Skip to main content

paroxetine

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

paroxetine: sourced relationships with 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 company relationship 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 evidence2 indications · 1 study sponsors
Dated Pipeline Records (2)
CompanyDated record stage
LANNETT CO INC (LCI)
Reported 2016-06-10 · Current development: unknownSource
Approved
Teva Pharmaceutical Industries Limited (TEVA)
Reported 2007-06-29 · Current development: unknownSource
Approved
Clinical Trial Registry Records (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

NCT07070232Registry updated 2026-10-09·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 2030-0377 sites · Australia, Belgium, China, Germany…BioNTech SE

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

NCT06049797Registry updated 2026-06-05
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

NCT03511118Registry updated 2026-02-11·N/A
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
Approval(TEVA)FDA ↗
ANDA077082OralTablet

Frequently asked questions

Which companies have sourced relationships with paroxetine?

paroxetine has dated SEC/FDA relationship records for 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.