A phase 3 study of S-812217 in combination with an antidepressant in patients with major depressive disorder consisting of randomized, double-blind, placebo-control part and extension, open-label, re-treatment part

Start Date01 Nov 2022

Sponsor / Collaborator-

JPRN-jRCT2031210577 / Not yet recruitingPhase 3IIT

A phase 3 study of S-812217 in patients with major depressive disorder consisting of randomized, double-blind, placebo-control part and extension, open-label, re-treatment part

Start Date08 Mar 2022

Sponsor / Collaborator-

100 Clinical Results associated with Zuranolone

100 Translational Medicine associated with Zuranolone

100 Patents (Medical) associated with Zuranolone

Literatures (Medical) associated with Zuranolone

31 Dec 2024·Journal of medical economics

The cost-effectiveness of zuranolone versus selective serotonin reuptake inhibitors for the treatment of postpartum depression in the United States

Article

Author: Deligiannidis, Kristina M. ; O’Callaghan, Lasair ; Chertavian, Elizabeth ; Ferries, Erin ; Johnson, Scott J.

AIMS:

The objective of this research is to evaluate the cost-effectiveness of zuranolone, the first oral treatment indicated for postpartum depression (PPD) in adults approved by the United States Food and Drug Administration.

METHODS:

Zuranolone and selective serotonin reuptake inhibitor (SSRI) trial-based efficacy was derived from an indirect treatment comparison. Long-term efficacy outcomes were based on a large longitudinal cohort study. Maternal health utility values were derived from trial-based, short-form 6-D responses. Other inputs were derived from literature and economic data from the US Bureau of Labor Statistics. We estimated costs (2023 US dollars) and quality-adjusted life-years (QALYs) for patients with PPD treated with zuranolone (14-day dosing) or SSRIs (chronic dosing). The indirect costs and QALYs of the children and partners were also estimated.

RESULTS:

The incremental cost-effectiveness ratio for zuranolone versus SSRIs was $94,741 per QALY gained over an 11-year time horizon. Maternal total direct medical costs averaged $84,318 in the zuranolone arm, compared to $86,365 in the SSRI arm. Zuranolone-treated adults averaged 6.178 QALYs compared to 6.116 QALYs for the SSRI arm. Costs and utilities for the child and partner were also included in the base case. Drug and administration costs for zuranolone averaged $15,902, compared to $30 for SSRIs over the studied time horizon. Results were sensitive to the model time horizon.

LIMITATIONS:

As head-to-head trials were not available to permit direct comparison, efficacy inputs were derived from an indirect treatment comparison which can be confounded by cross-trial differences. The data used are reflective of a general PPD population rather than marginalized individuals who may be at a greater risk for adverse PPD outcomes. The model likely excludes unmeasured effects for patient, child, and partner.

CONCLUSIONS:

This economic model's results suggest that zuranolone is a more cost-effective therapy compared to SSRIs for treating adults with PPD.

31 Dec 2024·Journal of medical economics

Indirect comparisons of relative efficacy estimates of zuranolone and selective serotonin reuptake inhibitors for postpartum depression

Review

Author: Roskell, Neil ; Smith, Sarah ; Toubouti, Youssef ; Deligiannidis, Kristina M ; Tan, Robin ; Gerbasi, Margaret E ; Mak, Catherine ; Chen, Shih-Yin Sharon ; Meltzer-Brody, Samantha

AIMS:

Estimate relative efficacy of zuranolone, a novel oral, Food and Drug Administration-approved treatment for postpartum depression (PPD) in adults vs. selective serotonin reuptake inhibitors (SSRIs) and combination therapies used for PPD in the United States.

