A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in Major Depressive Disorder (TERPSIS STUDY)

To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).

Start Date30 Nov 2021

Sponsor / Collaborator

Neurocrine Biosciences, Inc.

NCT03319953 / CompletedPhase 2

A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Subjects With Stable Schizophrenia

The purpose of the study is to determine whether motivation/reward deficits observed in schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia is improved by add-on TAK-041 administration to antipsychotics in participants with stable schizophrenia.

Start Date21 Dec 2017

Sponsor / Collaborator

Neurocrine Biosciences, Inc.

[+1]

NCT02959892 / CompletedPhase 1

A Phase 1, Open-Label, Positron Emission Tomography Study in Healthy Subjects to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the CNS After Single-Dose Oral Administration

The purpose of this study is to determine brain penetration of single oral doses of TAK-041 and its effects on amphetamine-induced dopamine release in the Central Nervous System (CNS).

Start Date05 Dec 2016

Sponsor / Collaborator

Neurocrine Biosciences, Inc.

[+1]

100 Clinical Results associated with Zelatriazin

100 Translational Medicine associated with Zelatriazin

100 Patents (Medical) associated with Zelatriazin

Literatures (Medical) associated with Zelatriazin

26 Oct 2023·Journal of medicinal chemistryQ1 · MEDICINE

Design and Synthesis of Novel GPR139 Agonists with Therapeutic Effects in Mouse Models of Social Interaction and Cognitive Impairment.

Q1 · MEDICINE

Article

Author: Duan, Wenwen ; Zhou, Ning ; Mao, Jianhang ; Liu, Zhi-Jie ; Cheng, Jianjun ; Wang, Huan ; Cui, Yilong ; Hua, Tian

The GPR139 receptor is an orphan G-protein-coupled receptor (GPCR) mainly found in the central nervous system and is a potential therapeutic target for the treatment of schizophrenia and drug addiction. Guided by the reported structure of GPR139, we conducted medicinal chemistry optimizations of TAK-041, the GPR139 agonist in clinical trials. New compounds with three different core structures were designed and synthesized, and their activity at GPR139 was evaluated. Among them, compounds 15a (EC₅₀ = 31.4 nM) and 20a (EC₅₀ = 24.7 nM) showed potent agonist activity at GPR139 and good pharmacokinetic properties. In murine schizophrenia models, both compounds rescued the social interaction deficits observed in BALB/c mice. Compound 20a also alleviated cognitive deficits in mice with a pharmacologically induced model of schizophrenia. These findings further demonstrated the potential of GPR139 agonists in alleviating the negative symptoms and cognitive deficits of schizophrenia. Compound 20a is worth further evaluation as an antischizophrenia drug candidate.

01 Aug 2022·NeuropharmacologyQ2 · MEDICINE

Effects of GPR139 agonism on effort expenditure for food reward in rodent models: Evidence for pro-motivational actions

Q2 · MEDICINE

Article

Author: Bretschneider, Tom ; Koros, Eliza ; Sommer, Susanne ; Ferger, Boris ; Deiana, Serena ; Münster, Alexandra ; Sigrist, Hannes ; Hauber, Wolfgang ; Mayer-Wrangowski, Svenja ; von Heimendahl, Moritz ; Pryce, Christopher R ; Baader-Pagler, Tamara ; Klinder, Klaus ; Kúkeľová, Diana

