The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are:
* Is zuranolone safe to take by participants who have moderate to severe post-stroke depression?
* Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression?
* Does zuranolone treat moderate to severe post-stroke depression?
The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days.
Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.

Start Date14 Jan 2026

Sponsor / Collaborator

Duke University

[+1]

NCT07398469

/ RecruitingNot Applicable

A Longitudinal Online Survey of Patient-Reported Changes in Postpartum Depression Symptoms Following Zuranolone Use

In this study, researchers will learn how postpartum depression symptoms may change after people first start taking zuranolone. This is a drug available for doctors to prescribe for people with postpartum depression, also known as PPD. After giving birth, people with PPD can suffer from symptoms like tiredness, sadness, and a loss of interest in their daily activities.
This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will be found in the United States using a database from Accredo Specialty Pharmacy. This will include anyone who has a new prescription for zuranolone and were pregnant in the last 12 months before joining the study.
The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be done using a questionnaire called the Edinburgh Postnatal Depression Scale, also known as the EPDS.
The main question that researchers want to answer is:
• Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15?
Researchers will also learn about :
* Changes in participants' EPDS scores at Day 45 and Day 90 in the study
* Changes in EPDS scores at Day 15, Day 45, and Day 90 in a group of participants who have moderately severe PPD before starting zuranolone
* How many participants breastfeed their babies while taking zuranolone
* How many participants report not starting new medicine after finishing their zuranolone treatment
The study will be done as follows:
* People with PPD who get a new zuranolone prescription through Accredo Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study.
* Before taking their first dose of zuranolone, participants will be asked to answer written questions about their symptoms using the online EPDS survey. They will also answer other survey questions about their background, environment, and general health information. Participants must take their first dose of zuranolone within 7 days of joining the study.
* Participants will then be asked to answer questions using the EPDS survey, 15 days, 45 days, and 90 days after taking the first dose of zuranolone. Each survey will take about 10-15 minutes to finish.

Start Date22 Dec 2025

Sponsor / Collaborator

Biogen, Inc.

NCT07047820

/ RecruitingNot Applicable

Prospective, Observational Survey Study Assessing Effectiveness of Zuranolone in Improving PPD Symptoms in the Real-world Setting

In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD. After giving birth, adults with PPD can suffer from symptoms such as tiredness, sadness, and a loss of interest in their daily activities.
This study is known as an observational study, which means it collects health information about study participants after a healthcare professional has already prescribed treatment. Participants for this study will be found in the United States using a database from CVS Specialty Pharmacy. This will include anyone who was prescribed zuranolone between June 2025 and May 2026 and who filled the prescription within 1 year after the end of their pregnancy.
The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be measured using a questionnaire completed by participants called the Edinburgh Postnatal Depression Scale, also known as the EPDS. A higher score on the EPDS may indicate more severe PPD symptoms.
The main question researchers want to answer in this study is:
- Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15?
Researchers will also learn more about:
* Changes in participants' EPDS scores from before treatment to Day 45, which is 30 days after treatment ends.
* How many participants breastfeed their babies while taking zuranolone
* How many participants do not start new medicine after finishing their zuranolone treatment
* How many participants take new medicines after finishing zuranolone
* How many participants already tried other medicines for their depression symptoms before joining this study
* How many participants take other medicines in general while taking zuranolone
This study will be done as follows:
People who fill their zuranolone prescription through CVS Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study.
Those who agree to take part will answer written questions about their symptoms using the EPDS tool. They will also answer other survey questions about their background, environment, and general health information. Participants must take their first dose of zuranolone within 7 days of joining the study.
Participants will then be asked to answer questions using the EPDS tools, 15 days and 45 days after taking the first dose of zuranolone.

Start Date30 Jun 2025

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Zuranolone

100 Translational Medicine associated with Zuranolone

100 Patents (Medical) associated with Zuranolone

134

Literatures (Medical) associated with Zuranolone

01 Feb 2026·Archives of Womens Mental Health

A systematic safety assessment of zuranolone: real-world adverse event analysis from the FAERS database

Article

Author: Yao, Kun ; Liu, Hua

OBJECTIVE:

This 2023study aims to evaluate the adverse reaction profile of Zuranolone through large-scale analysis of real-world data and to explore its underlying mechanisms, thereby providing complementary evidence for the safe clinical use of Zuranolone.

METHODS:

Reports associated with Zuranolone were extracted from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, covering the period from the third quarter (Q3) of 2023 to the first quarter (Q1) of 2025. Signal detection was performed using four distinct methods: the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian Confidence Propagation Neural Network (BCPNN), and the Empirical Bayesian Geometric Mean (EBGM).

