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.

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
National Institutes of Health (NIH)	8
National Institute of Mental Health (NIMH)	8
Taipei Veterans General Hospital, Taiwan	8

Sponsor Type

Sponsor Type for PROPRANOLOL HYDROCHLORIDE
Sponsor	Trials
Other	470
NIH	55
Industry	53

Last updated: July 26, 2026

Propranolol Hydrochloride Clinical Trials Update, Market Analysis, and 2026–2036 Projection

Propranolol hydrochloride is a widely used, off-patent small molecule indicated for cardiovascular and a set of off-label uses, with ongoing clinical research focused on new formulations, pediatric control strategies, dosing paradigms, and disease-area expansion. Market growth over the next decade is expected to be modest in unit terms and driven primarily by (1) incremental formulation uptake, (2) pediatric and specialty-channel demand, and (3) geographic adoption in markets where propranolol remains a cost-effective first-line option. Competitive pressure is structurally high because the active ingredient is generic.

What is the current clinical trial landscape for propranolol hydrochloride?

Answer: Propranolol trials in the near term cluster around optimized dosing regimens, pediatric use logistics, and reformulation (including sustained or targeted delivery), with smaller programs exploring novel indications or mechanistic expansions.

What trial types dominate (and what endpoints are most common)?

Across active and recent studies, propranolol research most often tests:

• Safety and tolerability in pediatrics (vital sign monitoring, bradycardia/hypotension risk controls, adherence to dose-escalation rules).
• Efficacy endpoints by disease-area, typically:
  • Symptom control and functional measures in neurologic or psychiatric settings.
  • Lesion or growth suppression metrics in dermatology/vascular indications where propranolol is standard of care in many settings.
  • Hemodynamic endpoints in cardiovascular-adjacent protocols.
• Pharmacokinetic and exposure matching where reformulated products are involved (sustained release, orally disintegrating concepts, or pediatric-friendly presentations).

Which study populations show the most activity?

• Pediatrics: high volume due to the long-standing use of propranolol in infantile hemangioma practice patterns and ongoing attempts to standardize care pathways.
• Patients requiring titration-heavy management: trials often include structured monitoring protocols rather than purely efficacy comparisons.
• Subgroups with adherence barriers: reformulation and dosing schedule optimization trials tend to target this segment.

What are the most likely “next readouts” categories?

Clinical readouts likely to move the market in a measurable way are:

• Pediatric efficacy/safety protocol studies that support guideline adoption or standard-of-care reinforcement.
• Reformulation outcomes that improve adherence (dose frequency reduction) without changing pharmacology.
• Evidence generating payer- and formulary-friendly positioning through comparative tolerability or simplified monitoring.

Which indications drive propranolol demand and what is the outlook by segment?

Answer: Demand is anchored in established cardiovascular use and reinforced by pediatric and specialty uses. Growth is expected to come from specialty-channel uptake and formulation differentiation, not from new blockbuster indications.

Cardiovascular baseline demand

Propranolol hydrochloride is a nonselective beta-blocker used in:

• Hypertension and other cardiovascular indications where beta-blockade remains relevant.
• Off-label and practice-guided uses for tremor and performance anxiety syndromes in many countries. Even where propranolol competes with more beta-1 selective agents, it retains market access due to cost and clinician familiarity.

Dermatology and pediatric specialty demand

Propranolol demand remains structurally supported by pediatric vascular lesion care patterns, with trials and clinical practice focused on:

• Standardization of initiation (dose start and titration).
• Monitoring pathways that reduce hospitalization burden.
• Consolidation around dosing algorithms that balance lesion regression with bradycardia risk.

Neurology and other off-label demand

Evidence and clinical use in neurologic indications (such as migraine prevention in select contexts, tremor, and performance-related symptoms) tends to be practice- and guideline-driven. Trial activity is periodic rather than continuous across all jurisdictions.

How big is the global propranolol hydrochloride market and what is the 2026–2036 projection?

Answer: Propranolol is an entrenched, generic small-molecule market. Total addressable value is large, but growth is typically limited by commoditization, pricing pressure, and mature penetration. Near-term CAGR is expected to be low-to-mid single digits in value, with unit growth outpacing value growth.

Market model used for projection (practical structure)

A projection for a mature generic beta-blocker typically decomposes into:

1. Base demand growth: population growth plus continued guideline use.
2. Formulation mix shift: sustained-release and improved pediatric-friendly formats increase unit uptake.
3. Pricing and reimbursement: net declines often offset mix gains.
4. Geographic uptake: higher relative growth in emerging markets where access and formulary standardization lag.

2016–2026 reality check (generic commodity behavior)

• Pricing erosion dominates value growth.
• Market share shifts occur mainly by manufacturing reliability, supply contracts, and localized payer preferences.
• Product launches that change dosing convenience can produce mix lift even in an off-patent landscape.

2026–2036 projection (high-level)

Given the commoditized active ingredient:

• Value CAGR: low-to-mid single digits globally, with higher variance by region.
• Unit CAGR: mid single digits where pediatric and specialty care pathways expand.
• Most growth-contributing categories:
  • Pediatric and specialty presentations that reduce caregiver burden.
  • Markets with expanding regulated pediatric formularies.

What is the competitive landscape for propranolol hydrochloride?

Answer: Competition is dominated by generic manufacturers and value-chain players controlling API procurement, formulation capacity, and regulatory approvals. Differentiation is usually formulation-level or packaging-level rather than patent-driven.

Who are the typical competitive players?

The market includes:

• Large global generic groups with robust US and EU manufacturing footprint.
• Regional manufacturers in emerging markets supplying lower price points.
• Specialty generics that target pediatric formulations and stable supply.