Apathy, deficiency of motivation including willingness to exert effort for reward, is a common symptom in many psychiatric and neurological disorders, including depression and schizophrenia. Despite improved understanding of the neurocircuitry and neurochemistry underlying normal and deficient motivation, there is still no approved pharmacological treatment for such a deficiency. GPR139 is an orphan G protein-coupled receptor expressed in brain regions which contribute to the neural circuitry that controls motivation including effortful responding for reward, typically sweet gustatory reward. The GPR139 agonist TAK-041 is currently under development for treatment of negative symptoms in schizophrenia which include apathy. To date, however, there are no published preclinical data regarding its potential effect on reward motivation or deficiencies thereof. Here we report in vitro evidence confirming that TAK-041 increases intracellular Ca²⁺ mobilization and has high selectivity for GPR139. In vivo, TAK-041 was brain penetrant and showed a favorable pharmacokinetic profile. It was without effect on extracellular dopamine concentration in the nucleus accumbens. In addition, TAK-041 did not alter the effort exerted to obtain sweet gustatory reward in rats that were moderately food deprived. By contrast, TAK-041 increased the effort exerted to obtain sweet gustatory reward in mice that were only minimally food deprived; furthermore, this effect of TAK-041 occurred both in control mice and in mice in which deficient effortful responding was induced by chronic social stress. Overall, this study provides preclinical evidence in support of GPR139 agonism as a molecular target mechanism for treatment of apathy.

01 Jun 2022·NeuropsychopharmacologyQ1 · MEDICINE

Endogenous dopamine release in the human brain as a pharmacodynamic biomarker: evaluation of the new GPR139 agonist TAK-041 with [11C]PHNO PET

Q1 · MEDICINE

Article

Author: Gunn, Roger N ; Schwarz, Adam J ; Searle, Graham E ; Yin, Wei ; Passchier, Jan ; Tauscher, Johannes ; Dennison, Jeremy M T J ; Uz, Tolga ; Rabiner, Eugenii A ; Atienza, Joy ; Lewis, Yvonne ; Wu, Jingtao ; Chen, Grace ; Mansur, Ayla ; Brown, Terry

AbstractThe use of positron emission tomography (PET) in early-phase development of novel drugs targeting the central nervous system, is well established for the evaluation of brain penetration and target engagement. However, when novel targets are involved a suitable PET ligand is not always available. We demonstrate an alternative approach that evaluates the attenuation of amphetamine-induced synaptic dopamine release by a novel agonist of the orphan G-protein-coupled receptor GPR139 (TAK-041). GPR139 agonism is a novel candidate mechanism for the treatment of schizophrenia and other disorders associated with social and cognitive dysfunction. Ten healthy volunteers underwent [11C]PHNO PET at baseline, and twice after receiving an oral dose of d-amphetamine (0.5 mg/kg). One of the post-d-amphetamine scans for each subject was preceded by a single oral dose of TAK-041 (20 mg in five; 40 mg in the other five participants). D-amphetamine induced a significant decrease in [11C]PHNO binding potential relative to the non-displaceable component (BPND) in all regions examined (16–28%), consistent with increased synaptic dopamine release. Pre-treatment with TAK-041 significantly attenuated the d-amphetamine-induced reduction in BPND in the a priori defined regions (putamen and ventral striatum: 26% and 18%, respectively). The reduction in BPND was generally higher after the 40 mg than the 20 mg TAK-041 dose, with the difference between doses reaching statistical significance in the putamen. Our findings suggest that TAK-041 enters the human brain and interacts with GPR139 to affect endogenous dopamine release. [11C]PHNO PET is a practical method to detect the effects of novel drugs on the brain dopaminergic system in healthy volunteers, in the early stages of drug development.

News (Medical) associated with Zelatriazin

30 Oct 2024

·www.prnewswire.com

Neurocrine Biosciences Reports Third Quarter 2024 Financial Results and Raises 2024 INGREZZA Sales Guidance