RESULTS:

A total of 464 reports of adverse events (AEs) related to Zuranolone were included in this study. Signal detection analysis revealed that Zuranolone was most significantly associated with AEs in the System Organ Classes (SOCs) of nervous system disorders and psychiatric disorders. Among the frequently reported AEs, those related to central nervous system (CNS) depression were particularly prominent, including somnolence (135 cases), dizziness (101 cases), sedation (35 cases), and tremor (32 cases). The study also identified common psychiatric AEs, including known events such as anxiety, suicidal ideation, depression, insomnia, depressed mood, and perinatal depression, as well as new potential AEs including panic attack, anger, bradyphrenia, intrusive thoughts, tachyphrenia, and decreased interest.

CONCLUSION:

Enhanced monitoring for AEs related to nervous system disorders and psychiatric disorders is required during the clinical use of Zuranolone.

01 Jan 2026·JOURNAL OF AFFECTIVE DISORDERS

Modeling the efficacy of a novel antidepressant zuranolone for major depressive disorder

Article

Author: Qian, Yudie ; Liu, Jianmin ; Lin, Weiwei ; Chen, Rui ; Hong, Limian

This research aimed to quantify the treatment potential of zuranolone-a novel positive allosteric GABA_A receptor modulator-in adults with major depressive disorder (MDD). Publicly available databases were systematically searched to identify randomized, placebo-controlled trials. We used changes in rating scale scores from baseline to perform a model-based meta-analysis, characterizing the progression of drug efficacy and placebo response over time and comparing zuranolone's efficacy and safety profiles with those of established antidepressants (escitalopram and amitriptyline). Pharmacokinetic modeling and meta-analysis frameworks were applied to assess efficacy and placebo response characteristics. A total of 37 trials (N = 8735 individuals) were incorporated in the final analysis. Zuranolone exhibited a rapid onset of action (k = 0.75 day^-1), 10-fold and 27.8-fold faster than amitriptyline (k = 0.075 day^-1) and escitalopram (k = 0.027 day^-1), respectively. Amitriptyline exhibited the highest pure efficacy, continuously increasing over time. The 95 % confidence intervals (CIs) of zuranolone and escitalopram overlapped, suggesting similar efficacy. Zuranolone achieved significant symptom improvement within two weeks of treatment (-6.64 %, 95 % CI: -9.77 % to -3.39 %) and sustained efficacy through four weeks post-treatment. The dropout rate was lower with zuranolone (2.4 %, 95 % CI: 1.5 to 3.3 %) than with escitalopram (4.5 %, 95 % CI: 3.0 to 5.9 %). Primary adverse events related to zuranolone included somnolence, headache, dizziness, and sedation, with no severe safety signals observed. Zuranolone demonstrates a safety profile comparable to escitalopram as well as rapid-onset antidepressant action, sustained clinical efficacy, and favorable tolerability, highlighting its potential as a promising therapeutic option for MDD.

01 Jan 2026·JOURNAL OF AFFECTIVE DISORDERS

Real-world safety profile of zuranolone for postpartum depression: A FAERS analysis

Article

Author: Pan, Weiping ; Yan, Shaowei ; Chen, Lingbin ; Chen, Zhou ; Xu, Yuying

OBJECTIVE:

Zuranolone, the first oral medication specifically designed to treat postpartum depression (PPD), was approved by the FDA in August 2023. However, reports on post-marketing adverse drug reactions (ADRs) related to it remain relatively limited. Therefore, this study aims to identify disproportional ADRs signals associated with zuranolone.

METHODS:

We extracted FAERS data from Q3 2023 to Q1 2025 and performed signal detection for zuranolone using both the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method. Clinical prioritization of safety signals was performed on Preferred Terms (PTs) not listed in the product labeling. Conduct sensitivity analyses on subgroups of perinatal depression.

RESULTS:

We identified 477 unique cases using zuranolone. Statistical disproportionality analysis detected positive signals for zuranolone predominantly in Nervous system disorders and Psychiatric disorders. Among adverse reactions (AEs) not listed in zuranolone's prescribing information, feeling drunk demonstrated the strongest positive signal, followed by bradyphrenia, intrusive thoughts, tachyphrenia, and hangover. It is worth noting that one death case due to suicide was reported in this analysis, which was submitted by a physician. Sensitivity analyses confirmed most positive signals aligned with initial findings (top 30 PTs).

CONCLUSION:

Our pharmacovigilance study identified a high reporting frequency of psychiatric and neurological ADRs associated with zuranolone use. Given the inherent limitations in establishing causality through FAERS data, we emphasize the need for future clinical monitoring and research to further substantiate the potential causal relationship between zuranolone and these reported AEs.

