Zurzuvae (zuranolone)

To treat postpartum depression  Press Release Drug Trials Snapshot

FDA Approval: 8/4/2023

Research Synopsis

  • Zuranolone (commercially known as Zurzuvae) is a neuroactive steroid being researched primarily for its potential in treating major depressive disorder (MDD) and postpartum depression (PPD).
  • Recent clinical trials, including a double-blind phase 3 study, have demonstrated that zuranolone significantly reduces depression scores compared to placebo, indicating strong efficacy and safety for PPD.
  • Zuranolone operates as a GABA receptor positive allosteric modulator, enhancing neural activity related to mood, which is different from traditional antidepressants that primarily target serotonin or norepinephrine systems.
  • Studies indicate that zuranolone exhibits a rapid onset of antidepressant effects, with significant improvements seen within 15 days of treatment, outperforming standard SSRIs and SNRIs.
  • In addition to its application in mood disorders, zuranolone has shown promise in preliminary trials for conditions like Parkinsonian tremors, where patients reported symptom improvement without serious side effects.
  • Safety profiles for zuranolone indicate that it is well tolerated, with mild side effects including dizziness and sedation noted, similar to those observed with other neuroactive steroids.
  • Research highlights that zuranolone could provide a rapid response for treating PPD, potentially allowing for better bridging to longer-term antidepressant therapies like SSRIs.
  • Ongoing studies are also evaluating the pharmacokinetics and optimal dosing of zuranolone, which has a favorable half-life allowing for flexible dosing regimens.
  • The growing body of evidence suggests that zuranolone could represent a significant advancement in the therapeutic landscape for PPD and MDD, expanding options for patients who do not respond well to conventional treatments.

Related articles

Research articles about Zurzuvae (zuranolone)

Zurzuvae (zuranolone)

Pharmacotherapy of Postpartum Depression: Current Approaches and Novel Drug Development.

London, UK

2 hours ago

1 Received

  • - Postpartum depression is a prevalent issue following childbirth that can negatively affect both mother and child's development if left untreated.
  • - Various treatments exist, including medications and therapies, but evidence supporting their efficacy is limited due to small studies and lack of long-term data.
  • - New treatments like brexanolone and SAGE-217, which target neuroactive steroids, have shown promise in clinical trials for rapidly reducing symptoms of postpartum depression.

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SAGE-217, A Novel GABA Receptor Positive Allosteric Modulator: Clinical Pharmacology and Tolerability in Randomized Phase I Dose-Finding Studies.

London, UK

2 hours ago

1 Received

  • SAGE-217 is a new drug designed to modulate GABA receptors and was tested in phase I studies to evaluate its safety and how it behaves in the body (pharmacokinetics) after being taken orally.
  • In these studies, 108 healthy volunteers participated, where doses ranged from 0.25 to 66 mg for single doses and 15 to 35 mg for multiple daily doses over a week; the drug was mostly well tolerated with mild side effects.
  • The drug's pharmacokinetics showed it has a half-life of 16-23 hours, and after successful results, SAGE-217 is moving on to phase II studies for treating major depressive disorder

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The impact of pregnancy on the pharmacokinetics of antidepressants: a systematic critical review and meta-analysis.

London, UK

2 hours ago

1 Received

  • Pregnancy alters how antidepressants are processed in the body, but existing research shows conflicting results regarding these changes.
  • A systematic review of studies found clear patterns in how levels of certain antidepressants change during pregnancy, especially in the third trimester, suggesting the need for dose adjustments.
  • Several antidepressants, like trimipramine and fluvoxamine, show significant decreases in dose-adjusted levels during pregnancy, while others, such as sertraline, may actually increase; however, the research has significant limitations, indicating the need for more studies on this topic.

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Intravenous brexanolone for postpartum depression: what it is, how well does it work, and will it be used?