INGREZZA® (valbenazine) Third Quarter Net Product Sales of $613 Million Representing 26% Year-Over-Year Growth INGREZZA ® (valbenazine) 2024 Net Product Sales Guidance Raised to $2.30 - $2.32 Billion Board Authorizes $300 Million Share Repurchase Plan SAN DIEGO, Oct. 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the third quarter ended September 30, 2024 and provided an update on its 2024 financial guidance. "With continued INGREZZA growth across the tardive dyskinesia and Huntington's disease chorea indications, FDA Priority Review for crinecerfont in congenital adrenal hyperplasia, a deep neuroscience focused pipeline and a strong balance sheet, we are confident in our ability to help more patients than ever before," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences. William Rastetter, Chairman of the Board of Directors of Neurocrine Biosciences, said, "The share repurchase authorization reflects the Board's confidence in Neurocrine's significant value creation potential. Importantly, the new share repurchase authorization preserves our flexibility to drive sustained growth through investments in INGREZZA and the anticipated launch of crinecerfont, while also advancing our diverse pipeline and maintaining our strong balance sheet." Financial Highlights INGREZZA Net Product Sales Highlights INGREZZA third quarter 2024 net product sales were $613 million and grew 26% compared to the third quarter 2023 Year-over-year growth driven by strong underlying patient demand and improvement in gross-to-net dynamics Other Key Financial Highlights Differences in third quarter 2024 GAAP and Non-GAAP operating expenses compared with third quarter 2023 were driven by: Increased R&D expense in support of an expanded and advancing portfolio including investments in muscarinic compounds, gene therapy programs, and second generation VMAT2 inhibitors. Third quarter 2024 R&D expense includes $39 million for development milestones achieved under collaborations with Nxera Pharma UK Limited (Nxera, formerly known as Sosei Heptares) and Voyager Therapeutics, Inc. (Voyager). Increased SG&A expense includes incremental investment in crinecerfont-related headcount, crinecerfont-related pre-launch activities, and continued investment in INGREZZA, including the recent expansion of our psychiatry and long-term care sales teams in September 2024. Third quarter 2024 GAAP net income and earnings per share were $130 million and $1.24, respectively, compared with $83 million and $0.82, respectively, for third quarter 2023 Third quarter 2024 Non-GAAP net income and earnings per share were $189 million and $1.81, respectively, compared with $156 million and $1.54, respectively, for third quarter 2023 Differences in third quarter 2024 GAAP and Non-GAAP net income compared with third quarter 2023 driven by: Higher INGREZZA net sales and improved operating margin Third quarter 2024 includes $17 million loss from changes in fair values of equity investments compared with $40 million loss for third quarter 2023 (Non-GAAP adjustment) Third quarter 2024 includes $39 million of expense for development milestones achieved under collaborations with Nxera and Voyager At September 30, 2024, the Company had cash, cash equivalents and marketable securities totaling approximately $1.9 billion A reconciliation of GAAP to Non-GAAP financial results can be found in Table 3 and Table 4 at the end of this news release. Recent Developments Kyle W. Gano, Ph.D. appointed Chief Executive Officer effective October 11, 2024. Announced the Company's Board of Directors has authorized a $300 million share repurchase plan. The Company subsequently intends to enter into a $300 million accelerated share repurchase transaction in the coming days, subject to market conditions, which will constitute the entirety of the authorized share repurchase plan. Announced positive topline data for the Phase 2 study of NBI-1117568, a first-in-class, orally active, highly selective investigational M4 agonist, in development as a potential treatment for schizophrenia. The successful completion of the Phase 2 study triggered a $35 million milestone payment to Nxera in the third quarter of 2024. We expect to advance NBI-1117568 into Phase 3 development in the first half of 2025, which would trigger an additional $15 million milestone payment to Nxera upon initiation of the Phase 3 study. Presented KINECT ®-HD2 interim data at the 2024 MDS International Congress of Parkinson's Disease and Movement Disorders demonstrating robust and sustained improvements in chorea associated with Huntington's Disease through week 104 irrespective of antipsychotic use. Announced the ERUDITE™ Phase 2 study of luvadaxistat (NBI-1065844) in cognitive impairment associated with schizophrenia (CIAS) did not meet its primary endpoint. In addition, we provided Takeda Pharmaceutical Company Limited with written notice of termination of the license agreement to develop and commercialize luvadaxistat and NBI-1065846. The termination is anticipated to be effective in April 2025. Provided Idorsia Pharmaceuticals Ltd. with written notice of termination of the license agreement to develop and commercialize NBI-827104 in epileptic encephalopathy with continuous spike and wave during sleep. The termination is anticipated to be effective in January 2025. Raised 2024 Net Sales Guidance and Updated Expense Guidance Conference Call and Webcast Today at 8:00 AM Eastern Time Neurocrine Biosciences will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can access the live conference call by dialing 800-225-9448 (US) or 203-518-9708 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 8:00 a.m. Eastern Time on Neurocrine Biosciences' website under Investors at . A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. About Neurocrine Biosciences Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie) NEUROCRINE BIOSCIENCES, NEUROCRINE and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences, Inc. Non-GAAP Financial Measures In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following Non-GAAP financial measures: Non-GAAP R&D expense, Non-GAAP SG&A expense, and Non-GAAP net income and net income per share. When preparing the Non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these Non-GAAP financial measures exclude: non-cash stock-based compensation expense, charges associated with convertible senior notes, vacated legacy campus facility costs, net of sublease income, non-cash amortization expense related to acquired intangible assets, acquisition and integration costs, changes in fair value of equity security investments, changes in foreign currency exchange rates and certain adjustments to income tax expense. These Non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these Non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these Non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined R&D and SG&A expenses on both a GAAP and a Non-GAAP basis. A reconciliation of these GAAP financial results to Non-GAAP financial results is included in the attached financial information. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our financial and operating performance, including our future revenues, expenses, or profits; our collaborative partnerships; expected future clinical and regulatory milestones; the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners; and our intention to enter into an accelerated share repurchase transaction, including the expected dollar amounts and the timing of the transaction. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks and uncertainties associated with the commercialization of INGREZZA; risks that the crinecerfont New Drug Applications (NDAs) may not obtain regulatory approval, such approval may be delayed, or may not receive the benefits associated with priority review; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; constraints, volatility, or disruptions in the capital markets or other factors affecting our ability to enter into or complete an accelerated share repurchase transaction; and other risks described in our periodic reports filed with the SEC, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law. SOURCE Neurocrine Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2License out/inFinancial StatementExecutive Change

