- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Ztalmy (ganaxolone oral) / Marinus, Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Review, Journal: New Directions in Neurosteroid Therapeutics in Neuropsychiatry. (Pubmed Central) - Apr 13, 2025
In this review, we explore GABAergic and other cellular effects of pregnane steroids including novel molecules that have potential therapeutic importance. This work discusses the complex chemical nature of NAS and what is being learned at cellular, molecular, synaptic and brain network levels about key sites of action including GABAARs and other targets.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Auvelity (bupropion/dextromethorphan) / Axsome Therap, Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Journal: Pharmacology of novel, fast-acting, non-monoaminergic antidepressants (Pubmed Central) - Apr 2, 2025
These novel treatment options pave the way for novel avenues for further research and new targets in the treatment of depression. Keywords: depression, antidepressant, glutamate, fast-acting antidepressant, non- monoaminergic antidepressant.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Review, Journal: An update on the pharmacotherapy of postpartum depression. (Pubmed Central) - Feb 13, 2025
For breastfeeding mothers reluctant to use pharmacotherapy, somatic therapy has been studied, including bright light therapy, vagal nerve stimulation, and newer noninvasive interventions. This article encompasses a short note on PPD, including its etiopathogenesis and clinical characteristics, and recapitulates the various available and evolving pharmacological and nonpharmacological therapies.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics
Trial completion date, Trial primary completion date: Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD (clinicaltrials.gov) - Jan 4, 2025
P2, N=256, Recruiting,
This review discusses transformative therapies that represent significant advancements in postpartum depression, major depressive disorder, and treatment-resistant depression. Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
- |||||||||| Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Journal: Current Developments in the Treatment of Postpartum Depression: Zuranolone. (Pubmed Central) - Dec 10, 2024
In addition, the newest drug approved by the FDA (Food and Drug Administration) for this condition is oral zuranolone. This review aims to analyze recent developments on zuranolone, the latest drug approved by the FDA for PPD, based on current studies.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics
Review, Journal: Clinical applications of small-molecule GABAAR modulators for neurological disorders. (Pubmed Central) - Dec 3, 2024
Neurosteroids such as allopregnanolone and its synthetic analogs, including Brexanolone, have emerged as potent GABAAR modulators with applications in conditions like postpartum depression and refractory epilepsy...Additionally, combining GABAAR modulators with other therapeutic agents has shown promise in enhancing efficacy and minimizing side effects. This review highlights the design strategies, pharmacodynamics, clinical efficacy, and safety profiles of these compounds, emphasizing the opportunities for developing novel GABAAR modulators with improved therapeutic outcomes.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Ztalmy (ganaxolone oral) / Marinus
Neuroactive Steroids Induce Sex Specific Effects on Intracellular Signaling via Activation of Membrane Progesterone Receptors (South Hall H - Level 1 - LACC) - Nov 26, 2024 - Abstract #AES2024AES_1272;
Additionally, the high potency of NAS for mPRs is at concentrations similar to endogenous ALLO in the brain and is below demonstrated plasma levels of FDA approved NAS treatments. Therefore, this work emphasizes the importance of understanding mPR signaling in the brain and the ability of mPRs to modulate neuronal inhibition to better develop future novel therapies.
- |||||||||| Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Review, Journal: Zuranolone for the Treatment of Postpartum Depression. (Pubmed Central) - Nov 17, 2024
Pharmacotherapeutic options to treat postpartum depression include selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors, with the medication brexanolone (the first allopregnanolone analogue) reserved for severe postpartum depression. Zuranolone, the newest medication in its class, is without the same limitations as brexanolone, thus affording providers an additional easy-to-use option for treating postpartum depression.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Addressing Postnatal Depression: Disparities in Treatment Availability () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1402;
In most countries, access to innovative treatments was limited due to the lack of policies, advocacy, and clinical trials. Severe side effects associated with brexanolone and zuranolone emphasised the urgent need for the development of newer therapies with improved safety profiles.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Addressing Postnatal Depression: Disparities in Treatment Availability () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_448;
In most countries, access to innovative treatments was limited due to the lack of policies, advocacy, and clinical trials. Severe side effects associated with brexanolone and zuranolone emphasised the urgent need for the development of newer therapies with improved safety profiles.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics
The role of allopregnanolone in GABAA receptor neuroadaptations in mice (MCP Hall A) - Aug 22, 2024 - Abstract #Neuroscience2024Neuroscience_916;
Traditionally selective serotonin reuptake inhibitors (SSRIs) served as the common antidepressants; however, recently brexanolone, a synthetic preparation of ALLO, was approved by the Food and Drug Administration (FDA) to specifically treat post-partum depression...Here, we have investigated inhibitory synaptic neuroadaptations after acute and chronic treatments of a sedative dose of ALLO using biochemical methods. We hope to provide deeper insight into the novel molecular mechanisms and pharmacological effects of ALLO treatment in GABAergic synapses in mice.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Review, Journal: Supportive care of female hormones in brain health: what and how? (Pubmed Central) - Aug 8, 2024
However, the potential risks and uncertainties associated with hormone therapy treatment modalities can be daunting for both patients and medical professionals. This review aims to offer a comprehensive understanding of the non-reproductive functions and mechanisms of female hormones in brain health.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Review, Journal: An update on approved and emerging drugs for the treatment of postpartum depression. (Pubmed Central) - Jul 31, 2024
Progesterone is one of these hormones and acts on the central nervous system starting from the fetal period; neurogenesis, neuromodulation, sedation are some of these effects...Brexanolone and zuranolone are synthetic allopregnanolone preparations approved by the FDA for use in female patients with postpartum depression...Their effectiveness has been demonstrated in patients with treatment-resistant depression. The development of other novel agents that act on the GABAA receptor and other pathways for the treatment of postpartum depression is in progress..
