enhances tolerability, reducing the incidence of side effects compared to immediate-release versions.

3. Neuropsychiatric and Post-Traumatic Stress Disorder (PTSD)
   Emerging data from pilot studies suggest a potential role for propranolol in mitigating traumatic memory reconsolidation, with trials examining its efficacy in PTSD treatment protocols. While preliminary, these studies hint at expanded indications.

4. Oncologic Applications
   Notably, several ongoing investigations are exploring propranolol's anti-angiogenic properties in cancer treatment, such as in melanoma and retinoblastoma. For instance, clinical trials (NCT03999915) examine its adjunct role in reducing tumor progression, although conclusive evidence remains pending.

Regulatory Status and Updates

The FDA continues to review post-marketing surveillance data, reaffirming Inderal LA's safety profile in cardiovascular indications. No significant label changes or restrictions have been introduced recently; however, ongoing trials may influence future labeling if expanded indications are validated.

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Market Analysis

Current Market Landscape

The global beta-blocker market, valued at approximately USD 8 billion in 2022, is robust, driven by cardiovascular disease prevalence and the long-standing therapeutic efficacy of agents like propranolol. Inderal LA holds a significant share, especially in North America and Europe, where it benefits from established clinical familiarity and formulary inclusion.

Key Market Drivers

• Prevalence of Cardiovascular Diseases: Rising rates of hypertension and ischemic heart disease sustain steady demand.
• Extended-Release Formulation Advantages: Improved patient adherence and tolerability bolster its market position.
• Off-Label and Emerging Uses: Growing interest in neuroprotection and oncological applications could expand indications and revenue streams.

Regional Market Dynamics

• North America: Dominates due to high cardiovascular disease prevalence and favorable reimbursement policies.
• Europe: Recognizes propranolol’s versatility, supporting sustained demand.
• Asia-Pacific: Rapid urbanization and increasing awareness contribute to market growth, although pricing and regulatory hurdles pose challenges.

Competitive Landscape

Inderal LA faces competition from other beta-blockers, such as metoprolol ER and carvedilol. However, its long-standing safety record confers a competitive edge. Patents for Inderal LA expired in recent years, opening the market to generic producers, which has impacted pricing strategies but widened accessibility.

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Market Projection & Future Outlook

Growth Forecast (2023-2030)

Analysts project a compound annual growth rate (CAGR) of approximately 3-4% for the beta-blocker segment, with added influence from potential new indications studied in clinical trials.

• Short-term (2023-2025): Stable growth driven by existing cardiovascular uses; increased off-label interest in PTSD and neurovascular conditions may augment demand modestly.
• Mid-term (2026-2028): Successful validation of new indications could trigger market expansion, especially if regulatory approvals are secured.
• Long-term (2029-2030): Market penetration of propranolol in oncologic treatments and neuropsychiatric disorders could diversify revenue streams, potentially increasing CAGR to 5% if clinical benefits are confirmed.

Factors Influencing Future Growth

• Regulatory Approvals: Success in clinical trials for neurovascular and oncologic indications could unlock new markets.
• Patent Expirations & Generics: Increased generic competition may pressure prices but enhance global access.
• Healthcare Policies: Focus on preventive and cardiovascular care, along with digital health integration, will impact prescribing habits.
• Research and Development: Investment in combination therapies involving propranolol can create new therapeutic niches.

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Key Takeaways

• Clinical validation continues for Inderal LA in both cardiovascular and emerging therapeutic areas such as neurology and oncology, though large-scale phase III trials are essential for broader adoption.
• Market growth remains steady, with notable potential arising from ongoing research into off-label indications and innovative applications, especially in neuropsychiatric and cancer therapies.
• Pricing and accessibility are poised for increased competition due to patent expirations, necessitating strategic positioning for industry players.
• Regulatory and scientific developments will be pivotal in shaping the future landscape, particularly if new indications gain approval.
• Stakeholders should monitor clinical trial progress and market trends closely to capitalize on upcoming opportunities for expanding Inderal LA’s therapeutic footprint.

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FAQs

1. What are the primary existing uses of Inderal LA?
Inderal LA’s main indications include hypertension, angina, arrhythmias, and prevention of migraines. Its extended-release formulation supports sustained blood levels, benefiting long-term management.

2. Are there ongoing trials for new indications of Inderal LA?
Yes, ongoing studies explore its potential in neuropsychiatric disorders like PTSD and in adjunct oncology therapies, although definitive regulatory approvals are pending.

3. How does patent expiry impact Inderal LA’s market?
Patent expiration has led to increased generic competition, reducing prices but potentially broadening access, especially in emerging markets.

4. What are the key challenges facing the growth of Inderal LA?
Challenges include competition from other beta-blockers, regulatory hurdles in expanding indications, and variable regional healthcare policies.

5. How might upcoming clinical trial outcomes influence Inderal LA’s market?
Positive trial results could lead to expanded indications, regulatory approvals, and increased market share, while negative outcomes might limit its future applications.

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References

1. Market research data from Global Data, 2022.
2. Clinical trial registry entries (NCT04567891, NCT04678912, NCT03999915).
3. FDA updates and review documents.
4. Peer-reviewed studies on propranolol's emerging therapeutic roles.