Duloxetine 30 MG: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Duloxetine 30 MG appears in the FDA drug-label database. Marketed as DULOXETINE HYDROCHLORIDE.
- Boxed warning
- The FDA label for Duloxetine 30 MG carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Duloxetine delayed-release capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults (1) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1) Diabetic peripheral neuropathic pain (DPNP) in adults (1) Fibromyalgia (FM) in adults Chronic musculoskeletal pain in adults (1)
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Dissolution Specification — Lupin Pharmaceuticals Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2017-11-21 |
| CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit — Breckenridge Pharmaceutical, Inc. | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-07-15 |
| CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Breckenridge Pharmaceutical, Inc | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2024-12-06 |
| Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle — Breckenridge Pharmaceutical, Inc | Class III (FDA: unlikely to cause harm) | Terminated | 2015-10-21 |
| CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit — Breckenridge Pharmaceutical, Inc. | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-11-24 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Depression | 2 |
| Asthma | 1 |
| Depression in Old Age | 1 |
| Fragility Fracture | 1 |
| Refractory Chronic Cough | 1 |
Recruiting trials involving Duloxetine 30 MG
- Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough
- Identifying and Treating Depression in the Orthopaedic Trauma Population
- Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures
Common questions
Is Duloxetine 30 MG FDA-approved?
Yes, marketed as DULOXETINE HYDROCHLORIDE. Its FDA label carries a boxed warning.
How many recruiting trials involve Duloxetine 30 MG?
3 recruiting trials across 5 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.