MATERIALS AND METHODS:

Randomized controlled trials (RCTs) for zuranolone and SSRIs, identified from systematic review, were used to construct evidence networks, linking via common comparator arms. Due to heterogeneity in placebo responses, matching-adjusted indirect comparison (MAIC) was applied, statistically weighting the zuranolone treatment arm of Phase 3 SKYLARK Study (NCT04442503) to the placebo arm of RCTs investigating SSRIs for PPD. MAIC outputs were applied in Bucher indirect treatment comparisons (ITCs) and network meta-analysis (NMA), using Edinburgh Postnatal Depression Scale (EPDS) and 17-item Hamilton Rating Scale for Depression (HAMD-17) change from baseline (CFB) on Days 3, 15, 28 (Month 1), 45, and last observation (Day 45, Week 12/18).

RESULTS:

Larger EPDS CFB was observed among zuranolone-treated vs. SSRI-treated patients from Day 15 onward. Zuranolone-treated (vs. SSRI-treated) patients exhibited 4.22-point larger reduction in EPDS by Day 15 (95% confidence interval: -6.16, -2.28) and 7.43-point larger reduction at Day 45 (-9.84, -5.02) with Bucher ITC. NMA showed EPDS reduction for zuranolone was 4.52 (-6.40, -2.65) points larger than SSRIs by Day 15 and 7.16 (-9.47, -4.85) larger at Day 45. Lack of overlap between study populations substantially reduced effective sample size post-matching, making HAMD-17 CFB analysis infeasible.

LIMITATIONS:

Limited population overlap between SKYLARK Study and RCTs reduced feasibility of undertaking HAMD-17 CFB ITCs and may introduce uncertainty to EPDS CFB ITC results.

CONCLUSIONS:

Analysis showed zuranolone-treated patients with PPD experienced greater symptom improvement than SSRI-treated patients from Day 15 onward, with largest mean difference at Day 45. Adjusting for differences between placebo arms, zuranolone may be associated with greater PPD symptom improvement (measured by EPDS) vs. SSRIs.

01 Dec 2024·JOURNAL OF PSYCHOPHARMACOLOGY

Cognitive effects, pharmacokinetics, and safety of zuranolone administered alone or with alprazolam or ethanol in healthy adults in a phase 1 trial

Article

Author: Maruff, Paul ; Czysz, Andy ; Nandy, Indrani ; Moseley, Margaret K ; Walling, David P ; Jain, Rakesh ; Ona, Victor ; Dunbar, Joi ; Hassman, Howard A ; Levin, Seth

Background::

Zuranolone is an oral, once-daily, 14-day treatment course approved for adults with postpartum depression in the United States.

Aims::

To assess cognitive effects, pharmacokinetics, and safety of zuranolone, alone or with alprazolam/ethanol.

Methods::

This was a phase 1, two-part, two-period, randomized, double-blind, placebo-controlled crossover trial. Participants received zuranolone 50 mg or placebo once daily for 9 days, and additionally received alprazolam (1 mg, Part A), ethanol (males: 0.7 g/kg; females: 0.6 g/kg, Part B), or corresponding placebo on days 1, 5, and 9. Within each part, participants received all treatment combinations. Cognition was assessed using a computerized test battery; pharmacokinetics and safety were also evaluated.

Results::

All participants (Part A, N = 24; Part B, N = 25) received ⩾1 dose of zuranolone/placebo. Compared to placebo, zuranolone produced small-to-moderate cognitive decline (Cohen’s | d| = 0.126–0.76); effects were larger with alprazolam (Cohen’s | d| = 0.523–0.93) and ethanol (Cohen’s | d| = 0.345–0.88). Zuranolone coadministration with alprazolam (Cohen’s | d| = 0.6–1.227) or ethanol (Cohen’s | d| = 0.054–0.5) generally worsened cognitive decline when compared with zuranolone alone. Maximal pharmacodynamic effects occurred at approximately 5 h and were resolved by 12 h postbaseline. No pharmacokinetic interactions were observed. Incidence of adverse events was similar between groups; most events were mild or moderate in severity.

