CLINICAL TRIALS PROFILE FOR PROPRANOLOL HYDROCHLORIDE

505(b)(2) Clinical Trials for propranolol hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01512173 ↗	Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo	Completed	Pierre Fabre Dermatology	Phase 2	2012-01-01	There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile. Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use. The objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma.
New Combination	NCT02641314 ↗	Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma	Recruiting	University of Cologne	Phase 2	2016-12-22	Neuroblastoma is the second most frequent cause for death from cancer in childhood. Already one year after diagnosis of recurrence from high risk neuroblastoma, 75% of the patients experience further progression. Metronomic therapy is targeting not only the tumor cell, but also the tumor supplying vasculature and the interactions between Tumor and immune cells. The toxicity is expected to be low due to the low (but continuous) dosing of drugs. The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected.
New Combination	NCT02897986 ↗	Study of a Propranolol (HEMANGIOL®) and Oral Metronomic Vinorelbine (NAVELBINE®) Combination for Children and Teenagers With Refractory/Relapsing Solid Tumors	Unknown status	Assistance Publique Hopitaux De Marseille	Phase 1	2017-01-01	Cancer remains the first cause of death due to disease in children and adolescents despite important progress and 70% of the survivors present sequelae. It is therefore mandatory to generate new and preferably less toxic treatment strategies relying on new anticancer agents, and/or new combinations or schedules of administered compounds. Metronomic chemotherapy (MC) consists in administrating low doses of anticancer agents on a daily/weekly basis. MC has been showed to be a safe and effective way to administer chemotherapy to obtain anti-cancer effects through anti-angiogenic and pro-imune effects. Drug repositioning consist in using non-anticancer drug for which anti-cancer properties have been unveiled. Propranolol is a non selective beta-blocker initially used to treat hypertension but recently its anticancer properties have been discovered. The place of Betablockers as anticancer agents is supported by both preclinical and epidemiologic data. The investigators have showed that the use of betablockers could sensitize breast cancer, angiosarcoma and neuroblastoma to chemotherapy in vitro and in vivo at least in part via an anti-angiogenic mechanism. There are currently 12 clinical trials evaluating prospectively their potential in adults with cancer but none in children so far. The Objective is to determine the Maximal Tolerated Dose (MTD) of a combination of oral metronomic vinorelbine and daily oral propranolol. This study is a phase I trial with a "rolling six" design and a dose escalation with thrice weekly oral vinorelbine only plus addition of daily oral propranolol after completion of the first cycle. PK analysis of vinorelbine and propranolol will be performed. Once the recommended dose of the combination established 4 extension cohorts of 9 patients will be added Potential biomarkers (such as beta-adrenergic receptors on the tumours, B-tubulin isotypes in the tumour) will also be evaluated. This will provide a well tolerated, all oral combination for patients with refractory/relapsing tumours. This combination could also be then proposed as a maintenance for instance in patients with rhabdomyosarcoma or neuroblastoma.

All Clinical Trials for propranolol hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000197 ↗	Propranolol for Treatment of Cocaine Addiction - 2	Completed	University of Pennsylvania	Phase 2	1987-01-01	The purpose of this study is to evaluate the safety and efficacy of propanolol in the early treatment of cocaine dependence.
NCT00000197 ↗	Propranolol for Treatment of Cocaine Addiction - 2	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1987-01-01	The purpose of this study is to evaluate the safety and efficacy of propanolol in the early treatment of cocaine dependence.
NCT00000492 ↗	Beta-Blocker Heart Attack Trial (BHAT)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1977-09-01	To determine whether the regular administration of the beta-blocker drug propranolol to people who had had at least one documented myocardial infarction would result in a significant reduction of mortality from all causes over the follow-up period. Eligible volunteer patients were recruited to participate in a double-blind clinical trial within 21 days after the onset of the acute event. One-half of the patients were randomly assigned to a beta-blocking drug (propranolol) and one-half to a placebo. The trial also evaluated the effect of propranolol on incidences of coronary heart disease mortality, sudden cardiac death, and nonfatal myocardial infarction plus coronary heart disease mortality in persons with documented previous myocardial infarction.
NCT00000493 ↗	Multicenter Investigation of Limitation of Infarct Size (MILIS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1977-09-01	To assess the ability of two separate therapeutic interventions, propranolol and hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary objective was to assess the influence of these therapies upon ventricular function and morbidity following myocardial infarction.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00016666 ↗	Clinical Trial of Propranolol for Seasonal Affective Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 2	2001-05-21	The purpose of this study is to determine what dose of a new timed-release tablet of the drug propranolol will reduce secretion of the hormone melatonin in healthy volunteers. This study will also determine whether suppressing melatonin will improve depressive symptoms in people with seasonal affective disorder (SAD). SAD (sometimes referred to as winter depression) is a condition in which people experience depression as a result of seasonal variations in light. Human brains have a circadian pacemaker that regulates many body functions. As the seasons change and light duration varies, the circadian pacemaker regulates seasonal behavior by transmitting a signal of day length to the pineal gland, which secretes the hormone melatonin. Melatonin secretion increases in the winter as the duration of light decreases. Evidence suggests that the melatonin signal of seasonal change is present in people with SAD but not in healthy volunteers; thus there is a possibility that seasonal changes which influence the duration of melatonin secretion control the course of illness in individuals with SAD. This study will determine whether propranolol can shorten the duration of melatonin secretion and mimic the effect of summer days to improve symptoms of depression in people with SAD. Healthy volunteers will be admitted to the hospital for about 2 days. The volunteers will receive either propranolol or placebo (an inactive pill) before going to bed and upon awakening. Blood samples will be collected at various times throughout the study. Participants with SAD will be interviewed periodically on an outpatient basis to determine the onset of depression in the fall or winter. Two weeks after depressive symptoms arise, participants will begin treatment with either propranolol or placebo. At the beginning of the treatment, participants will be hospitalized for about 2 days and will have blood collected at various times. During the hospital stay, participants will continue treatment with either propranolol or placebo in the morning and at night; all participants will receive propranolol at some point during the study. Participants will be interviewed weekly for 4 weeks. Premenopausal women with or without SAD will keep a record of their menstrual cycles and will use a urine test kit to identify the time of ovulation during the month before and after admission to the hospital.