London, UK

2 hours ago

1 Received

  • Postpartum depression affects about 10-20% of mothers globally, though actual rates may be higher due to stigma and underreporting.
  • Brexanolone is the first FDA-approved treatment for this condition, derived from allopregnanolone, which declines sharply after childbirth and is linked to postpartum depression.
  • The review will cover clinical trial results, efficacy, tolerability, and the practical use of brexanolone in treating postpartum depression.

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Announcing the novel class of GABA-A receptor selective positive allosteric modulator antidepressants.

London, UK

2 hours ago

1 Received

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Preclinical characterization of zuranolone (SAGE-217), a selective neuroactive steroid GABA receptor positive allosteric modulator.

London, UK

2 hours ago

1 Received

  • Zuranolone (SAGE-217) is a new synthetic drug that serves as a positive modulator of GABA receptors, designed for easy daily oral administration.
  • It enhances GABA receptor activity across various types and works synergistically with existing medications like diazepam, showing significant effects in both lab studies and animal models.
  • Currently being researched for its potential to treat mood disorders such as major depressive episodes and postpartum depression, zuranolone's clinical promise builds on the success of brexanolone, the first approved treatment for postpartum depression.

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$100 - $150

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Zuranolone as an oral adjunct to treatment of Parkinsonian tremor: A phase 2, open-label study.

London, UK

2 hours ago

1 Received

  • Parkinson's disease (PD) involves both motor and nonmotor symptoms, with tremor being difficult to treat, often not responsive to traditional dopamine therapy.
  • An open-label study tested zuranolone, a new oral treatment, on 14 PD patients over 7 days, focusing on reducing tremor symptoms measured by the MDS-UPDRS score.
  • Results showed a significant 40% improvement in tremor symptoms on Day 8 without serious side effects, with common mild adverse events including dizziness and sedation, suggesting zuranolone is a promising adjunct treatment for PD tremors.

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Understanding the Clinical Effects and Mechanisms of Action of Neurosteroids.

London, UK

2 hours ago

1 Received

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Number Needed to Treat and Number Needed to Harm analysis of the zuranolone phase 2 clinical trial results in major depressive disorder.

London, UK

2 hours ago

1 Received

  • Zuranolone (SAGE-217) is being researched as a new treatment for major depressive disorder (MDD), and a phase 2 study assessed its effectiveness compared to placebo and other antidepressants.
  • The results showed that zuranolone had a quicker response time, significantly outperforming placebo and showing better results than standard SSRIs and SNRIs on the 15th day of treatment.
  • Limitations include potential differences in study designs that might affect how broadly these findings apply, but overall, zuranolone appears to offer a favorable balance of benefits and reduced risks for MDD patients.

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Emerging Therapeutics Based on the Amino Acid Neurotransmitter System: An Update on the Pharmaceutical Pipeline for Mood Disorders.

London, UK

2 hours ago

1 Received

  • * Recent research highlights the importance of amino acid neurotransmitters as potential targets for new mood disorder treatments, moving beyond the monoamine hypothesis.
  • * The article reviews several drugs aimed at glutamate and GABA systems, discussing their progress in phase II and III clinical trials, emphasizing their potential as innovative therapies.

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Non-superiority of zuranolone (SAGE-217) at the longer-term.

London, UK

2 hours ago

1 Received

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Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial.

London, UK

2 hours ago

1 Received

  • Postpartum depression (PPD) is a prevalent medical issue affecting mothers and their children, leading to the need for effective treatments.* -
  • A phase 3 clinical trial tested zuranolone, a new drug, by comparing its effects to a placebo on women with PPD over a 2-week period.* -
  • Results showed that zuranolone significantly reduced depression scores compared to placebo, indicating its potential efficacy and safety for treating PPD.*

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Novel Oral Drug Rapidly Treats Postpartum Depression.

London, UK

2 hours ago

1 Received

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$100 - $150

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Review of Allopregnanolone Agonist Therapy for the Treatment of Depressive Disorders.