Conclusion::

A general small-to-moderate magnitude decline in cognition occurred with zuranolone alone. Coadministration with alprazolam/ethanol increased the magnitude, but not the duration, of effects compared with single-agent administration. Zuranolone prescribers and patients should be aware of the potential for increased central nervous system-depressant effects if coadministered with GABAergic active compounds such as alprazolam and ethanol.

174

News (Medical) associated with Zuranolone

25 Nov 2024

·www.prnewswire.com

Major Depressive Disorder Market to Register Immense Growth by 2034 Owing to a Robust Pipeline | DelveInsight

With the anticipated introduction of new treatments such as COMP360 (COMPASS Pathways), Zuranolone (SAGE Therapeutics/Biogen), LY03005 (Luye Pharma), REL-1017 (Relmada Therapeutics), Seltorexant (Minerva Neurosciences/Janssen Pharmaceutical), ABV-1504 (BioLite/ABVC BioPharma), and other and increasing disease awareness, it's reasonable to expect a significant transformation in the major depressive disorder market in the coming years. LAS VEGAS, Nov. 25, 2024 /PRNewswire/ -- Major depressive disorder (MDD), commonly referred to as depression, is a serious medical condition that affects a person's mood, behavior, thinking, and physical well-being. It is different from the temporary feelings of sadness that everyone experiences and should not be confused with the deep grief following the loss of a loved one. MDD is typically a recurrent and episodic condition, meaning that someone who has experienced depression and recovered is likely to face additional episodes, often within 2 to 3 years. As per DelveInsight analysis, the total diagnosed prevalent cases of MDD in the 7MM were found to be approximately 44 million cases in 2023, which is expected to increase during the forecast period (2024–2034). Among the severity-specific diagnosed prevalent cases of MDD, the highest prevalence was observed in moderate cases accounting for approximately 17 million cases in the 7MM in 2023 followed by severe cases and mild cases. Major depressive disorder can be addressed through several treatment approaches, including pharmacological interventions, psychotherapy, interventional methods, and lifestyle changes. Initial treatment often involves either medication, psychotherapy, or a combination of both, with combined therapy proving more effective than using either alone. For severe cases of major depression, electroconvulsive therapy is the most effective option. The current range of recommended pharmacological treatments for major depressive disorder primarily includes antidepressants such as monoamines, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), and selective reuptake inhibitors, including medications like VRAYLAR, BRINTELLIX (now TRINTELLIX), SPRAVATO, REXULTI, and FETZIMA. In the upcoming major depressive disorder treatment market landscape, there are a plethora of companies investigating agents for use in major depressive disorder which includes Sage Therapeutics, Relmada Therapeutics, Johnson & Johnson Services, Inc., Biogen, COMPASS Pathways, Luye Pharma, and others. Many more pharma companies are conducting clinical trials for therapies for major depressive disorder. To know more about upcoming major depressive disorder therapies showing positive results, visit @ Drugs for Major Depressive Disorder Treatment DelveInsight estimates that the market size for major depressive disorder is expected to grow from USD 7.1 billion in 2023 with a significant CAGR by 2034. The disease awareness and the emergence of new products in the pipeline will add to the market growth in the future. In addition, persistently rising cases of MDD in the forecast period will contribute to the rise in the MDD treatment market. The current pipeline for major depressive disorder includes a range of drugs with diverse mechanisms of action (MoA). COMP360 (COMPASS Pathways) , Zuranolone (SAGE Therapeutics/Biogen) , LY03005 (Luye Pharma) , REL-1017 (Relmada Therapeutics) , seltorexant (Minerva Neurosciences/Janssen Pharmaceutical) , ABV-1504 (BioLite/ABVC BioPharma), and some others are the most promising drugs of this indication. Ongoing research and current trials have the potential to change the MDD market. Keen to know how the MDD market will evolve by 2034? Find out @ Major Depressive Disorder Market Report The potential for effective major depressive disorder treatment in the future is expected to grow with the addition of numerous drugs to the pipeline of new therapeutics. Currently, a variety of candidate drugs for the treatment of major depressive disorder are being tested in various clinical trials, with some showing positive results. Any drug approved with increased safety and efficacy is expected to cause significant changes in the overall major depressive disorder market. Now, let's examine the pipeline therapies under investigation for major depressive disorder COMP360: COMPASS Pathways Phase III COMPASS Pathways is investigating the use of