CLINICAL TRIALS PROFILE FOR HEMANGEOL

All Clinical Trials for HEMANGEOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01222091 ↗	Study on the Effect of a Beta Blocker on Increased Sensitivity to Pain in Humans Caused by Opioids	Completed	Stanford University	Phase 2	2009-02-01	This research study explores whether a beta-blocker (propranolol) can prevent a person from becoming more sensitive to pain after administration of an opioid (remifentanil). Beta blockers inhibit the sympathetic (fight or flight) response and are often used to treat angina and high blood pressure. In a previous study in human volunteers, the investigators demonstrated an increased sensitivity to pain after a 60-minute infusion of the opioid remifentanil. The goal of this study is to identify a possible inhibitor of this phenomenon.
NCT02595996 ↗	Propranolol Dose Escalation in Lymphedema in Patients	Terminated	Columbia University	Phase 2	2017-06-07	This is a study to investigate the safety and efficacy of propranolol in the treatment of patients with primary lymphedema. The primary goal is to assess patient tolerability of increasing doses of propranolol. The secondary goal is to assess lymphedema symptoms and signs in response to propranolol treatment.
NCT02871349 ↗	Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response	Completed	United States Department of Defense	Early Phase 1	2016-08-01	The purpose of this study is to find out how the brain of people with autism is affected by Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA approved for the treatment of heart conditions such as blood pressure This research is being done because there are currently no drug treatment options for language impairments and social difficulties often experienced by people with autism.
NCT02871349 ↗	Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response	Completed	University of Missouri-Columbia	Early Phase 1	2016-08-01	The purpose of this study is to find out how the brain of people with autism is affected by Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA approved for the treatment of heart conditions such as blood pressure This research is being done because there are currently no drug treatment options for language impairments and social difficulties often experienced by people with autism.
NCT04741698 ↗	Propranolol for Protracted Labor	Recruiting	Christiana Care Health Services	Phase 1	2021-07-27	Induction of labor is one of the most common procedures performed on labor and delivery. In the United States, more than 20 percent of pregnant women undergo an induction of labor [1]. There is data from small, randomized studies that demonstrates the effectiveness of propranolol, a non-selective beta-blocker, for labor augmentation. This literature suggests a decrease in the amount of time to delivery and a possible reduction in cesarean section rates when propranolol is used in conjunction with oxytocin for induction of labor compared to oxytocin alone [2-8]. Alpha- and beta-adrenergic receptors have been identified in the human myometrium. Propranolol has been shown in studies to enhance uterine contractions and may be a useful tool in this population of women. Therefore, the purpose of this study is to assess whether the administration of propranolol at time of labor dystocia reduces time to delivery.

Clinical Trial Conditions for HEMANGEOL

Condition Name

Condition Name for HEMANGEOL
Intervention	Trials
Autism Spectrum Disorder	1
Hyperalgesia	1
Labor Dystocia	1
Labour;Obstructed	1

Condition MeSH

Condition MeSH for HEMANGEOL
Intervention	Trials
Lymphedema	1
Hyperalgesia	1
Dystocia	1
Disease	1

Clinical Trial Locations for HEMANGEOL

Trials by Country

Trials by Country for HEMANGEOL
Location	Trials
United States	4

Trials by US State

Trials by US State for HEMANGEOL
Location	Trials
Delaware	1
Missouri	1
New York	1
California	1

Clinical Trial Progress for HEMANGEOL

Clinical Trial Phase

Clinical Trial Phase for HEMANGEOL
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	1
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for HEMANGEOL
Clinical Trial Phase	Trials
Completed	2
Recruiting	1
Terminated	1

Clinical Trial Sponsors for HEMANGEOL

Sponsor Name

Sponsor Name for HEMANGEOL
Sponsor	Trials
Stanford University	1
Columbia University	1
United States Department of Defense	1

Sponsor Type

Sponsor Type for HEMANGEOL
Sponsor	Trials
Other	4
U.S. Fed	1

HEMANGEOL (propranolol) Clinical Trials Update, Market Analysis, and Projection

Last updated: May 6, 2026

What is HEMANGEOL and what is its current clinical/label status?

HEMANGEOL is oral propranolol indicated for treatment of infantile hemangioma requiring systemic treatment, including proliferating infantile hemangioma. The product is positioned as a standardized propranolol therapy for infants and toddlers, with dosing and safety monitoring designed around pediatric use.

Regulatory positioning (key point for market sizing):

• The commercial claim scope is tied to infantile hemangioma that requires systemic therapy, not all hemangiomas.
• Pediatric propranolol use is constrained by patient selection and monitoring (hypoglycemia, bradycardia, hypotension, bronchospasm risk), which shapes addressable population and persistence.

What does the clinical trial landscape look like now?

Public clinical programs for propranolol in infantile hemangioma have largely matured since pivotal efficacy work. Current value for investors and competitors is less about new “drug class” proof and more about:

• Label maintenance and real-world dosing optimization
• Formulation or dosing regimen refinements
• Long-term outcomes and safety characterization
• Use in subgroups (anatomic sites, severity tiers, treatment timing)

Given the constraint that a complete, accurate “current trials” update requires a verified, date-stamped registry pull (e.g., ClinicalTrials.gov/EudraCT with status and results fields), no trial-level timeline can be produced here without risking fabrication.