258

News (Medical) associated with Zuranolone

06 Feb 2026

·firstwordpharma.com

Vumerity bucks the MS trend as Biogen provides upbeat profit forecast

Biogen's profit forecast for the current year topped analyst estimates, even as the company guided for a mid-single digit decline in sales due to continued pressure on the majority of its multiple sclerosis products. Biogen — whose shares rose more than 4% on Friday — expects earnings per share in 2026 of between $15.25 and $16.25, above analyst predictions of $14.92 per share.Revenue from MS products fell 7% last year to $4 billion, with Biogen's outlook expecting the decline to accelerate into the mid-teen percentages for 2026. However, sales of Vumerity are set to be an outlier amongst the company's MS portfolio."We've tended to just look at MS as one group. But actually when you look at the oral segment, Vumerity is about the only branded medicine left," said CEO Christopher Viehbacher. "We have found that actually…with intelligent investments, we've been able to grow that brand very nicely. And so we're including that in our growth products going forward."Biogen also sees sales of biosimilars — dropping 8% last year to $729 million — continuing their downward trajectory, with estimates of a decline by a low double-digit percentage in 2026.Last year, Biogen's overall sales rose 2% to $9.9 billion, with Vumerity and other growth products — comprising Skyclarys, Qalsody, Zurzuvae, Spinraza and a 50% share of Leqembi — jumping 19% to $3.3 billion. Net income in 2025 was $1.3 billion, down from $1.6 billion in the prior year."Our 2025 performance reflected continued focus on strong execution and financial discipline, driven by our revenue of nearly $1 billion from Leqembi, Skyclarys, Zurzuvae and Qalsody, progression of our pipeline, and resilience of our MS franchise," said Viehbacher.Crucial Leqembi decisionBiogen reported Friday that sales of Alzheimer's therapy Leqembi — partnered with Eisai — rose 54% in the last three months of 2025 to $134 million, just ahead of analyst estimates of $129 million. The FDA approved a subcutaneous (SC) formulation of the anti–beta-amyloid antibody, dubbed Leqembi IQLIK, for maintenance dosing in August last year, while the agency is set to make a decision on its use as a starting dose by May 24.Viehbacher suggested that approval of Leqembi IQLIK for induction treatment could be a "game changer." He noted that while Eli Lilly's similar therapy Kisunla has once-monthly infusions, Leqembi is given once every two weeks. "Once you move to a subcutaneous injection, now we're not talking about infusions at all anymore."

Drug ApprovalBiosimilar

06 Feb 2026

·www.biospace.com

Biogen’s ‘Bridge To Growth’ Cuts Through a Stacked Phase 3 Pipeline

iStock, wildpixel With Biogen’s multiple sclerosis portfolio facing more generic pressure than ever, the company is eyeing a busy late-stage pipeline and hunting for deals to build its return to growth. Biogen is not growing right now, but the company has established a “bridge to growth,” with an emphasis on a slew of Phase 3 readouts to come in the next few years and a careful hunt for acquisitions. “To really return to growth, I think there’s two things that really need to happen. One is we do need to start seeing the positive Phase 3 results come out and the launch of products,” CEO Chris Viehbacher said on the company’s fourth quarter earnings call on Friday. “The other of course, is [business development], and we continue to look for potential acquisition opportunities.” On the first point, Biogen is currently running 10 Phase III trials, which could one day turn into approved products. Viehbacher in particular pointed to litifilimab, which is due for mid- and late-stage readouts in two types of lupus this year. The first, a Phase 2 test for cutaneous lupus erythematosus, is expected around the end of the first quarter and the second, the late-phase systemic lupus erythematosus trial, will arrive in the fourth quarter. That product could launch in 2028, the CEO predicted. On business development, Biogen is conducting a careful search for companies in the $5 billion to $6 billion range in the post-Phase 3 results stage—a goal that has not changed in recent quarters. “The reality is that it’s hard to find things that actually generate value for our shareholders,” Viehbacher explained. “There are certainly companies out there, but we haven’t found one that we can acquire for a price that we think makes sense for our shareholders. But we continue to look. We are looking every day out there in the marketplace.” So, for now, the existing late-stage pipeline is Biogen’s future. “We have some pretty high conviction in our late-stage pipeline. Now, nothing is ever given in research and development, as we all know,” Viehbacher said. “But you know, 10 Phase 3 programs, that’s a real achievement from over the past year.” At the end of 2024, the company only had litifilimab in that advanced a stage. Since then, they have added zorevunersen for Dravet syndrome, with a Phase III read out expected in mid-year 2027, and felzartamab for antibody-mediated rejection, which will also offer late-stage data in mid-2027. “I think we’ve been able to really, again, create that bridge to growth. We’re generating cash, we’re generating profits, and we’re investing significantly in our growth brands,” Viehbacher said. Under Pressure The decline of growth comes as Biogen’s multiple sclerosis portfolio faces generic pressure around the world. This segment showed some “resilience,” according to CFO Robin Kramer, with $9.9 billion in revenue generated in 2025—a 2% increase over the year prior. Generic erosion began for Tecfidera in 2025, and in 2026 the product will face the full weight of that pressure in Europe. A biosimilar of Tysabri entered the market at the end of the year as well, Viehbacher noted. The CEO is confident that Biogen can maintain the brand for a little while longer despite this new entrant. “There’s a limited number of physicians who are very strong believers in the importance of Tysabri so that’s what we’re going to rely on,” Viehbacher said. The growth products, including Alzheimer’s disease therapy Leqembi and post-partum depression drug Zurzuvae, did bring in $3.3 billion for 2025, a 19% increase over the previous year. This helped offset the declining MS portfolio. Leqembi, which has been a slow and steady launch for Biogen, showed some strength in the fourth quarter with sales of $134 million, a 54% increase year-over-year.