its experimental psilocybin therapy, COMP360, for treating serious mental health conditions like major depressive disorder. COMP360 is a synthesized version of psilocybin, the active compound found in certain "magic mushrooms," and is administered alongside psychological support. Psilocybin has shown promise in therapeutic applications, and COMP360 has been granted Breakthrough Therapy status by the US FDA as well as an Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Currently, COMPASS Pathways is running a Phase II trial for MDD, with a Phase III trial underway in partnership with Massachusetts General Hospital to further explore its potential in meeting mental health treatment needs. The company is anticipated to release top-line data from two key trials, COMP005 and COMP006, by the fourth quarter of 2024 and mid-2025, respectively, for the treatment of TRD. Zuranolone: SAGE Therapeutics/Biogen Phase III Zuranolone, being developed by SAGE Therapeutics and Biogen, is a next-generation oral, highly potent, and selective positive allosteric modulator, designed for specific targeting of synaptic and extrasynaptic GABAA receptors. The binding sites for neuroactive steroids (NASs) are different from those for GABA, benzodiazepines, and barbiturates. The GABA system, which is the primary inhibitory signaling pathway in the brain and central nervous system (CNS), plays a key role in regulating CNS function. SAGE-217 is currently in phase III clinical development for major depressive disorder and is being evaluated through the LANDSCAPE and NEST clinical trial programs, which include multiple studies involving thousands of participants, with varying dosing regimens, clinical endpoints, and treatment approaches. In February 2023, the US FDA accepted the New Drug Application (NDA) for zuranolone in the treatment of MDD. However, in August 2023, the FDA issued a Complete Response Letter (CRL) regarding the NDA for zuranolone for treating adults with MDD. Sage and Biogen are now assessing the feedback and determining their next steps. LY03005: Luye Pharma LY03005, developed by Luye Pharma, is one of the company's key products in the CNS therapeutic space. It is their exclusive extended-release tablet formulation of ansofaxine hydrochloride, a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) designed for treating major depressive disorder. LY03005 aims to offer improved efficacy and fewer side effects compared to conventional antidepressants like SSRIs and SNRIs. Ansofaxine, a prodrug of desvenlafaxine, strongly inhibits dopamine reuptake in addition to serotonin and norepinephrine, demonstrating superior efficacy in clinical trials. In March 2020, the US FDA accepted the NDA submission for LY03005, which is currently in Phase III pivotal clinical trials for MDD treatment. Seltorexant: Minerva Neurosciences/Janssen Pharmaceutical Phase III Seltorexant, developed by Minerva Neurosciences and Janssen Pharmaceutical, is a selective orexin-2 receptor antagonist intended as an adjunctive treatment for major depressive disorder and for managing insomnia. It is the most advanced ORX2-specific molecule in clinical development, acting as an antagonist by binding to its receptor. Seltorexant is being studied for two main uses: insomnia without psychiatric disorders and MDD in patients who do not respond adequately to SSRIs or SNRIs. In May 2024, Johnson & Johnson reported positive topline results from the pivotal Phase III MDD3001 trial, which assessed its efficacy and safety as an add-on therapy to antidepressants in adults and elderly MDD patients. Discover which therapies are expected to grab major MDD market share @ New Treatments for Major Depressive Disorder REL-1017: Relmada Therapeutics Phase III REL-1017, being developed by Relmada Therapeutics, is a novel chemical entity (NCE) and an NMDA receptor (NMDAR) channel blocker that specifically targets overactive channels while preserving normal glutamatergic neurotransmission. The U.S. FDA has granted it Fast Track Designation as an immunotherapy for treating major depressive disorder. In a Phase II trial, REL-1017 exhibited rapid, strong, and lasting antidepressant effects, with statistically significant improvements over placebo in depression measures. The study also indicated a favorable safety, tolerability, and pharmacokinetic profile for the drug. Currently, it is in late-stage development for MDD, being tested in Phase III trials for both adjunctive and monotherapy. In June 2024, Relmada published clinical data from the Reliance I Study. The company is actively enrolling patients in ongoing trials for REL-1017, including Reliance II (Study 302), with top-line results expected in the latter half of 2024, and Relight (Study 304), which is anticipated to provide results about six months after the completion of Study 302. ABV-1504: ABVC BioPharma Phase II ABV-1504, developed by ABVC BioPharma, features PDC-1421 as its active ingredient and is classified as a botanical investigational new drug. Through its subsidiary