Clinical Trial Conditions for propranolol hydrochloride

Condition Name

Condition Name for propranolol hydrochloride
Intervention	Trials
Liver Cirrhosis	16
Portal Hypertension	16
Healthy	13
Migraine	12

Condition MeSH

Condition MeSH for propranolol hydrochloride
Intervention	Trials
Stress Disorders, Post-Traumatic	30
Stress Disorders, Traumatic	26
Liver Cirrhosis	23
Migraine Disorders	23

Clinical Trial Locations for propranolol hydrochloride

Trials by Country

Trials by Country for propranolol hydrochloride
Location	Trials
United States	229
China	42
Canada	26
Egypt	20
France	19

Trials by US State

Trials by US State for propranolol hydrochloride
Location	Trials
New York	28
Texas	19
California	17
Pennsylvania	14
North Carolina	12

Clinical Trial Progress for propranolol hydrochloride

Clinical Trial Phase

Clinical Trial Phase for propranolol hydrochloride
Clinical Trial Phase	Trials
PHASE4	11
PHASE3	4
PHASE2	8

Clinical Trial Status

Clinical Trial Status for propranolol hydrochloride
Clinical Trial Phase	Trials
Completed	142
RECRUITING	69
Unknown status	51

Clinical Trial Sponsors for propranolol hydrochloride

Sponsor Name

Sponsor Name for propranolol hydrochloride
Sponsor	Trials
Taipei Veterans General Hospital, Taiwan	8
National Institutes of Health (NIH)	8
National Institute of Mental Health (NIMH)	8

Sponsor Type

Sponsor Type for propranolol hydrochloride
Sponsor	Trials
Other	470
NIH	55
Industry	53

Last updated: April 27, 2026

Propranolol Hydrochloride: Clinical Trials Update, Market Analysis, and Projection

What does the clinical trial landscape look like for propranolol hydrochloride?

Propranolol hydrochloride is an established, off-patent small-molecule beta blocker with broad, legacy clinical use in cardiology and select off-label indications. Across major registries, trial activity persists, but it is dominated by (1) updated clinical evidence generation, (2) investigator-initiated or protocol-driven studies, and (3) reformulation or dose/route exploration rather than first-in-class development.

Key patterns that define the current trial landscape:

• Cardiovascular endpoints (heart rate, arrhythmia metrics, blood pressure effects, post-acute outcomes) remain the most frequent therapeutic theme in interventional studies.
• Oncology-supportive and symptom-modifying use cases (such as performance anxiety, tremor, and other symptomatic indications) show ongoing but fragmented trial patterns.
• Peri-procedural and peri-illness beta blockade studies continue in smaller populations where endpoint-driven designs can be implemented without new chemistry.

What is not consistent with proprietary development: propranolol itself is widely generic, so trial designs rarely signal proprietary mechanism differentiation. That reduces the visibility of “pipeline-like” differentiation and shifts the market thesis toward label expansion, guideline uptake, and manufacturing competition.

Which trial categories are most likely to influence near-term market behavior?

The trials that most influence near-term commercialization are those tied to:

• Regulatory label expansion (new or refined indications, pediatric subsets, dosing regimens)
• Guideline or payer adoption for existing labeled indications (typically via outcome endpoints)
• Evidence consolidation in defined subpopulations (for example, faster titration strategies or alternative routes)

In practice, propranolol’s near-term market impact tends to come from clinical guideline updates and formulary positioning rather than from breakthrough late-stage evidence.

---

Market analysis

How big is the propranolol hydrochloride opportunity today?

