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paroxetine

Generic: PAROXETINE MESYLATE·Brand: BRISDELLE, Brisdelle, PAROXETINE, PAROXETINE HYDROCHLORIDE, PAROXETINE MESYLATE, PAXIL, PAXIL CR, PEXEVA, Paxil, Pexeva

paroxetine: developed by 2 companies · 3 clinical trials tracked · 2 FDA decisions.

paroxetine evidence translation

What we can confirm

2 FDA records · 3 tracked trials

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about paroxetine, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 2 study sponsors

Related indications

Hot Flashes
Development Pipeline (2)
CompanyPhase
LANNETT CO INC (LCI)Approved
Teva Pharmaceutical Industries Limited (TEVA)Approved
Clinical Trials (3)

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors

NCT07070232·Phase 1/Phase 2·BNTX
Recruiting

Primary endpoint: Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), treatment emergent serious adverse events (TESAEs), and treatment related serious adverse events (TRSAEs)

InterventionalRandomizedopen1,438 targetStarted 2025-08Completion 2030-0350 sites · Australia, Belgium, Germany, Italy…BioNTech SE

A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms

NCT06049797
Completed

Primary endpoint: Mean change from baseline to week 12 in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall VMS domain score

Observational999 enrolledStarted 2023-11Completion 2026-0548 sites · United StatesAstellas Pharma Global Development, Inc.

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

NCT03511118·N/A·INSM
Recruiting

Primary endpoint: M/P ratio

Observational1,600 targetStarted 2018-10Completion 2027-0722 sites · Canada, United StatesDuke University
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE Paroxetine is indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Premenstrual Dysphoric Disorder (PMDD)(LCI)FDA ↗
ANDA204744UNKNOWNOralTablet, Extended Release
Approval1 INDICATIONS AND USAGE Paroxetine tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Obsessive compulsive disorder (OCD) Panic disorder (PD) Social anxiety disorder (SAD) Generalized anxiety disorder (GAD) Posttraumatic stress disorder (PTSD) Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder(TEVA)FDA ↗
ANDA077082OralTablet

Frequently asked questions

Who is developing paroxetine?

paroxetine is being developed by LANNETT CO INC, Teva Pharmaceutical Industries Limited.

How many clinical trials involve paroxetine?

BioSniper tracks 3 clinical trials involving paroxetine.

What is paroxetine's latest FDA decision?

The most recent tracked FDA decision for paroxetine is Approval for 1 INDICATIONS AND USAGE Paroxetine is indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Premenstrual Dysphoric Disorder (PMDD), dated June 10, 2016.