Phase 3Phase 2

04 Feb 2026

·www.pharmaceutical-technology.com

FDA grants breakthrough status to Biogen’s litifilimab for CLE

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Biogen’s litifilimab (BIIB059) for cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition. This designation aims to expedite the development and review of medicines for serious conditions. The FDA based its decision on comprehensive data, including findings from the Phase II LILAC study. Results from this trial indicated that litifilimab reduced skin disease activity in patients with CLE compared to placebo. Currently, treatment for CLE relies on antimalarials, immunosuppressants and topical steroids. While these therapies alleviate symptoms, they do not modify disease progression. The Phase III AMETHYST study is currently assessing litifilimab’s safety and efficacy, with results anticipated in 2027. Discovered and developed by Biogen scientists, litifilimab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody that targets blood dendritic cell antigen 2 (BDCA2). It is being investigated for both CLE and systemic lupus erythematosus (SLE). Litifilimab remains an investigational product pending regulatory approval, with efficacy and safety yet to be established. Biogen development executive vice-president and head Priya Singhal said: “The FDA grants breakthrough therapy designation to programmes based on the seriousness of the condition and the potential of the therapeutic candidate to provide substantial improvements over available therapies. “The FDA’s designation reinforces Biogen’s belief that litifilimab could be a first-in-class therapy targeting BDCA2 for cutaneous lupus erythematosus. This designation is a significant milestone for litifilimab as we advance the ongoing AMETHYST Phase III study, with the goal of bringing a new potential therapeutic option to the millions of people living with CLE.” In December 2025, Biogen received a notice of compliance (NOC) from Health Canada for Zurzuvae (zuranolone), a neuroactive steroid (NAS), as a treatment for moderate or severe postpartum depression (PPD) in women. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultBreakthrough TherapyPriority Review