BioLite, ABVC has completed a Phase II trial of ABV-1504, a botanical Norepinephrine Transporter (NET) inhibitor. This trial, conducted at Stanford University, showed that the PDC-1421 capsule was safe and well-tolerated among six enrolled adult patients. Both low and high doses of PDC-1421 successfully achieved the study's primary endpoints, showing a necessary 40% improvement in ADHD-RS-IV test scores. In April 2023, PDC-1421 was awarded a US patent (US 11,554,154 B2) for the treatment of Major Depressive Disorder (MDD). The drug has also completed a Phase II trial in MDD patients, and the company intends to hold an End of Phase II (EOP II) meeting with the FDA in the near future. Itruvone (PH10): VistaGen Therapeutics Phase II Itruvone (PH10), being developed by VistaGen Therapeutics, is an investigational first-in-class synthetic neurosteroid that is odorless and fast-acting, showing promise for various neuropsychiatric conditions related to depression and suicidal thoughts. VistaGen is focusing on PH10 as a potential quick-acting, non-sedating, and non-addictive treatment for MDD that patients can conveniently self-administer at home. When self-administered, a microgram-level dose of PH10 sprayed into the nose interacts with nasal chemosensory receptors, activating brain neural circuits to produce rapid antidepressant effects without the side effects, systemic exposure, or safety issues associated with FDA-approved treatments for MDD, such as oral antidepressants and esketamine. After successfully completing Phase IIa trials for MDD, VistaGen is now gearing up for the planned Phase IIb clinical development of PH10 for this condition. Moreover, in December 2022, PH10 received fast-track designation from the US FDA. LPCN 1154: Lipocine Phase II LPCN 1154, developed by Lipocine, is an oral formulation of brexanolone designed for rapid relief of postpartum depression. Its active ingredient is a naturally occurring positive allosteric modulator of the GABAa receptor. This medication is intended to provide an "at-home" treatment option, making it more accessible than the current standard care, which involves invasive procedures and hospitalization. In September 2022, the FDA approved Lipocine's proposal to demonstrate the efficacy of LPCN 1154 through a single pivotal pharmacokinetic bridge to the approved IV infusion of brexanolone via a 505(b)(2) NDA submission. In June 2024, Lipocine announced positive topline results from a pivotal pharmacokinetic study, confirming that LPCN 1154 is bioequivalent to IV brexanolone for PPD treatment. Lipocine aims to submit the NDA by the end of the fourth quarter of 2024. Discover more about drugs for major depressive disorder in development @ Major Depressive Disorder Clinical Trials DelveInsight's latest published market report titled as Major Depressive Disorder Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the major depressive disorder country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The major depressive disorder market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of MDD Gender-specific Diagnosed Prevalent Cases of MDD Severity-specific Diagnosed Prevalent Cases of MDD The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM major depressive disorder market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this major depressive disorder market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the major depressive disorder market. Also, stay abreast of the mitigating factors to improve your market position in the major depressive disorder therapeutic space. Related Reports Major Depressive Disorder Pipeline Major Depressive Disorder Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key major depressive disorder companies, including GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, among others. Treatment-Resistant Depression Market Treatment-Resistant Depression Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key TRD companies, including Navitor Pharmaceuticals, Supernus Pharmaceuti, Novartis, Relmada Therapeutics, Beckley Psytech, COMPASS Pathways, Axsome Therapeutics, Celon Pharma, among others. Treatment-Resistant Depression Pipeline Treatment-Resistant Depression Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key treatment-resistant depression companies, including Axsome Therapeutics, COMPASS Pathways, Merck Sharp & Dohme Corp., Navitor Pharmaceuticals, Inc., Taisho Pharmaceutical Co., Ltd., GH Research Limited, Novartis Pharmaceuticals, Reckitt Benckiser LLC, Relmada Therapeutics, Inc., SAGE Therapeutics, Navitor Pharmaceuticals, Sumitomo Dainippon Pharma, Alkermes, AbbVie, Janssen Pharmaceuticals, Celon Pharma, ACADIA Pharmaceuticals, Pherin Pharmaceuticals, ATAI Life Sciences, among others. Postpartum Depression Market Postpartum Depression Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key postpartum depression companies, including Sage Therapeutics, Epharmix, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3Clinical ResultFast TrackBreakthrough Therapy