What competitive levers actually matter?

• Regulatory approvals and bioequivalence: faster entry after approvals and fewer supply interruptions.
• Pediatric presentation availability: dosing accuracy, palatability, and caregivers’ administration practicality.
• Supply chain and manufacturing scale: propranolol remains sensitive to batch yield constraints and excipient supply continuity.

What patents protect propranolol hydrochloride and how does this affect exclusivity timelines?

Answer: The active ingredient propranolol hydrochloride is off-patent in most major jurisdictions. The practical IP perimeter is usually limited to:

• Formulation patents for specific dosage forms or release profiles.
• Method-of-use patents (where they exist) tied to particular disease-area claims.
• Manufacturing process improvements for certain NDA/ANDA reference products or follow-on approvals.

How do generic entry risks behave in an off-patent small molecule?

• Generics generally face fewer barriers once the reference is off-patent.
• The remaining risk is mainly tied to product-specific formulation or device-related patents, not to the core API.

What does this mean for exclusivity?

• Expected exclusivity is minimal at the molecule level.
• Any exclusivity in the market typically belongs to specific branded or follow-on formulations, not to propranolol hydrochloride as a whole.

What is the Orange Book status of propranolol hydrochloride?

Answer: The active ingredient is widely available with many ANDA listings and no meaningful, molecule-wide exclusivity. Orange Book entries are expected to be extensive and dominated by generics, with any remaining exclusivity tied to specific products or supplemental approvals.

How to interpret the Orange Book for commoditized APIs

• Look for specific NDCs with listed patents to map which formulations could have remaining IP hooks.
• For market access planning, the critical detail is the patent expiration date by product, not the API label.

What generic entry risks exist for propranolol hydrochloride formulations?

Answer: Generic entry risk is tied to whether a target product has still-active formulation or method-of-use patents. For the core drug, risk is generally low.

Where do barriers still occur in practice?

• Sustained-release or pediatric-friendly formulations that have follow-on patent protection.
• Specific dosage forms requiring unique manufacturing or release mechanics.
• Indication-specific claims if a product is marketed under a protected method-of-use.

How does this affect licensing strategy?

• Licensing tends to focus on:
  • Product-specific IP for new dosage forms.
  • Rights to manufacturing know-how for reliable scale-up.
  • Exclusivity by way of regulatory differentiation rather than patent exclusivity.

How does propranolol compare with other beta-blockers on market outlook?

Answer: Propranolol competes with beta-1 selective agents and other nonselectives. Its market stability comes from cost and clinician familiarity, but it typically grows slower in markets that prefer more cardioselective profiles.

Competitive positioning drivers

• Cost advantage in tender or formulary settings.
• Clinical familiarity and established protocols.
• Pediatric and specialty-channel reliability when pediatric formulations are available.

What FDA regulatory pathways affect propranolol hydrochloride market entry and updates?

Answer: Most entries are via ANDAs leveraging bioequivalence to reference products. Clinical trial updates in this category often focus on formulation refinement and pediatric suitability rather than first-of-kind approval pathways.

What do regulatory updates usually change?

• Switches in manufacturing sites or process validation updates.
• Changes to excipients and dissolution targets for modified-release products.
• Pediatric dosage form compliance steps.

What recent clinical evidence is most likely to change prescribing behavior?

Answer: The most likely practice-changing evidence is not new mechanism science but operational and clinical management evidence:

• Standardized pediatric titration protocols.
• Monitoring pathway simplifications that reduce hospitalization or intensive monitoring needs.
• Reformulations that improve adherence and reduce dosing frequency.

What market scenarios are most plausible for 2026–2036?

Answer: Three scenarios map to how pricing and specialty mix evolve.

Scenario 1: Low growth, persistent price erosion

• Stable unit growth, weak value growth due to continued generic discounting.
• Mix shift helps but is outweighed by price declines.

Scenario 2: Moderate value growth via formulation mix

• Sustained-release and pediatric-friendly uptake lifts revenue per treated patient.
• More stable pricing in regulated pediatric programs.

Scenario 3: Higher growth in emerging markets

• Access expansion drives faster unit uptake.
• Value remains modest due to lower local price ceilings.

Key Takeaways

• Propranolol hydrochloride remains a mature, generic small molecule with clinical trial activity focused on dosing optimization, pediatric monitoring, and formulation improvements.
• Market value growth is expected to remain constrained by price erosion; unit growth is the primary lever.
• Competitive differentiation is formulation- and supply-chain based, with remaining IP typically product-specific rather than molecule-wide.
• 2026–2036 projection: low-to-mid single digit value CAGR globally with higher variance by region and pediatric/specialty uptake patterns.

FAQs

1. Do propranolol hydrochloride clinical trials focus more on pediatric safety or new indications?
   Pediatric safety and dosing protocols dominate, with occasional niche studies in specialty indications.

2. What formulation changes most often improve adherence for propranolol?
   Sustained-release and pediatric-friendly presentations that reduce dosing frequency and improve administration consistency.

3. How do generic manufacturers compete in a propranolol hydrochloride market?
   By securing regulatory approval speed, stable supply, and packaging/formulation reliability rather than by novel mechanism IP.

4. What is the main risk to launching a new propranolol dosage form?
   The risk is whether product-specific formulation or method-of-use patents are still listed and enforceable for the target NDC.

5. Which regional markets typically show faster propranolol volume growth?
   Markets with expanding pediatric programs and broader guideline penetration tend to outpace mature markets, though value remains price-sensitive.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. ClinicalTrials.gov. propranolol hydrochloride (and propranolol) studies. https://clinicaltrials.gov/