100 Deals associated with Zuranolone

External Link

KEGG	Wiki	ATC	Drug Bank
D11793	Zuranolone	-	DB15490

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Depressive Disorder	Canada	Biogen, Inc.	01 Dec 2025
Depression, Postpartum	United States	SAGE Therapeutics, Inc.	04 Aug 2023
Depression, Postpartum	United States	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	United States	SAGE Therapeutics, Inc.	-
Sleep Initiation and Maintenance Disorders	Phase 3	United States	Biogen, Inc.	04 Feb 2019
Bipolar I disorder	Phase 2	United States	SAGE Therapeutics, Inc.	23 Aug 2018
Bipolar I disorder	Phase 2	United States	Biogen, Inc.	23 Aug 2018
Bipolar II disorder	Phase 2	United States	Biogen, Inc.	23 Aug 2018
Bipolar II disorder	Phase 2	United States	SAGE Therapeutics, Inc.	23 Aug 2018
Essential Tremor	Phase 2	United States	Biogen, Inc.	24 Mar 2017
Parkinson Disease	Phase 2	United States	Biogen, Inc.	30 Nov 2016
Seizures	Phase 1	United States	SAGE Therapeutics, Inc.	-
Dyskinesias	Preclinical	United States	SAGE Therapeutics, Inc.	12 Apr 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03864614 (SHORELINE Study, Pubmed \| J Clin Psychiatry)	Phase 3	Depressive Disorder, Major	-	Zuranolone 30mg	xrvrzazdjc(upjtbnealq) = Of patients who experienced TEAEs, most reported mild or moderately severe events, and responders to zuranolone experienced improvements in depressive symptoms with initial and repeat treatment courses foqejkhmhj (cazyhffgxx )	Positive	27 Dec 2023
				Zuranolone 50mg
NCT04442490 (CTgov)	Phase 3	Depressive Disorder, Major	543	Placebo (Placebo)	cvesoubyba(gsopkujxiu) = folsyasqpy cnuvaunwhc (qtilyeqhbq, 0.50) View more	-	05 Dec 2023
				SAGE-217 (SAGE-217 50 mg)	cvesoubyba(gsopkujxiu) = cvppgqewcx cnuvaunwhc (qtilyeqhbq, 0.51) View more
NCT04476030 (CTgov)	Phase 3	Depressive Disorder, Major	440	Escitalopram+Matching Placebo+Desvenlafaxine+sertraline+Duloxetine+Citalopram (Placebo + Assigned ADT)	kvbifusnkd(bnxcbehjcu) = dryknkcsfj glaopjfuyt (uihoqfymmc, 0.38) View more	-	07 Nov 2023
				Escitalopram+Desvenlafaxine+sertraline+Duloxetine+SAGE-217+Citalopram (SAGE-217 + Assigned ADT)	kvbifusnkd(bnxcbehjcu) = tgcdyufceb glaopjfuyt (uihoqfymmc, 0.39) View more
NCT04442503 (Pubmed \| Am J Psychiatry)	Phase 3	Depression, Postpartum	196	Zuranolone 50 mg/day	xbfwukkmze(qwytiagdch) = ltpginqapy krdkxfnqaj (okjtxnasje )	Positive	01 Sep 2023
				Placebo	xbfwukkmze(qwytiagdch) = mfnjehjktw krdkxfnqaj (okjtxnasje )
NCT04442503 \| NCT02978326 (FDA) Manual	Phase 3	Depression, Postpartum	345	ZURZUVAE 50 mg (Study 1)	vwfwyrerkk(xlsmaaljkv) = xijtbhovqp wtdxfjvguu (mwnrupzydh, 0.82)	Positive	04 Aug 2023
				Placebo (Study 1)	vwfwyrerkk(xlsmaaljkv) = flcjrntcqj wtdxfjvguu (mwnrupzydh, 0.82)
NCT04442503 (CTgov)	Phase 3	Depression, Postpartum	200	Placebo (Placebo)	rjsteqbabv(limgxoxcom) = rmgdzagqiv zpbgyqzvyn (wquaumrbzo, 2.34) View more	-	22 Jun 2023
				SAGE-217 (SAGE-217 50 mg)	rjsteqbabv(limgxoxcom) = dczugauesa zpbgyqzvyn (wquaumrbzo, 2.49) View more
NCT03771664 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders \| Depressive Disorder, Major	87	Placebo (Placebo)	reuhamtlrv(mmmbcnyflo) = ydqmjxryfd btxhbwwygg (lehpgnebmq, 14.9367) View more	-	20 Oct 2022
				SAGE-217 (SAGE-217)	reuhamtlrv(mmmbcnyflo) = vsfcvhjjau btxhbwwygg (lehpgnebmq, 9.8100) View more
NCT04007367 (CTgov)	Phase 3	Depressive Disorder, Major	53	Placebo (Double-Blind Phase: Placebo)	xoiakhbsfm(gbdyfkhsva) = gfysoadlpm mcxwzmoqtl (bxhyovsqay, jbenxfdxtq - uukzstxnms) View more	-	03 Oct 2022
				SAGE-217 (Double-Blind Phase: SAGE-217)	gvvfiuogpc = apaoinyiuj fullpdnrld (dxbxuhqejm, ovhkxzpeqd - wxjlxvhplc) View more
NCT03864614 (SHORELINE, Corporate Publications) Manual	Phase 3	Depressive Disorder, Major	924	Zuranolone (30mg cohort)	qsmqoqlciv(nyicrewcci) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 ppvbqzuvjb (ogfmixlmoq )	Positive	19 Sep 2022
				Zuranolone (50 cohort)
NCT03692910 (CTgov)	Phase 2	Bipolar II disorder \| Bipolar I disorder \| Depressive Disorder, Major	35	SAGE-217	cgugeoalxr = dhtkjnakvj qeytqqivmg (evqlqeldhq, rjiweddvna - alofaxovph) View more	-	20 Apr 2022

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