The global market for propranolol-based products is best framed as a generic beta blocker category with multiple manufacturers and price compression. Direct “propranolol hydrochloride only” sizing is not consistently reported as a standalone line item by most market research firms because propranolol often sits inside:

• beta blockers (nonselective)
• generic cardiovascular agents
• antiarrhythmics and antihypertensives market groupings

Operationally, the investable unit for propranolol is the product footprint:

• branded legacy products (where they still exist regionally)
• authorized generics
• non-authorized generics
• liquid and tablet formulations
• pediatric-appropriate presentations

Commercial reality: market value is driven by unit volume and pricing power, not by patent duration. That means the “market opportunity” is often a manufacturing and access story, not an R&D story.

What are the demand drivers that keep propranolol relevant?

Demand persists because propranolol has:

• entrenched clinical use in cardiovascular care pathways
• durable off-label demand in symptom control
• broad prescriber familiarity
• consistent oral dosing availability and cost accessibility through generics

Where are structural pressure points in pricing and supply?

Because propranolol is off-patent, pricing is pressured by:

• generic entry and parallel supply
• tender-based contracting in many markets
• substitution by other low-cost beta blockers depending on payer preferences
• inventory and quality events that can briefly disrupt supply, then normalize

---

Market projection

What is the likely trajectory for the propranolol hydrochloride market (2025-2035)?

A defensible projection structure for propranolol is:

• Base case: modest growth aligned with underlying cardiovascular and symptom-treatment demand, offset by continued price erosion from generic competition
• Downside: further price pressure, formulary substitution toward other nonselective or selective beta blockers, and localized supply constraints
• Upside: measurable label expansion or stronger guideline inclusion in high-volume subpopulations, plus differentiated formulations (for example, pediatric-friendly dosing forms)

Given the category dynamics, most propranolol market outcomes are dominated by:

• volume stability
• pricing normalization after manufacturing shocks
• regional reimbursement and procurement cycles

Net projection logic (directional): expect low-to-mid single-digit CAGR in revenue only if volume growth or minor price stabilization occurs; otherwise revenue can track flatter or slightly down while prescriptions remain steady.

How should investors and R&D teams model value creation?

Value creation in an off-patent beta blocker usually comes from:

• manufacturing scale and cost leadership
• regulatory access speed (filings, approvals, switching)
• formulation differentiation where clinically meaningful (pediatric dosing, stability, palatability, or route options)
• contracting advantages (preferred supplier status, tender wins)

For R&D budgeting, the viable commercial pathway is label-supporting evidence or formulation work with clear switching incentives, not new mechanism claims.

---

Competitive landscape (practical implications)

Who competes for propranolol share?

Competition is characterized by:

• multiple global and regional generic manufacturers
• local tender and pharmacy substitution dynamics
• alternative beta blocker switching when clinically acceptable

In markets where substitution is tight, the “effective competitor set” includes other nonselective beta blockers and select alternatives with better reimbursement.

What does differentiation look like for an off-patent asset?

Differentiation is typically one or more of:

• bioavailability and stability through formulation work
• pediatric dosing convenience
• supply reliability
• packaging aligned with institutional prescribing patterns

---

What matters most for the next 24 months

Which developments are most likely to move the commercial needle?

Focus on:

• guideline updates that explicitly mention propranolol for high-volume conditions
• formulary changes by major payers and hospital systems
• competitive tender outcomes that alter procurement pricing
• any regulatory label or dosing refinement that changes prescribing behavior

---

Key Takeaways

• Propranolol hydrochloride is an off-patent, widely generic beta blocker; trial activity exists but typically supports evidence consolidation and specific subpopulation or formulation questions rather than proprietary differentiation.
• Market performance is driven primarily by unit volume, procurement pricing, and supply stability, not patent-protected innovation.
• Near-term upside is most likely to come from guideline and formulary adoption plus differentiated formulations, not from new mechanism breakthroughs.

---

FAQs

1) Is propranolol still under active clinical development?

Yes. Ongoing studies typically focus on specific clinical contexts, subpopulations, dosing strategies, or formulation-related questions rather than new chemistry.

2) What is the main economic risk for propranolol commercialization?

Ongoing generic price pressure from competing manufacturers and substitution by other beta blockers in tender-driven and formulary-controlled environments.

3) What evidence most impacts prescribing and payer decisions?

Outcome data tied to guideline-relevant pathways and clear subpopulation definitions, plus practical dosing or tolerability findings.

4) How can an off-patent drug grow revenue?

Through manufacturing scale, faster regulatory access, improved formulation convenience (especially for pediatrics), and preferential procurement positioning.

5) What is the most credible market projection framework?

Model volume trends against expected pricing erosion, then layer scenario inputs for guideline/formulary changes and procurement outcomes.

---

References (APA)

[1] ClinicalTrials.gov. (n.d.). Propranolol studies. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drug approvals and labels for propranolol hydrochloride and related beta blockers. https://www.fda.gov/
[3] EMA. (n.d.). European public assessment reports for propranolol-containing products (where applicable). https://www.ema.europa.eu/
[4] World Health Organization. (n.d.). WHO model list and beta blocker background resources. https://www.who.int/
[5] DrugBank. (n.d.). Propranolol: pharmacology and clinical information. https://go.drugbank.com/