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Pregabalin Release Tablets
Pregabalin binds to the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system, reducing the release of excitatory neurotransmitters.
Pregabalin binds to the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system, reducing the release of excitatory neurotransmitters. Used for Neuropathic pain (diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury pain), Partial-onset seizures (adjunctive therapy), Generalized anxiety disorder.
At a glance
| Generic name | Pregabalin Release Tablets |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | Gabapentinoid; anticonvulsant; anxiolytic |
| Target | Voltage-gated calcium channel alpha-2-delta-1 subunit |
| Modality | Small molecule |
| Therapeutic area | Neurology; Pain Management; Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Pregabalin is an anticonvulsant and anxiolytic agent that modulates calcium channel activity by binding to the alpha-2-delta-1 subunit, thereby decreasing calcium influx and subsequent neurotransmitter release. This mechanism reduces neuronal hyperexcitability and is effective in treating neuropathic pain, epilepsy, and anxiety disorders. The extended-release tablet formulation aims to provide sustained therapeutic levels with improved dosing convenience.
Approved indications
- Neuropathic pain (diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury pain)
- Partial-onset seizures (adjunctive therapy)
- Generalized anxiety disorder
- Fibromyalgia
Common side effects
- Dizziness
- Somnolence
- Dry mouth
- Edema
- Blurred vision
- Weight gain
- Headache
Key clinical trials
- Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject (PHASE1)
- A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy (PHASE3)
- A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain (PHASE4)
- Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome (PHASE3)
- Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia (PHASE2, PHASE3)
- Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets
- A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation (PHASE1)
- Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pregabalin Release Tablets CI brief — competitive landscape report
- Pregabalin Release Tablets updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI