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Duloxetine Hydrochloride Enteric Capsules
Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases levels of serotonin and norepinephrine in the central nervous system by blocking their reuptake at the presynaptic membrane.
Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases levels of serotonin and norepinephrine in the central nervous system by blocking their reuptake at the presynaptic membrane. Used for Major depressive disorder, Generalized anxiety disorder, Diabetic peripheral neuropathic pain.
At a glance
| Generic name | Duloxetine Hydrochloride Enteric Capsules |
|---|---|
| Sponsor | Zhejiang Huahai Pharmaceutical Co., Ltd. |
| Drug class | Serotonin-norepinephrine reuptake inhibitor (SNRI) |
| Target | Serotonin transporter (SERT) and norepinephrine transporter (NET) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Pain Management |
| Phase | Phase 3 |
Mechanism of action
By inhibiting the reuptake of both serotonin and norepinephrine, duloxetine increases the concentration of these neurotransmitters in synaptic spaces, enhancing their signaling. This dual mechanism is thought to improve mood regulation and pain perception. The enteric coating formulation delays release until the drug reaches the small intestine, potentially improving tolerability and reducing gastrointestinal side effects.
Approved indications
- Major depressive disorder
- Generalized anxiety disorder
- Diabetic peripheral neuropathic pain
- Fibromyalgia
- Chronic musculoskeletal pain
Common side effects
- Nausea
- Dizziness
- Somnolence
- Dry mouth
- Constipation
- Fatigue
- Headache
- Insomnia
- Sexual dysfunction
Key clinical trials
- A Phase II Study to Evaluate NH102 for Depression (PHASE2)
- Efficacy and Safety Study of Levomilnacipran Hydrochloride Extended-Release Capsules in Major Depressive Disorder (PHASE3)
- A Study of the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression (PHASE2)
- Study of Desvenlafaxine in Treating Major Depressive Disorder. (PHASE3)
- Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression (PHASE2)
- Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Feeding Conditions (PHASE1)
- Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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