- |||||||||| Review, Journal: The Black Book of Psychotropic Dosing and Monitoring. (Pubmed Central) - Jul 12, 2024
While acetylcholinesterase inhibitors and memantine have been available for decades, these drugs modestly improve cognition in Alzheimer's disease patients and do not alter the progressive course of the illness...While it remains to be seen how useful these new agents will be in clinical practice, they do represent an approach to treating neuropsychiatric disorders that are a notable departure from the pharmacotherapy of the past half century. It seems likely that some patients who have not been able to respond to or tolerate traditional pharmacotherapy will find hope in these new medications.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Journal: Neurosteroids and translocator protein 18 (Pubmed Central) - Jul 8, 2024
The first FDA-approved 3?-reduced steroid for postpartum depression is brexanolone, an intravenous formulation of allopregnanolone...An orally available 3?-reduced steroid is zuranolone, which also received FDA approval in 2023 for the treatment of postpartum depression...Studies are underway to evaluate its antidepressant potential. Hopefully, neurosteroid research will lead to the development of fast-acting antidepressants.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Ztalmy (ganaxolone oral) / Marinus, Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Review, Journal: Understanding and treating postpartum depression: a narrative review. (Pubmed Central) - Jun 28, 2024
Newer neurosteroids such as ganaxolone, valaxanolone, and lysaxanolone are currently under development, but also esketamine and psychedelics are promising potential treatments...PPD is therefore increasingly understood as, at least partially, independent from major depressive disorder. Specific and individualized treatments including pharmacological and non-pharmacological therapies are progressively being introduced in the routine clinical practice.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics
Journal: Gut bacteria convert glucocorticoids into progestins in the presence of hydrogen gas. (Pubmed Central) - Jun 8, 2024
Levels of certain bacterial progestins, including allopregnanolone, better known as brexanolone, an FDA-approved drug for postpartum depression, are substantially increased in feces from pregnant humans. Thus, bacterial conversion of corticoids into progestins may affect host physiology, particularly in the context of pregnancy and women's health.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, pregnenolone / Duke University Health System
Review, Journal, IO biomarker: Neuroactive Steroids, Toll-like Receptors, and Neuroimmune Regulation: Insights into Their Impact on Neuropsychiatric Disorders. (Pubmed Central) - May 25, 2024
Clinical studies highlight their therapeutic potential, particularly in conditions like postpartum depression (PPD), where the FDA-approved compound brexanolone, an intravenous formulation of allopregnanolone, effectively suppresses TLR-mediated inflammatory pathways, predicting symptom improvement...This review emphasizes the significant therapeutic potential of neuroactive steroids in modulating TLR signaling pathways, particularly in addressing inflammatory processes associated with neuropsychiatric disorders. It advances our understanding of the complex interplay between neuroactive steroids and immune responses, paving the way for personalized treatment strategies tailored to individual needs and providing insights for future research aimed at unraveling the intricacies of neuropsychiatric disorders.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics
Trial completion date, Trial primary completion date: An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder (clinicaltrials.gov) - May 22, 2024
P4, N=20, Recruiting,
It advances our understanding of the complex interplay between neuroactive steroids and immune responses, paving the way for personalized treatment strategies tailored to individual needs and providing insights for future research aimed at unraveling the intricacies of neuropsychiatric disorders. Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2024 --> Dec 2025
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Preclinical, Journal: Neurosteroid Modulation of Synaptic and Extrasynaptic GABAA Receptors of the Mouse Nucleus Accumbens. (Pubmed Central) - Apr 27, 2024
Furthermore, we demonstrate local neurosteroid synthesis in the accumbal slice preparation and reveal that GABA-ergic neurotransmission of MSNs is influenced by an endogenous neurosteroid tone. Given the dramatic fluctuations in allopregnanolone levels during pregnancy and postpartum, this neurosteroid-mediated local fine-tuning of GABAergic transmission in the MSNs will probably be perturbed.