24 Apr 2024

·www.biospace.com

Neurocrine’s Takeda-Partnered Drug Candidate Aces Phase II Depression Study

Pictured: Man sitting on the floor with his head in his hands/iStock, gorodenkoff Neurocrine Biosciences on Tuesday released topline data from the Phase II SAVITRI study showing that its investigational drug NBI-1065845, being developed in partnership with Takeda Pharmaceuticals, can significantly lower depression severity in adults with major depressive disorder. Results from SAVITRI—which enrolled 183 patients who had previously shown inadequate responses to antidepressants—demonstrated that an undisclosed once-daily oral dose of NBI-1065845 could reduce the Montgomery Åsberg Depression Rating Scale (MADRS) total score by 4.3 points versus placebo at 28 days. This effect was statistically significant, with a p-value of 0.0159, according Neurocrine. In major depressive disorder (MDD), the MADRS is used to quantify the severity of depressive episodes. At day 58, NBI-1065845’s effect improved resulting in a 7.5-point drop in the total MADRS score relative to placebo. A second undisclosed dose also “demonstrated a trend toward improvement over placebo,” though these effects failed to cross the threshold for statistical significance both at day 28 and 56. In terms of safety, NBI-1065845 was also generally well-tolerated. Its most common side effect was headache and its overall adverse event pro comparable to that of placebo. SAVITRI recorded no deaths or serious adverse events, while its dropout rates were low. Neurocrine CMO Eiry Roberts called these topline findings “very encouraging” in a statement. “Many millions of people living with major depressive disorder do not fully benefit from currently available treatments and experience persistent debilitating symptoms,” Roberts added, noting that “NBI-1065845 has the potential to be a first-in-class treatment” for these symptoms. Originally developed by Takeda, NBI-1065845 is an investigational positive allosteric modulator of the alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) receptor. In June 2020, Neurocrine paid $120 million upfront and pledged up to $495 in development milestones for the license to develop and commercialize seven psychiatry programs, three of which are clinical-stage including NBI-1065845. Under the terms of the agreement, Neurocrine would be responsible for developing and commercializing all candidates covered by the deal. Takeda will also be entitled to up to $1.4 billion in commercial milestones, plus up to double-digit royalties on net sales. In November 2023, Neurocrine discontinued the development of one of the Takeda programs—dubbed NBI-1065846—after it failed to demonstrate a significant improvement in anhedonia in the Phase II TERPSIS study in patients with MDD. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Phase 2License out/inClinical ResultClinical Trial Failure

