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- | ganaxolone oral (CCD-1042) / Marinus
Review, Journal: A new generation of antidepressants: an update on the pharmaceutical pipeline for novel and rapid-acting therapeutics in mood disorders based on glutamate/GABA neurotransmitter systems. (Pubmed Central) - Aug 3, 2019
Here, we review progress in the development of compounds that act on these systems as well as their purported mechanisms of action. We include glutamate-targeting drugs, such as racemic ketamine, esketamine, lanicemine (AZD6765), traxoprodil (CP-101,606), EVT-101, rislenemdaz (CERC-301/MK-0657), AVP-786, AXS-05, rapastinel (formerly GLYX-13), apimostinel (NRX-1074/AGN-241660), AV-101, NRX-101, basimglurant (RO4917523), decoglurant (RG-1578/RO4995819), tulrampator (CX-1632/S-47445), and riluzole; and GABA-targeting agents, such as brexanolone (SAGE-547), ganaxolone, and SAGE-217.
- | Zulresso (brexanolone) / Sage Therapeutics
Journal: Brexanolone (Zulresso) for Postpartum Depression. (Pubmed Central) - Jul 3, 2019
We include glutamate-targeting drugs, such as racemic ketamine, esketamine, lanicemine (AZD6765), traxoprodil (CP-101,606), EVT-101, rislenemdaz (CERC-301/MK-0657), AVP-786, AXS-05, rapastinel (formerly GLYX-13), apimostinel (NRX-1074/AGN-241660), AV-101, NRX-101, basimglurant (RO4917523), decoglurant (RG-1578/RO4995819), tulrampator (CX-1632/S-47445), and riluzole; and GABA-targeting agents, such as brexanolone (SAGE-547), ganaxolone, and SAGE-217. No abstract available
- ||| Zulresso (brexanolone) / Sage Therapeutics
As seen in @JAMA_current, Brexanolone (Zulresso) for Postpartum Depression: https://t.co/P9owzfYNSh #postpartumdepression #PPD (Twitter) - Jul 2, 2019
- | Zulresso (brexanolone) / Sage Therapeutics
$LGND $SAGE Launches Zulresso CIV for PPD https://t.co/MRYMqYtHJH (Twitter) - Jul 1, 2019
- ||| Zulresso (brexanolone) / Sage Therapeutics
Sage Therapeutics Announces U.S. Drug Enforcement Administration Scheduling of ZULRESSO™ (brexanolone) Injection https://t.co/SVkYWhtxC3 (Twitter) - Jun 14, 2019
- | Zulresso (brexanolone) / Sage Therapeutics, Mayzent (siponimod) / Novartis, Sunosi (solriamfetol) / Jazz
Journal: Pharmaceutical Approval Update. (Pubmed Central) - Jun 6, 2019
No abstract available Sunosi (solriamfetol) tablets for excessive daytime sleepiness with narcolepsy or obstructive sleep apnea; Zulresso (brexanolone) injection for postpartum depression in adults; Mayzent (siponimod) tablets for adults with relapsing forms of MS.
- | Zulresso (brexanolone) / Sage Therapeutics
$SAGE Q1. ZULRESSO on track for launch in late June. Cash $1.4B (Twitter) - May 2, 2019
- |||||| Zulresso (brexanolone) / Sage Therapeutics
New trial: Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression (clinicaltrials.gov) - Apr 22, 2019
P, N=0, Available, Sponsor: Sage Therapeutics
- ||| Zulresso (brexanolone) / Sage Therapeutics
The findings on new postpartum depression drug, #brexanolone which described by one expert as "a revolution" in the care. https://t.co/dIYboDf3uY #EPA2019 (Twitter) - Apr 20, 2019
- ||| Zulresso (brexanolone) / Sage Therapeutics
The findings on new postpartum depression drug, brexanolone which described by one expert as "a revolution" in the care. https://t.co/5ty9W1h3Dv #EPA2019 (Twitter) - Apr 17, 2019
- | Zulresso (brexanolone) / Sage Therapeutics
New Drug Trial Snapshot available for Zulresso (brexanolone): https://t.co/yM8uHJg0j6. View PI @: https://t.co/LpRMrrE03f. (Twitter) - Apr 5, 2019
- ||| Zulresso (brexanolone) / Sage Therapeutics
L'@US_FDA ha approvato per la prima volta un farmaco contro la #depressione #postparto, il brexanolone. Una svolta decisiva per la vita di milioni di donne nel mondo colpite da un disturbo che ad oggi non disponeva di cure risolutive. #ANSASalute ➡ https://t.co/X34P2BrLCC (Twitter) - Apr 3, 2019
- ||||| Zulresso (brexanolone) / Sage Therapeutics
Clinical: A new pharmaceutical specifically for postpartum depression is approved and a large, ongoing study may yield insight into depression generally. @AmSciMag talks with @smeltzerb, the scientist who led clinical trials for the pharmaceutical https://t.co/85PF4gLivS #brexanolone (Twitter) - Apr 1, 2019
- ||| Zulresso (brexanolone) / Sage Therapeutics
Does this new postpartum depression drug signal a change in how general depression will be treated in the future? Dr. Samantha Meltzer-Brody @smeltzerb answers that question and shares her work with Zulresso. #Listen https://t.co/tbO2HHExma (Twitter) - Mar 27, 2019
- ||| Zulresso (brexanolone) / Sage Therapeutics
"We thought we would look to see if there was any kind of signal at all ... There was a rapid and robust response within 24 hours," @smeltzerb on testing Zulresso at UNC's Perinatal Psychiatry Program. (Twitter) - Mar 27, 2019
- |||| Zulresso (brexanolone) / Sage Therapeutics
Clinical: The new postpartum depression treatment Zulresso is expected to hit the market soon. @UNC professor Dr. Meltzer-Brody @smeltzerb was part of the clinical trials. She shares thoughts on what she calls a ground-breaking treatment in women's mental health. #listenlive on 91.5 @wunc. (Twitter) - Mar 27, 2019
- || Zulresso (brexanolone) / Sage Therapeutics
"Having a new treatment that has a new mechanism of action is incredibly exciting," @smeltzerb says of Zulresso. https://t.co/tSenVXGU1m (Twitter) - Mar 26, 2019
- ||| Zulresso (brexanolone) / Sage Therapeutics
This drug (Zulresso/ #brexanolone) may be the road to understanding treatment for depression more broadly than only postpartum depression, says @smeltzerb #AmSciTalks (Twitter) - Mar 26, 2019
- |||| Zulresso (brexanolone) / Sage Therapeutics
Clinical: Our #AmSciTalks speaker, @smeltzerb, was just on @OnPointRadio to talk about the new treatment for postpartum depression. She was the academic principal investigator for the clinical trials behind the treatment. #brexanolone #postpartum (Twitter) - Mar 26, 2019
- || Zulresso (brexanolone) / Sage Therapeutics
"Having a new treatment that has a new mechanism of action is incredibly exciting," @smeltzerb says of Zulresso. (Twitter) - Mar 26, 2019
- |||| Zulresso (brexanolone) / Sage Therapeutics
Clinical: At 12:30 p.m. Eastern, follow live tweets (#AmSciTalks) from a presentation by @smeltzerb, who led clinical trials behind the new and first treatment for postpartum depression, #brexanolone. Her talk: applying precision medicine to perinatal depression. https://t.co/bRHJjtm6LD (Twitter) - Mar 26, 2019
- | Keeping Track: Thumbs Up For Zulresso And Sunosi, Thumbs Down For Zynquista And IV Meloxicam https://t.co/bsYoNTQmCI #PinkSheet (Twitter) - Mar 25, 2019
- | Zulresso (brexanolone) / Sage Therapeutics, NN1213 / Novo Nordisk
Trial completion, Enrollment change: Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone (clinicaltrials.gov) - Dec 6, 2018
P2, N=6, Completed, Sponsor: Randi J. Hagerman, MD
Sunosi (solriamfetol) tablets for excessive daytime sleepiness with narcolepsy or obstructive sleep apnea; Zulresso (brexanolone) injection for postpartum depression in adults; Mayzent (siponimod) tablets for adults with relapsing forms of MS. Enrolling by invitation --> Completed | N=15 --> 6
- | Zulresso (brexanolone) / Sage Therapeutics
Enrollment change: A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) (clinicaltrials.gov) - Oct 9, 2018
P3, N=80, Recruiting, Sponsor: Sage Therapeutics
Enrolling by invitation --> Completed | N=15 --> 6 N=40 --> 80
- | Zulresso (brexanolone) / Sage Therapeutics
New P3 trial: A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) (clinicaltrials.gov) - Sep 11, 2018
P3, N=40, Recruiting, Sponsor: Sage Therapeutics
- ||||||| Zulresso (brexanolone) / Sage Therapeutics
Trial completion: A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B) (clinicaltrials.gov) - Nov 14, 2017
P3, N=138, Completed, Sponsor: Sage Therapeutics
N=40 --> 80 Active, not recruiting --> Completed
- ||||||| Zulresso (brexanolone) / Sage Therapeutics
Trial completion: A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C) (clinicaltrials.gov) - Nov 14, 2017
P3, N=108, Completed, Sponsor: Sage Therapeutics
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||| Zulresso (brexanolone) / Sage Therapeutics
Enrollment closed: A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B) (clinicaltrials.gov) - Oct 17, 2017
P3, N=120, Active, not recruiting, Sponsor: Sage Therapeutics
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||||| Zulresso (brexanolone) / Sage Therapeutics
Enrollment closed: A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C) (clinicaltrials.gov) - Oct 17, 2017
P3, N=100, Active, not recruiting, Sponsor: Sage Therapeutics
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||||||| Zulresso (brexanolone) / Sage Therapeutics
Trial completion: A Study With SAGE-547 for Super-Refractory Status Epilepticus (clinicaltrials.gov) - Sep 12, 2017
P3, N=132, Completed, Sponsor: Sage Therapeutics
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||||| Zulresso (brexanolone) / Sage Therapeutics
Enrollment closed: A Study With SAGE-547 for Super-Refractory Status Epilepticus (clinicaltrials.gov) - Aug 10, 2017
P3, N=140, Active, not recruiting, Sponsor: Sage Therapeutics
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||||| Zulresso (brexanolone) / Sage Therapeutics
Phase classification, Enrollment change: A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B) (clinicaltrials.gov) - Mar 3, 2017
P3, N=120, Recruiting, Sponsor: Sage Therapeutics
Recruiting --> Active, not recruiting Phase classification: P2 --> P3 | N=60 --> 120
- ||||| Zulresso (brexanolone) / Sage Therapeutics
Phase classification, Enrollment change: A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C) (clinicaltrials.gov) - Mar 3, 2017
P3, N=100, Recruiting, Sponsor: Sage Therapeutics
Phase classification: P2 --> P3 | N=60 --> 120 Phase classification: P2 --> P3 | N=36 --> 100
- | Zulresso (brexanolone) / Sage Therapeutics
Trial completion, Enrollment change: A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression (clinicaltrials.gov) - Oct 21, 2016
P2, N=21, Completed, Sponsor: Sage Therapeutics