- |||||||||| FDA event, Review, Journal: A Comprehensive Review of Novel FDA-Approved Psychiatric Medications (2018-2022). (Pubmed Central) - Apr 22, 2024
Given the dramatic fluctuations in allopregnanolone levels during pregnancy and postpartum, this neurosteroid-mediated local fine-tuning of GABAergic transmission in the MSNs will probably be perturbed. We found 12 novel psychiatric medications approved by the FDA from 2018 to 2022, representing a very small percentage of the total FDA approvals during that
- |||||||||| Zurzuvae (zuranolone) / Sage Therapeutics, Biogen
Journal: Exploring the clinical potentials of zuranolone in managing postpartum depression: A new therapeutic horizon. (Pubmed Central) - Apr 15, 2024
The implementation of zuranolone in treating PPD can prove to be revolutionary considering it is the first oral medication available for PPD. Our paper aims to discuss the various clinical trials that have been conducted that validate the efficacy of zuranolone in mitigating the symptoms of PPD, hence, leading to better outcomes for mothers.
- |||||||||| Zurzuvae (zuranolone) / Sage Therapeutics, Shionogi, Biogen
Journal: Zuranolone (Zurzuvae) - An oral drug for postpartum depression. (Pubmed Central) - Dec 26, 2023
The identified drugs may be potential repurposing candidates against pseudomonal infections through inhibition of las-r protein.Communicated by Ramaswamy H. Sarma. No abstract available
- |||||||||| lithium carbonate ER / Generic mfg.
Journal: Drugs for depressionr. (Pubmed Central) - Dec 26, 2023
No abstract available No abstract available
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus (clinicaltrials.gov) - Dec 22, 2023
P2, N=10, Completed,
No abstract available Active, not recruiting --> Completed | N=24 --> 10 | Trial completion date: Apr 2024 --> Nov 2023 | Trial primary completion date: Apr 2024 --> Nov 2023
- |||||||||| Zurzuvae (zuranolone) / Sage Therapeutics, Shionogi, Biogen
Review, Journal: Zuranolone - synthetic neurosteroid in treatment of mental disorders: narrative review. (Pubmed Central) - Dec 20, 2023
Neurosteroids are progesterone metabolites that are synthesized from cholesterol or steroid hormones in various brain regions...Zuranolone, a newly registered neurosteroid drug has shown huge flexibility in both clinical and ambulatory treatment thanks to its pharmacokinetic traits, especially the possibility for oral administration, unlike its predecessor Brexanolone...The review also explores the potential relevance of neurosteroids for other psychiatric disorders, such as major depression, bipolar disorder, post-traumatic stress disorder (PTSD), schizophrenia, and premenstrual dysphoric disorder. Finally, it highlights the associations between neurosteroid levels and symptom severity and the effects of neurosteroid modulation on mood, cognition, and neuroplasticity.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics
Enrollment closed: An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus (clinicaltrials.gov) - Dec 15, 2023
P2, N=24, Active, not recruiting,
Finally, it highlights the associations between neurosteroid levels and symptom severity and the effects of neurosteroid modulation on mood, cognition, and neuroplasticity. Recruiting --> Active, not recruiting
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Ztalmy (ganaxolone oral) / Marinus, Zurzuvae (zuranolone) / Sage Therapeutics, Shionogi, Biogen
Review, Journal: Novel neurosteroid therapeutics for post-partum depression: perspectives on clinical trials, program development, active research, and future directions. (Pubmed Central) - Dec 11, 2023
Finally, we describe new and future directions in neurosteroid therapeutics, including the development of an oral agent, zuranolone, and the IV and oral formulations of ganaxolone. Ultimately, the hope is that these novel neurosteroid therapeutics will provide fast-acting treatment for these impairing disorders and improve our understanding of the underlying mechanisms of depressive disorders.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics
Journal: Meta-Analyses of Genome-Wide Association Studies for Postpartum Depression. (Pubmed Central) - Dec 4, 2023
There is also evidence that despite a high correlation with MDD, PPD may have unique genetic components. Cell enrichment results suggest GABAergic neurons, which converge on a common mechanism with the only medication approved by the U.S. Food and Drug Administration for PPD (brexanolone).
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Spravato (esketamine intranasal) / J&J, Auvelity (bupropion/dextromethorphan) / Axsome Therap
Review, Journal: Pharmacotherapies Targeting GABA-Glutamate Neurotransmission for Treatment-Resistant Depression. (Pubmed Central) - Nov 25, 2023
Of the compounds reviewed here, three are approved by the Food and Drug Administration (FDA): esketamine (Spravato) for TRD, Auvelity (dextromethorphan-bupropion) for major depressive disorder (MDD), and brexanolone (Zulresso) for post-partum depression (PPD). Notably, some concerns have arisen with esketamine and brexanolone, which will be detailed in this study.
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Zurzuvae (zuranolone) / Sage Therapeutics, Shionogi, Biogen
Review, Journal: Current pharmacotherapy approaches and novel GABAergic antidepressant development in postpartum depression. (Pubmed Central) - Oct 9, 2023
Novel antidepressant development with allopregnanolone analogues, in contrast, has proven a promising avenue for the development of rationally designed and efficacious treatments. This state-of-the-art review presents the evidence for the current standard-of-care pharmacotherapy, hormonal treatment, and emerging allopregnanolone analogues for the treatment of postpartum depression along with a discussion of the current understanding of its neuroactive steroid-driven pathophysiology.
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