23 Apr 2024

·www.prnewswire.com

Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1065845 in Adults with Major Depressive Disorder

SAVITRI™ Study Met Primary Endpoint with Statistically Significant Reduction in Montgomery Åsberg Depression Rating Scale ( MADRS) Total Score at Day 28 Met Key Secondary Endpoints, Including Statistically Significant Reduction in MADRS Score at Day 56 NBI-1065845 Was Generally Well-Tolerated SAN DIEGO, April 23, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced positive topline data for its Phase 2 SAVITRI™ study. This randomized, double-blind, placebo-controlled dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive disorder (MDD). NBI-1065845 is an investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) in development as a potential treatment for patients with MDD who have not benefited from treatment with at least one antidepressant in their current episode of depression. The study met its primary and key secondary endpoints, demonstrating that once-daily, oral administration of NBI-1065845 produced a statistically significant change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total score at both Day 28 (primary) and Day 56 (secondary). In the full analysis data set, the least squares (LS) mean differences from baseline in MADRS total score for NBI-1065845 were: One of the doses demonstrated an improvement over placebo of -4.3 (p-value = 0.0159) and -7.5 (p-value = 0.0016) at Day 28 and Day 56, respectively. The other dose also demonstrated a trend toward improvement over placebo of -3.0 (p-value = 0.0873) and -3.6 (p-value = 0.1082) at Day 28 and Day 56, respectively. NBI-1065845 was generally well tolerated. The most common adverse event was headache. The adverse event profile for both doses of NBI-1065845 were comparable to placebo. There were no deaths or serious adverse events. The discontinuation rates were low throughout the study. "Many millions of people living with major depressive disorder do not benefit fully from currently available treatments and experience persistent debilitating symptoms," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "NBI-1065845 has the potential to be a first-in-class treatment to alleviate many of these symptoms of MDD. The Phase 2 data from the SAVITRI study are very encouraging, and we look forward to meeting with the FDA to discuss a path into Phase 3 studies." Additional data from the SAVITRI study will be shared at a future scientific conference. About the Phase 2 SAVITRI™ Study The Phase 2 SAVITRI™ study is a double-blind, placebo-controlled study designed to assess the efficacy and safety of investigational NBI-1065845 in adult subjects with major depressive disorder (MDD). The study enrolled 183 adults with a primary diagnosis of MDD and who had inadequate response to current antidepressant treatment. About NBI-1065845 NBI-1065845 is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) in development as a potential treatment for patients with inadequate response to treatment in MDD. About the Collaboration with Takeda In 2020, Neurocrine Biosciences and Takeda (TSE:4502/NYSE:TAK) entered into a strategic collaboration to develop and commercialize compounds in Takeda's early-to-mid-stage psychiatry pipeline, including an exclusive license to NBI-1065845 (TAK-653). Under the terms of the agreement, Neurocrine Biosciences is responsible for developing and commercializing all compounds included in the collaboration and for compounds other than NBI-1065845 and NBI-1065846, Takeda is eligible to receive development or commercial milestone payments and royalties. For NBI-1065845 and NBI-1065846, Takeda may elect to opt out of a 50:50 profit share at certain development events on a program-by-program basis. Until such time Takeda elects to opt out of either profit share arrangement, it will not be eligible to receive development or commercial milestone payments. About Major Depressive Disorder Major depressive disorder (MDD) is a mental health disorder characterized by a persistently depressed mood, loss of interest, lack of enjoyment in daily activities, poor concentration, and decreased energy. MDD is one of the leading causes of disability. More than 21 million people in the U.S. live with major depressive disorder. It is estimated that roughly 1/3 of people living with major depressive disorder do not respond to available antidepressants. About Neurocrine Biosciences Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (formerly Twitter), and Facebook. (*in collaboration with AbbVie) NEUROCRINE BIOSCIENCES, NEUROCRINE, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo and SAVITRI are trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statement In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the clinical results from, and our future development plans with respect to, NBI-1065845, as well as the therapeutic potential and clinical benefits or safety profile of NBI-1065845. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements include: top-line data that we report may change following a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of the clinical study; risks that regulatory submissions for our products and/or product candidates may not occur or be submitted in a timely manner; our products and/or product candidates may not obtain regulatory approvals; or that the U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding our products and/or product candidates; our products and/or product candidates will not be found to be safe and/or effective or may not prove to be beneficial to patients; that development activities for our products and/or product candidates may not be completed on time or at all; that clinical development activities may be delayed for regulatory or other reasons, may not be successful or replicate previous and/or interim clinical trial results, or may not be predictive of real-world results or of results in subsequent clinical trials; competitive products and technological changes that may limit demand for our products; uncertainties relating to patent protection and intellectual property rights of third parties; our dependence on third parties for development and manufacturing activities related to our products and our product candidates, and our ability to manage these third parties; our future financial and operating performance; risks and uncertainties associated with the commercialization of our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2023. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof. SOURCE Neurocrine Biosciences, Inc.

