INNOPRAN XL (propranolol hydrochloride)
Innopran XL is used to lower blood pressure in patients with hypertension. By controlling high blood pressure, the medication helps reduce the likelihood of fatal and nonfatal cardiovascular events, such as strokes and heart attacks. It is typically prescribed as one component of a comprehensive management plan that may include other medications and lifestyle adjustments to reach cardiovascular health goals.
How INNOPRAN XL Works
The exact mechanism of the antihypertensive effect of Innopran XL has not been fully established. Factors thought to contribute include decreased cardiac output, inhibition of renin release by the kidneys, and a reduction in tonic sympathetic nerve outflow from the brain's vasomotor centers. Although total peripheral resistance may increase initially, it typically readjusts to or below pretreatment levels with chronic use.
Details
- Status
- Prescription
- First Approved
- 2003-03-12
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
INNOPRAN XL Approval History
What INNOPRAN XL Treats
3 indicationsINNOPRAN XL is approved for 3 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Stroke
- Myocardial Infarction
INNOPRAN XL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in INNOPRAN XL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications INNOPRAN XL treats. First-in-class if their pivotal trials read out positive.
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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.
INNOPRAN XL FDA Label Details
Indications & Usage
FDA Label (PDF)INNOPRAN XL is indicated for the treatment of Hypertension; Stroke; Myocardial Infarction.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.