HEMANGEOL (propranolol hydrochloride)
Hemangeol is an oral solution used for infants who have proliferating hemangiomas. It helps patients with these vascular growths when they require systemic therapy. This beta-adrenergic blocker is specifically used to manage the progression of these infantile birthmarks.
How HEMANGEOL Works
While Hemangeol is a beta-adrenergic blocker, the exact way it works to affect infantile hemangiomas is not well understood.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-03-14
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- SOLUTION
HEMANGEOL Approval History
What HEMANGEOL Treats
1 indicationsHEMANGEOL is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Infantile Hemangioma
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06445166 | 202408004 | Ph 2 | recruiting | Propranolol for the Treatment of Kaposi Sarcoma in Adults |
| NCT04848519 | STUDY00002186 NCI-2021-00437, WINSHIP5200-20 | Ph 2 | active not recruiting | Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma |
| NCT05997732 STARS | Pro00126600 | Ph 4 | recruiting | Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences |
| NCT05651594 | I 2734222 NCI-2022-09209, I 2734222 | Ph 2 | recruiting | Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma |
| NCT04713657 | 23-12026881 R01HL155597 | Ph 1 | recruiting | Beta-blocker Administration for Cardiomyocyte Division |
| NCT06833320 | AAAV5303 | Ph 1, Ph 2 | suspended | Propranolol Treatment for Postoperative Chylothorax |
| NCT05085782 | 2022-4092 | Ph 2 | completed | Reconsolidation Therapy With Propranolol as a Treatment for Chronic Pain |
| NCT05419193 PRO-CHASE | KY-2022-05-07-001 | Ph 2, Ph 3 | completed | PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE) |
| NCT03384836 | I 53217 NCI-2017-02210, I 53217 | Ph 1, Ph 2 | suspended | Propranolol Hydrochloride and Pembrolizumab in Treating Patients With Stage IIIC-IV Melanoma That Cannot Be Removed by Surgery |
| NCT03633747 | SAHZJU-Y2018-059 | Ph 1, Ph 2 | terminated | Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma |
| NCT03152786 results posted | IRB00043227 NCI-2017-00788, CCCWFU 85716 | Ph 2 | terminated | Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery |
| NCT05979818 BRIO | XYEYY20230705 | Ph 1 | recruiting | Propranolol Hydrochloride in Combination With Sintilimab and Platinum-based Chemotherapy for Treatment of Advanced Non-small Cell Lung Cancer |
| NCT04299438 PROPEL results posted | 834760 | Ph 3 | terminated | Propranolol Rescue of Prolonged Labor |
| NCT04467086 PROACTIVE | 776228483 | Ph 3 | completed | Propranolol as an Anxiolytic to Reduce the Use of Sedatives From Critically-ill Adults Receiving Mechanical Ventilation |
| NCT01988831 | HUG-MEL-BB | Ph 2 | suspended | Efficacy of Propranolol Treatment to Prevent Melanoma Progression |
| NCT03254186 | IRB00096912 | Ph 2, Ph 3 | withdrawn | Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HEMANGEOL FDA Label Details
Indications & Usage
FDA Label (PDF)HEMANGEOL is indicated for the treatment of Infantile Hemangioma.
Pro Intelligence Preview
Deep insights for HEMANGEOL
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 2 active patents
Trial Analysis
- • 17 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment