Pregabalin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Pregabalin appears in the FDA drug-label database. Marketed as PREGABALIN.
FDA-approved use
Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1 ) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older ( 1) Fibromyalgia ( 1) Neuropathic pain associated with spinal cord injury (1 )
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
| FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. — Pfizer Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2016-01-11 |
| Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg. — Rising Pharma Holding, Inc. | Class III (FDA: unlikely to cause harm) | Ongoing | 2024-05-16 |
| FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. — Pfizer Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2016-01-11 |
| Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient. — SUN PHARMACEUTICAL INDUSTRIES INC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-10-22 |
Phase breakdown
Conditions being studied
Recruiting trials involving Pregabalin
- Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA
- The Efficacy and Safety of Pregabalin Combined With Desvenlafaxine in Patients With Fibromyalgia
- The Efficacy and Safety of Pregabalin Combined With Dexmedetomidine in Patients With Fibromyalgia
- The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia
- The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia
- The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia
- The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia
Common questions
Is Pregabalin FDA-approved?
Yes, marketed as PREGABALIN.
How many recruiting trials involve Pregabalin?
7 recruiting trials across 10 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.