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Major	Phase 2	US	Neurocrine Biosciences, Inc.	30 Nov 2021
Depressive Disorder, Major	Phase 2	PR	Neurocrine Biosciences, Inc.	30 Nov 2021
Anhedonia	Discovery	GB	Neurocrine Biosciences, Inc.	21 Dec 2017
Anhedonia	Discovery	GB	Takeda Pharmaceutical Co., Ltd.	21 Dec 2017
Schizophrenia	Discovery	GB	Takeda Pharmaceutical Co., Ltd.	01 Dec 2017
Cognition Disorders	Discovery	GB	Takeda Pharmaceutical Co., Ltd.	-
Cognition Disorders	Discovery	US	Takeda Pharmaceutical Co., Ltd.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05165394 (TERPSIS, CTgov)	Phase 2	Anhedonia \| Depressive Disorder, Major	93	Placebo	zwuifrunjv(xitfzoifdd) = siptqtfwwi nqwlhmwoax (wxyaparriv, yqqjrtacki - xavlutubyu) View more	-	31 Jul 2024
NCT02748694 (Pubmed) Manual	Phase 1	Schizophrenia	-	TAK-041	(czbcdcbcld) = mujywskbzo awtgmksnnn (ryiqzhycfm )	Positive	12 Mar 2022
NCT02959892 (CTgov)	Phase 1	-	12	[11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)+Amphetamine+TAK -041 (TAK-041 20 mg)	wxecbqoowt(pqijemqxlk) = tcqbzammva rwxifmoqcn (ngmvayydwp, agqfqrqhnn - bzqixcqoka) View more	-	23 Dec 2019
NCT02959892 (CTgov)	Phase 1	-	12	[11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)+Amphetamine+TAK -041 (TAK-041 40 mg)	wxecbqoowt(pqijemqxlk) = ubnulqnppq rwxifmoqcn (ngmvayydwp, whswtouogl - shbcbojiwc) View more	-	23 Dec 2019

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