Propranolol: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Propranolol appears in the FDA drug-label database. Marketed as Propranolol Hydrochloride.
- Boxed warning
- The FDA label for Propranolol carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Hypertension Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Hypertrophic Subaortic Stenosis Propranolol Hydrochloride Extended-Release Capsules, USP, improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection. — Fresenius Kabi USA, LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2014-08-13 |
| CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. — CARDINAL HEALTHCARE | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-01-26 |
Phase breakdown
Conditions being studied
Recruiting trials involving Propranolol
- Comparative Efficacy of Flunarizine and Propanolol in Pediatric Migraine
- Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
- Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC.
- Naltrexone and Propranolol Combined With Immunotherapy
- Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer
Common questions
Is Propranolol FDA-approved?
Yes, marketed as Propranolol Hydrochloride. Its FDA label carries a boxed warning.
How many recruiting trials involve Propranolol?
5 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.