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Paroxetine CR
Paroxetine CR selectively inhibits the reuptake of serotonin at the neuronal synapse, increasing serotonin availability in the brain.
Paroxetine CR selectively inhibits the reuptake of serotonin at the neuronal synapse, increasing serotonin availability in the brain. Used for Major depressive disorder, Generalized anxiety disorder, Panic disorder.
At a glance
| Generic name | Paroxetine CR |
|---|---|
| Also known as | Paxil CR, Paxil |
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Drug class | Selective serotonin reuptake inhibitor (SSRI) |
| Target | Serotonin transporter (SERT) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | FDA-approved |
Mechanism of action
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) that blocks the serotonin transporter protein, preventing the reabsorption of serotonin from the synaptic cleft back into presynaptic neurons. This increases serotonin concentration in the synapse, enhancing neurotransmission and improving mood regulation. The CR (controlled-release) formulation provides sustained drug delivery over 24 hours.
Approved indications
- Major depressive disorder
- Generalized anxiety disorder
- Panic disorder
- Obsessive-compulsive disorder
- Post-traumatic stress disorder
- Social anxiety disorder
Common side effects
- Nausea
- Headache
- Insomnia
- Somnolence
- Sexual dysfunction
- Sweating
- Tremor
- Diarrhea
Key clinical trials
- Fasting Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg (PHASE1)
- Food Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg (PHASE1)
- A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder (PHASE3)
- Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy (PHASE4)
- Efficacy of Hydroxyzine for Patients With Panic Disorder (PHASE4)
- Efficacy and Safety of Oxybutynin Versus Paroxetine in Aromatase Inhibitor-induced Vasomotor Symptoms (PHASE3)
- Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression (NA)
- Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder (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:
- Paroxetine CR CI brief — competitive landscape report
- Paroxetine CR updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI