Drugs / [S,S]-Reboxetine
last change Jan 2020 re-read 2 minutes ago

[S,S]-Reboxetine

also known as Esreboxetine · PNU-165442g
Developed for
fibromyalgia · attention deficit-hyperactivity disorder · diabetic neuropathy · female stress incontinence · major depressive disorder
Investigated by
Pfizer · Viatris Inc.

Trials 19 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT00800956 Jan → Feb 2009 Pfizer Completed No outcome recorded
Phase 1 NCT00809289 Dec 2008 → Jul 2009 fibromyalgia Pfizer Completed No outcome recorded
Phase 212 trials
Phase 2 NCT00752505 Aug 2008 → Jun 2009 fibromyalgia Pfizer Completed No outcome recorded
Phase 2 NCT00625833 Dec 2007 → Nov 2008 diabetic neuropathy Pfizer Terminated No outcome recorded
Phase 2 NCT00562055 Nov 2007 → ? attention deficit-hyperactivity disorder Pfizer Withdrawn No outcome recorded
Phase 2 NCT00354094 Nov 2006 → Oct 2007 Pfizer Terminated No outcome recorded
Phase 2 NCT00334685 Aug 2006 → Oct 2007 Pfizer Terminated No outcome recorded
Phase 2 NCT00357825 Aug 2006 → Mar 2007 Pfizer Completed No outcome recorded
Phase 2 NCT00348894 Jul 2006 → Oct 2007 Pfizer Terminated No outcome recorded
Phase 2 NCT00353808 Jul 2006 → Oct 2007 Pfizer Terminated No outcome recorded
Phase 2 NCT00288652 Mar 2006 → Feb 2007 Pfizer Completed No outcome recorded
Phase 2 NCT00141128 Dec 2005 → Jun 2006 female stress incontinence Pfizer Completed No outcome recorded
Phase 34 trials
Phase 3 NCT00796601 May 2009 → May 2010 fibromyalgia Pfizer Withdrawn No outcome recorded
Phase 3 NCT00754221 May 2008 → May 2009 fibromyalgia Pfizer Terminated No outcome recorded
Phase 3 NCT00612170 Dec 2007 → May 2009 fibromyalgia Pfizer Completed No outcome recorded
Phase 3 NCT00607256 Oct 2007 → May 2009 fibromyalgia Pfizer Terminated No outcome recorded
Phase not applicable1 trial
NCT00444548 May → Jul 2007 Pfizer Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2020-01-13 Pfizer Axsome Therapeutics Enters into Exclusive License Agreement with Pfizer Inc. for Pfizer’s Reboxetine Clinical and Nonclinical Data and for New Phase 3 Esreboxetine Product Candidate pfizer.com

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 19 sources stand behind the page.

FieldValueCited text
Known as [S,S]-reboxetine “Tablets, 50mg sertraline/2mg \[S,S\]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg \[S,S\]-reboxetine for 4 and one half weeks, followed by 150mg...” NCT00636246
14

“Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care” NCT00348894

NCT00334685

NCT00607256

NCT00625833

NCT00353808

NCT00354094

NCT00357825

NCT00562055

NCT00143442

NCT00754221

NCT00288652

NCT00444548

NCT00348894

NCT00612170

Known as Esreboxetine “17 women with stress urinary incontinence or mixed urinary incontinence received 4 mg esreboxetine or placebo for 7 to 9 days followed by a washout period before crossing over...” PMID 19375093 Apr 2009
4

NCT00796601

NCT00809289

NCT00752505

NCT00800956

Known as PNU-165442g “A Phase 2B Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Postherpetic Neuralgia (PHN).” NCT00354094
4

“A Phase 2 Randomized Double-Blind Placebo-Controlled Crossover Study Assessing The Ability Of Esreboxetine (PNU-165442g) To Improve Cognitive Function In Fibromyalgia Patients.” NCT00752505

“A Multi-center, Long-term, Open-label Extension Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia” NCT00754221

“A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia” NCT00607256

“Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care” NCT00348894

Route Oral “[S,S]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks” NCT00334685