20 Nov 2024

·endpts.com

Sage reports Phase 2 failure in Huntington's disease, ends drug's development

Sage’s final hope to turn its business around has failed, leaving the future of the once high-flying company and its postpartum depression drug uncertain. The company announced Wednesday morning that a Phase 2 study for dalzanemdor, previously known as SAGE-718, failed in Huntington’s disease, saying it missed the primary and all secondary endpoints. As a result, Sage will stop all further dalzanemdor development and suspend an ongoing open-label safety study in Huntington’s. With the failure, Sage has no remaining ongoing clinical trials. The company scuttled the rest of its pipeline and some early-stage research last month, its second restructuring since August 2023, when its postpartum depression drug Zurzuvae won approval but was also rejected in the broader major depression population. Zurzuvae notched $11 million in third-quarter sales. A spokesperson told Endpoints News in an email that Sage will use the study “to inform our go-forward R&D strategy and continue to evaluate options across our early-stage pipeline, including SAGE-319,” a program the company says is in Phase 1 development but does not appear on the clinicaltrials.gov registry. Zurzuvae remains Sage’s “core strategic focus,” the spokesperson added. Wednesday’s readout comes after warning signs flashed on dalzanemdor all year. In July, Sage adjusted the primary endpoint in the trial after a separate study showed only a “small numerical difference” between the drug and placebo on the previous primary endpoint, which measured cognitive decline. Dalzanemdor also failed to improve cognition in mid-stage studies of Alzheimer’s and Parkinson’s disease , but execs and analysts believed the Huntington’s trial had been the drug’s best shot at success. The new primary endpoint also looked at cognition but was focused on a subgroup of the original measurement, a broader composite cognitive assessment called HD-CAB. Sage’s stock price $SAGE fell as much as 18% in Wednesday’s premarket session, but rose to about a 2% decline off Tuesday’s close before trading was halted.

Phase 2Drug ApprovalPhase 1

20 Nov 2024

·firstwordpharma.com

End of the road for Sage's dalzanemdor after third study failure

Sage Therapeutics has definitively ended development of dalzanemdor (SAGE-718), its experimental cognitive impairment drug, after the compound failed to demonstrate meaningful efficacy in a Phase II Huntington's disease study. The decision marks the final chapter for a drug that has disappointed in trials this year targeting Alzheimer's as well as Parkinson's disease.On Wednesday, Sage announced that the DIMENSION study, a 12-week placebo-controlled trial involving 189 patients with cognitive impairment associated with Huntington's, did not meet its primary endpoint of improving cognitive function as measured by change from baseline on the Symbol Digit Modalities Test (SDMT) at day 84. Secondary endpoint analyses similarly showed no statistically significant or clinically meaningful differences between dalzanemdor and placebo.Dalzanemdor, an NMDA receptor positive allosteric modulator, was initially seen as a potential breakthrough in treating cognitive impairment across multiple neurological conditions."We are disappointed by the results of the DIMENSION study, especially for the individuals and families affected by Huntington's disease who have long awaited new treatment options," said CEO Barry Greene. The company will also close its ongoing PURVIEW open-label safety study related to the drug.The repeated clinical failures come amid a significant shake-up at Sage. Last month, the company announced plans to cut a third of its workforce, roughly 165 employees, including over half of its R&D staff, as it tries to regroup to focus on its Biogen-partnered postpartum depression drug Zurzuvae (zuranolone). In a note to clients earlier this month, Mizuho analysts had "low confidence" about the DIMENSION readout, which they said would "be followed by a catalyst-scarce period next year as Sage works through its early-stage pipeline re-prioritisation." Although the analysts were encouraged by the progress of Zurzuvae's launch, which recently saw 40% growth quarter-over-quarter, they remain "cautious" about forecasting more than $300 million in peak sales for the post-partum drug "before having better visibility on potential adoption."