What is the current commercial footprint by geography and channel?

HEMANGEOL is marketed by Pierre Fabre. Commercial performance is typically reported through company releases and regional distributors; however, producing a rigorous market analysis and projection requires a verified set of:

• patient-treated assumptions
• pricing and reimbursement net of rebates in major markets
• penetration vs competing off-label propranolol
• channel mix (hospital vs specialty pharmacy where applicable)

Without a cited dataset (sales, TRx, net price by region, and reimbursement coverage), a defensible market model cannot be completed.

How is the competitive landscape structured?

The competitive frame for HEMANGEOL is driven by three forces:

1. Competing propranolol access

   • Off-label oral propranolol is widely used in pediatric settings where clinicians manage dosing and monitoring.
   • HEMANGEOL’s differentiation is primarily standardized dosing and pediatric-focused formulation and label-driven protocolization rather than new mechanism of action.

2. Other systemic infantile hemangioma therapies

   • Corticosteroids (where still used) face declining preference in many geographies due to side-effect profiles and propranolol efficacy/safety tradeoffs.
   • Other investigational agents exist in the class of hemangioma therapeutics, but market impact depends on approvals that are geographically specific.

3. Institutional protocols and guideline adherence

   • Where protocols specify propranolol for qualifying proliferating lesions, HEMANGEOL captures share through convenience, dosing confidence, and payer acceptance of labeled therapy.

What is the addressable patient pool and what drives conversion to treated patients?

HEMANGEOL’s addressable market depends on converting diagnosed infantile hemangioma into systemic-treatment candidates. Key conversion drivers:

• severity and risk phenotype (functional impairment, ulceration, high-risk locations)
• age at treatment initiation (treatment windows affect eligibility and recurrence management)
• clinician adoption of propranolol vs alternatives
• payer coverage of branded propranolol vs compounding/generic/off-label access

A reliable projection requires epidemiology inputs (incidence and proportion requiring systemic therapy) and payer/uptake data, which must be sourced to avoid overstating magnitude.

Market projection: what can be stated from sourced, verifiable facts?

A quantified revenue and unit projection for HEMANGEOL requires at minimum:

• baseline sales (last available year) and geographic breakdown
• patent/market exclusivity calendar by major market
• expected penetration vs generic/off-label erosion
• competitive and reimbursement dynamics
• trial pipeline catalysts or headwinds

No cited, date-stamped baseline or model inputs were provided in the prompt, and producing such numbers without source-backed inputs would violate accuracy requirements.

Key business implications (deal-relevant, without fabricated numbers)

Even without a quantified model, the decision-relevant implications for HEMANGEOL are concrete:

• Branded pediatric beta-blocker share is sensitive to off-label and generic access, because the active ingredient is the same as off-label propranolol and institutional confidence can shift prescribing behavior when monitoring infrastructure is available.
• Persistence is driven by protocol adherence and treatment duration. Infantile hemangioma treatment courses are time-bound; share is influenced by how consistently clinicians treat qualifying cases rather than switching to alternative endpoints.
• Payer coverage is often the binding constraint. Branded positioning depends on whether payers accept labeled propranolol for qualifying systemic cases while patients and clinicians can access lower-cost off-label propranolol.

Key Takeaways

• HEMANGEOL is a branded, labeled oral propranolol therapy for infantile hemangioma requiring systemic treatment, with market dynamics anchored in pediatric eligibility, monitoring, and payer coverage rather than novel mechanism differentiation.
• The “clinical trials update” and any “market projection” with numbers cannot be produced accurately without a sourced, date-stamped trials registry pull and baseline market data.
• The most material competitive lever is off-label/generic propranolol access, which can pressure uptake even when clinical protocols recommend systemic beta-blockade.

FAQs

1) What condition is HEMANGEOL approved to treat?
HEMANGEOL is approved for infantile hemangioma requiring systemic treatment, including proliferating infantile hemangioma that needs systemic therapy.

2) Is HEMANGEOL differentiated by mechanism?
No. HEMANGEOL’s differentiation is primarily labeled, standardized pediatric propranolol dosing and use-case fit, not mechanism of action.

3) What is the biggest risk to HEMANGEOL revenue growth?
Uptake pressure from off-label propranolol and lower-cost access where monitoring protocols enable clinician prescribing.

4) What most affects the addressable patient pool?
The share of infants with infantile hemangioma who qualify for systemic-treatment thresholds based on lesion risk features and clinical eligibility.

5) What drives treatment adoption by hospitals and prescribers?
Institutional protocols and ease of implementing a branded, label-aligned regimen that supports pediatric safety monitoring.

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References

[1] HEMANGEOL prescribing information. Pierre Fabre.
[2] ClinicalTrials.gov. Search results for propranolol infantile hemangioma and HEMANGEOL (status and dates vary by study).
[3] EMA product information: HEMANGEOL (if applicable in EMEA filings). European Medicines Agency.