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
Portal Hypertension	15
Liver Cirrhosis	13
Healthy	13
Infantile Hemangioma	9

Condition MeSH

Condition MeSH for Propranolol Hydrochloride
Intervention	Trials
Stress Disorders, Post-Traumatic	30
Stress Disorders, Traumatic	26
Hemangioma	21
Liver Cirrhosis	20

Clinical Trial Locations for Propranolol Hydrochloride

Trials by Country

Trials by Country for Propranolol Hydrochloride
Location	Trials
United States	216
China	30
Canada	26
France	17
Egypt	14

Trials by US State

Trials by US State for Propranolol Hydrochloride
Location	Trials
New York	25
Texas	18
California	16
Pennsylvania	14
Massachusetts	12

Clinical Trial Progress for Propranolol Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Propranolol Hydrochloride
Clinical Trial Phase	Trials
Phase 4	65
Phase 3	34
Phase 2/Phase 3	23

Clinical Trial Status

Clinical Trial Status for Propranolol Hydrochloride
Clinical Trial Phase	Trials
Completed	136
Unknown status	51
Recruiting	47

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
National Institute on Drug Abuse (NIDA)	7

Sponsor Type

Sponsor Type for Propranolol Hydrochloride
Sponsor	Trials
Other	414
NIH	52
Industry	52

Propranolol Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Propranolol Hydrochloride, a non-selective beta-blocker, has been a cornerstone in the treatment of various cardiovascular and other conditions for decades. This article delves into the current clinical trials, market analysis, and future projections for this versatile drug.

Mechanism and Therapeutic Uses

Propranolol Hydrochloride works by blocking the β-adrenoceptors, thereby reducing the sympathetic nervous system's action on the heart and blood vessels. This mechanism leads to a decrease in heart rate, blood pressure, and oxygen demand, making it effective for treating conditions such as hypertension, angina pectoris, atrial fibrillation, and certain cardiac dysrhythmias[1][4].

Clinical Trials Update

Ongoing and Recent Trials

Several clinical trials are currently underway or have recently concluded, exploring new indications and optimizing existing treatments.

• Cerebral Hemorrhage-Associated Pneumonia: A trial (NCT05419193) is investigating the use of Propranolol in preventing pneumonia associated with cerebral hemorrhage, a significant complication of stroke. This study aims to improve patient outcomes by mitigating one of the most critical predictors of poor prognosis in stroke patients[5].
• Multiple Myeloma: A Phase 2 trial (NCT05561751) is examining the combination of Propranolol with G-CSF and Burixafor in patients with multiple myeloma. Preliminary results indicate positive outcomes, suggesting potential new avenues for cancer treatment[1].
• Bleeding Esophageal Varices: A Phase 4 trial has shown positive results for the use of Propranolol in combination with endoscopic variceal ligation (EVL) for managing bleeding esophageal varices in patients with cirrhosis[1].

Pharmacokinetic Studies

Recent pharmacokinetic studies, such as those outlined in the Clinical Evaluation Report for Hemangiol (Propranolol HCl), have compared the bioavailability of oral solution and tablet formulations. These studies have confirmed that the plasma concentration profiles of Propranolol are similar for both formulations, ensuring consistent therapeutic effects[4].

Market Analysis

Market Size and Growth

The global market for Propranolol Hydrochloride has experienced significant growth in recent years. As of 2023, the market was valued at approximately US$ 23 million and is projected to reach US$ 30 million by 2030, with a Compound Annual Growth Rate (CAGR) of 4.0% during the forecast period from 2024 to 2030[3].

Market Segmentation

The market is segmented based on type (purity levels of ≥99% and ≥99.5%), application (tablets, capsules, oral liquids), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2][3].

Key Players

Major players in the Propranolol Hydrochloride market include Pierre Fabre, HIKMA, Mylan, Teva, and ZYDUS PHARMS. These companies are driving the market through their extensive product portfolios and strategic market positioning[3].

Market Projections

Forecasted Growth

The Propranolol Hydrochloride market is expected to continue its upward trend, driven by increasing demand for cardiovascular treatments and the exploration of new therapeutic applications. The forecasted growth is supported by positive market dynamics, including rising healthcare expenditures and an aging population[2][3].

Regional Outlook

The Asia-Pacific region is anticipated to be a significant growth driver due to its large population, increasing healthcare infrastructure, and growing awareness of cardiovascular diseases. Other regions, such as North America and Europe, will also contribute substantially to the market growth due to their established healthcare systems and high demand for beta-blockers[2].

Applications and Indications

Traditional Uses

Propranolol Hydrochloride is widely used for treating hypertension, angina pectoris, certain cardiac dysrhythmias, and preventing migraine. It is also effective in managing essential tremor and anxiety-related tachycardia[1][4].

Emerging Indications

Recent studies and clinical trials are exploring its potential in treating conditions such as proliferating infantile hemangioma, cerebral hemorrhage-associated pneumonia, and even certain types of cancer, as mentioned in the multiple myeloma trial[1][4][5].

Side Effects and Monitoring

While Propranolol Hydrochloride is effective, it can cause side effects such as fatigue, dizziness, and depression. Therefore, it is crucial to use this medication under the guidance of a healthcare provider and to monitor patients closely for any adverse effects[1].

Key Takeaways

• Clinical Trials: Ongoing trials are exploring new indications, including cerebral hemorrhage-associated pneumonia and multiple myeloma.
• Market Growth: The global market for Propranolol Hydrochloride is projected to grow from US$ 23 million in 2023 to US$ 30 million by 2030.
• Market Segmentation: The market is segmented by type, application, and geographical regions.
• Key Players: Major pharmaceutical companies such as Pierre Fabre, HIKMA, Mylan, Teva, and ZYDUS PHARMS are driving the market.
• Applications: Traditional uses include hypertension, angina pectoris, and cardiac dysrhythmias, with emerging indications in infantile hemangioma and cancer.

FAQs

What is the primary mechanism of action of Propranolol Hydrochloride?

Propranolol Hydrochloride works by blocking the β-adrenoceptors, reducing the sympathetic nervous system's action on the heart and blood vessels.

What are the traditional therapeutic uses of Propranolol Hydrochloride?

It is traditionally used to treat hypertension, angina pectoris, certain cardiac dysrhythmias, and to prevent migraine.

What are some emerging indications for Propranolol Hydrochloride?

Emerging indications include treating proliferating infantile hemangioma, cerebral hemorrhage-associated pneumonia, and certain types of cancer.

Who are the major players in the Propranolol Hydrochloride market?

Major players include Pierre Fabre, HIKMA, Mylan, Teva, and ZYDUS PHARMS.

What is the projected market size for Propranolol Hydrochloride by 2030?

The market is forecasted to reach US$ 30 million by 2030, with a CAGR of 4.0% during the forecast period from 2024 to 2030.

Sources

1. Propranolol Hydrochloride - Drug Targets, Indications, Patents. Synapse.
2. Global Propranolol HCL Market Size, Scope And Forecast Report. Market Research Intellect.
3. Propranolol Hydrochloride - Market Size - Valuates Reports. Valuates Reports.
4. Extract from the Clinical Evaluation Report for Hemangiol Propranolol HCl. Therapeutic Goods Administration.
5. PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE). CenterWatch.