Phase classification: P2 --> P3 | N=36 --> 100 Recruiting --> Completed | N=32 --> 21
- ||||| Zulresso (brexanolone) / Sage Therapeutics
New P2 trial: A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B) (clinicaltrials.gov) - Oct 20, 2016
P2, N=60, Recruiting, Sponsor: Sage Therapeutics
- | Zulresso (brexanolone) / Sage Therapeutics
New P2 trial: A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C) (clinicaltrials.gov) - Oct 20, 2016
P2, N=36, Recruiting, Sponsor: Sage Therapeutics
- | Zulresso (brexanolone) / Sage Therapeutics
Trial completion: Evaluate SAGE-547 in Participants With Essential Tremor (clinicaltrials.gov) - Jan 25, 2016
P2, N=24, Completed, Sponsor: Sage Therapeutics
Recruiting --> Completed | N=32 --> 21 Recruiting --> Completed
- | Zulresso (brexanolone) / Sage Therapeutics
Enrollment open: A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression (clinicaltrials.gov) - Jan 25, 2016
P2, N=32, Recruiting, Sponsor: Sage Therapeutics
Recruiting --> Completed Not yet recruiting --> Recruiting
- | Zulresso (brexanolone) / Sage Therapeutics
New P2 trial: A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression (clinicaltrials.gov) - Nov 25, 2015
P2, N=32, Not yet recruiting, Sponsor: Sage Therapeutics
- Zulresso (brexanolone) / Sage Therapeutics
New P2 trial: Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone (clinicaltrials.gov) - Nov 14, 2015
P2, N=15, Enrolling by invitation, Sponsor: University of California, Davis
- Zulresso (brexanolone) / Sage Therapeutics
Trial completion, Enrollment change, Trial primary completion date: Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression (clinicaltrials.gov) - Aug 13, 2015
P2, N=4, Completed, Sponsor: Sage Therapeutics
Not yet recruiting --> Recruiting Recruiting --> Completed | N=10 --> 4 | Trial primary completion date: Mar 2015 --> Jun 2015
- | Zulresso (brexanolone) / Sage Therapeutics
Trial completion, Enrollment change: Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus (clinicaltrials.gov) - Aug 13, 2015
P1/2, N=25, Completed, Sponsor: Sage Therapeutics
Recruiting --> Completed | N=10 --> 4 | Trial primary completion date: Mar 2015 --> Jun 2015 Recruiting --> Completed | N=40 --> 25
- |||||| Zulresso (brexanolone) / Sage Therapeutics
Enrollment open: A Study With SAGE-547 for Super-Refractory Status Epilepticus (clinicaltrials.gov) - Jul 23, 2015
P3, N=140, Recruiting, Sponsor: Sage Therapeutics
Recruiting --> Completed | N=40 --> 25 Not yet recruiting --> Recruiting
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics
New P3 trial: A Study With SAGE-547 for Super-Refractory Status Epilepticus (clinicaltrials.gov) - Jun 23, 2015
P3, N=140, Not yet recruiting, Sponsor: Sage Therapeutics
- Zulresso (brexanolone) / Sage Therapeutics
New trial: An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus (clinicaltrials.gov) - May 4, 2015
P=N/A, N=0, Available, Sponsor: Sage Therapeutics
- | Zulresso (brexanolone) / Sage Therapeutics
Enrollment change, Trial primary completion date: Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus (clinicaltrials.gov) - Nov 14, 2014
P1/2, N=40, Recruiting, Sponsor: Sage Therapeutics
Not yet recruiting --> Recruiting N=10 --> 40 | Trial primary completion date: Oct 2014 --> Jun 2015
- Zulresso (brexanolone) / Sage Therapeutics
New P2 trial: Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression (clinicaltrials.gov) - Nov 7, 2014
P2, N=10, Recruiting, Sponsor: Sage Therapeutics
- | Zulresso (brexanolone) / Sage Therapeutics
New P2 trial: Evaluate SAGE-547 in Participants With Essential Tremor (clinicaltrials.gov) - Oct 28, 2014
P2, N=24, Recruiting, Sponsor: Sage Therapeutics
- Zulresso (brexanolone) / Sage Therapeutics
New P1/2 trial: Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus (clinicaltrials.gov) - Jan 30, 2014
P1/2, N=10, Recruiting, Sponsor: Sage Therapeutics