London, UK

2 hours ago

1 Received

  • The paper reviews the effectiveness and safety of allopregnanolone agonists, focusing on brexanolone and zuranolone for treating postpartum depression (PPD) and other depressive disorders.
  • Both brexanolone and zuranolone show promise in significantly lowering depression scores compared to placebo, but common side effects like sedation and dizziness are noted.
  • These medications may serve as quick solutions for PPD while potentially bridging to longer-term treatments like SSRIs, though further research is needed on their overall efficacy and application.

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The Neuroactive Steroid Pregnanolone Glutamate: Anticonvulsant Effect, Metabolites and Its Effect on Neurosteroid Levels in Developing Rat Brains.

London, UK

2 hours ago

1 Received

  • Pregnanolone glutamate (PA-G) is identified as a neuroactive steroid that shows potential as a neuroprotective compound and can inhibit certain receptors related to seizures.
  • The study found that PA-G has a strong anticonvulsant effect in young animals, reducing seizure severity, particularly in 12-day-old subjects, while showing varying effects at different ages.
  • Additionally, PA-G is metabolized into another compound, 17-hydroxy-pregnanolone (17-OH-PA), which may have significant neuroprotective properties and presents a potential area of study for perinatal neural diseases.

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Advances in pharmacotherapy for postpartum depression: a structured review of standard-of-care antidepressants and novel neuroactive steroid antidepressants.

London, UK

2 hours ago

1 Received

  • Postpartum depression is a common issue after childbirth, but it's often not diagnosed or treated properly, leading to negative effects for both mothers and their babies.
  • Standard antidepressants are usually prescribed, but they may take a long time to work and their effectiveness is not well-supported by evidence.
  • New treatments like gamma-aminobutyric acidergic neuroactive steroids show promise for quicker relief and better outcomes, and the article explores the safety of these and other hormonal therapies for breastfeeding mothers.

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A phase 1 double-blind, placebo-controlled study of zuranolone (SAGE-217) in a phase advance model of insomnia in healthy adults.

London, UK

2 hours ago

1 Received

  • This study aimed to assess the effectiveness of two doses of zuranolone (30 mg and 45 mg) in improving sleep in a phase advance insomnia model compared to a placebo.
  • In a double-blind crossover study, healthy adults were tested with three treatment periods and their sleep was measured using polysomnography and questionnaires.
  • Results showed that zuranolone significantly improved sleep metrics like sleep efficiency, wake after sleep onset, and total sleep time, with the drug being well tolerated overall, primarily causing mild side effects like headache and fatigue.

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Development of neuroactive steroids for the treatment of postpartum depression.

London, UK

2 hours ago

1 Received

  • Postpartum depression (PPD) is a prevalent mood disorder that affects 5.5% to 23.5% of new mothers in Europe and the USA, leading to serious consequences for both maternal well-being and infant development.
  • * Research indicates that hormonal fluctuations during and after pregnancy may disrupt GABA receptor function, contributing to PPD symptoms, although the exact causes are still unclear.
  • * Clinical studies have explored various treatments for PPD, including hormone therapy and medications that enhance GABA receptor activity, highlighting new avenues for effectively addressing this condition in women.

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The imidazodiazepine, KRM-II-81: An example of a newly emerging generation of GABAkines for neurological and psychiatric disorders.

London, UK

2 hours ago

1 Received

  • GABAkines are positive allosteric modulators of GABA receptors, used to treat conditions like anxiety, epilepsy, and sleep disorders; however, the development of new GABAkines had slowed down due to safety and side-effect concerns.
  • Recently, there has been renewed interest and progress in bringing new GABAkines to market, with the FDA approving brexanolone for post-partum depression in 2019 and several others currently in clinical development.
  • KRM-II-81 is highlighted as a promising new GABAkine with potential effectiveness against pharmacoresistant epilepsy, traumatic brain injury, and neuropathic pain, showing low sedation, no tolerance development, and anxiolytic and antidepressant-like

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