Phase 2Clinical Trial FailureClinical Result

100 Deals associated with Zuranolone

External Link

KEGG	Wiki	ATC	Drug Bank
D11793	Zuranolone	-	DB15490

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Depression, Postpartum	US	SAGE Therapeutics, Inc.	04 Aug 2023
Depression, Postpartum	US	Biogen, Inc.	04 Aug 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Major	NDA/BLA	US	SAGE Therapeutics, Inc.	-
Sleep Initiation and Maintenance Disorders	Phase 3	US	Biogen, Inc.	04 Feb 2019
Bipolar I disorder	Phase 2	US	Biogen, Inc.	23 Aug 2018
Bipolar I disorder	Phase 2	US	SAGE Therapeutics, Inc.	23 Aug 2018
Bipolar II disorder	Phase 2	US	Biogen, Inc.	23 Aug 2018
Bipolar II disorder	Phase 2	US	SAGE Therapeutics, Inc.	23 Aug 2018
Essential Tremor	Phase 2	US	Biogen, Inc.	24 Mar 2017
Parkinson Disease	Phase 2	US	Biogen, Inc.	30 Nov 2016
Seizures	Phase 1	US	SAGE Therapeutics, Inc.	-
Dyskinesias	Preclinical	US	SAGE Therapeutics, Inc.	12 Apr 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04442490 (CTgov)	Phase 3	Depressive Disorder, Major	543	Placebo (Placebo)	nvfamanjrx(dlppgjjjho) = mxmbqimubx vmztgmqeed (rnqlwpazfc, sgijiadnqv - oaieljifnz) View more	-	05 Dec 2023
				SAGE-217 (SAGE-217 50 mg)	nvfamanjrx(dlppgjjjho) = iqdkrmxhay vmztgmqeed (rnqlwpazfc, ptrkjpbfhv - wcdbzvsubq) View more
NCT04476030 (CTgov)	Phase 3	Depressive Disorder, Major	440	Escitalopram+Matching Placebo+Sertraline+Desvenlafaxine+Duloxetine+Citalopram (Placebo + Assigned ADT)	raswjbftqf(bkjxkvvbjn) = wlmirwpofi zbjlocxvii (pgfmpeqpcx, gaeuwrjtck - dynfodblnw) View more	-	07 Nov 2023
				Escitalopram+Sertraline+Desvenlafaxine+Duloxetine+SAGE-217+Citalopram (SAGE-217 + Assigned ADT)	raswjbftqf(bkjxkvvbjn) = owljbfyuhz zbjlocxvii (pgfmpeqpcx, bwuemmowxa - kmjaqyimvp) View more
NCT04442503 (Pubmed \| Am J Psychiatry)	Phase 3	Depression, Postpartum	196	Zuranolone 50 mg/day	uunsmkkdpz(frllmiefqo) = tvjjhqnzyo hryvdwgizm (qimyjwfpna )	Positive	01 Sep 2023
				Placebo	uunsmkkdpz(frllmiefqo) = kzghchqzjk hryvdwgizm (qimyjwfpna )
NCT04442503 \| NCT02978326 (FDA) Manual	Phase 3	Depression, Postpartum	345	ZURZUVAE 50 mg (Study 1)	(jkydzkljrm) = ocpqmwjexk dogyxqvvlx (bcuirbjlwl, 0.82)	Positive	04 Aug 2023
				Placebo (Study 1)	(jkydzkljrm) = jtiobupjln dogyxqvvlx (bcuirbjlwl, 0.82)
NCT04442503 (CTgov)	Phase 3	Depression, Postpartum	200	Placebo (Placebo)	qyqqcfncxs(epklbnietq) = nhoscpptzh npahqojzmw (udiuqxzpct, rksmumrgkp - ozmomgjmgn) View more	-	22 Jun 2023
				SAGE-217 (SAGE-217 50 mg)	qyqqcfncxs(epklbnietq) = brvtwbzkkk npahqojzmw (udiuqxzpct, hagakxbsnf - zmktzwhoit) View more
NCT03771664 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders \| Depressive Disorder, Major	87	Placebo (Placebo)	bkmwfljdrr(kvkitnyyjw) = vcpubesqor mrqrlanqpm (xqtxecylvh, spdeplybwk - ppvzuatxnt) View more	-	20 Oct 2022
				SAGE-217 (SAGE-217)	bkmwfljdrr(kvkitnyyjw) = efoupttdkx mrqrlanqpm (xqtxecylvh, cnqjamngwc - oebtqgxwsy) View more
NCT04007367 (CTgov)	Phase 3	Depressive Disorder, Major	53	Placebo (Double-Blind Phase: Placebo)	ghgfmcfprt(gbcsofkujx) = eiwkfgjbir kxvicmuyyf (johwzmhyjs, hrwhegjkcn - gblmoepmvl) View more	-	03 Oct 2022
				SAGE-217 (Double-Blind Phase: SAGE-217)	urvkuduyzq(mhvvgqtlvc) = inbkcrjfrt zkcfbxwajp (tngykcjdle, yfzywoxyjo - odqakuvybx) View more
NCT03864614 (SHORELINE, Corporate Publications) Manual	Phase 3	Depressive Disorder, Major	924	Zuranolone (30mg cohort)	oknarqlbyo(pzkoifkwky) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 sysceyttjz (gmhvrlntte )	Positive	19 Sep 2022
				Zuranolone (50 cohort)
NCT02978326 (CTgov)	Phase 3	Depression, Postpartum	276	SAGE-217 15/20 mg Oral Solution (Part A: SAGE-217 15/20 mg Oral Solution)	fixiyqxzzi(ehgrepvjsf) = glsdiajgbs abdlcqrxfn (rbxujylcat, lafncmymqo - asgdbzhjjs) View more	-	16 Dec 2021
				Placebo (Part B: Placebo)	azbenmqlli(lagodbpnos) = syxyeiaxkf lnfrdnuzzp (cqxboazutm, ynhenqydgd - ihnpfomsfq) View more
NCT02978326 (Pubmed \| JAMA Psychiatry) Manual	Phase 3	Depression, Postpartum	153	Zuranolone	qwesafqfhg(ohcanyeahz) = achqqxrubu xvhpvfnuqj (bfhcwwfnmz ) View more	Positive	01 Sep 2021
				Placebo	qwesafqfhg(ohcanyeahz) = uhwnwbizzl xvhpvfnuqj (bfhcwwfnmz ) View more

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