INDERAL LA (propranolol hydrochloride)
Inderal LA is indicated for the management of hypertension and may be used alone or in combination with other antihypertensive agents; however, it is not indicated for hypertensive emergencies. It is also approved to reduce the frequency of angina attacks and increase exercise tolerance in patients with coronary atherosclerosis. Additionally, the medication is used for the prophylaxis of common migraine headaches, though its efficacy in treating an active migraine attack has not been established. Finally, Inderal LA is indicated to improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
How INDERAL LA Works
Propranolol is a non-selective beta-adrenergic receptor blocking agent. It lacks intrinsic sympathomimetic activity and competes with response-eliciting catecholamines for binding at both beta-1 (primarily cardiac) and beta-2 (primarily bronchial and vascular) receptor sites. By blocking these receptors, it decreases heart rate, myocardial contractility, and cardiac output. In hypertension, the mechanism involves a reduction in cardiac output, inhibition of renin release by the kidneys, and a reduction in tonic sympathetic nerve outflow from vasomotor centers in the brain. Its anti-anginal effects are mediated by decreasing myocardial oxygen demand through the reduction of heart rate and force of contraction.
Details
- Status
- Prescription
- First Approved
- 1983-04-19
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
INDERAL LA Approval History
What INDERAL LA Treats
4 indicationsINDERAL LA is approved for 4 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Angina Pectoris
- Migraine
- Hypertrophic Subaortic Stenosis
INDERAL LA 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 INDERAL LA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications INDERAL LA treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
INDERAL LA FDA Label Details
Indications & Usage
FDA Label (PDF)INDERAL LA is indicated for the treatment of Hypertension; Angina Pectoris; Migraine; Hypertrophic Subaortic Stenosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.