Buspirone Hydrochloride

CTx-2103 has the Potential to be the First, Once-Daily Formulation of Buspirone, one of the Most Widely Prescribed Agents in the $5.5 Billion U.S. Anxiety Market, and the $11.6 Billion Anxiety Market Worldwide Non-Dilutive Funding Expands Pipeline and Further Validates Cingulate’s Proprietary Precision Timed Release™ Drug Delivery Technology CTx-2103 has the Potential to Reduce Use of Benzodiazepine’s and Associated Withdrawal and Dependency Issues KANSAS CITY, Kan., April 09, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it has received a $3 million grant to accelerate the development of CTx-2103 (buspirone) for the treatment of anxiety. CTx-2103 has the potential to be the first, once-daily formulation of buspirone, one of the most widely prescribed agents in the $5.5 billion U.S. anxiety market ($11.6 billion global). The grant will be made in three tranches of $1 million each, the first tranche to be paid on May 1st , and the two subsequent tranches payable based on specified product development milestones. The foundation will receive a future royalty contingent on the commercialization of CTx-2103, beginning six months after the after the first commercial sale of CTx-2103, payable at $500,000 per quarter, with a maximum cumulative royalty of $3.5 million. “This grant was made by a private foundation whose foremost interest is combating the global rise of critical health issues such as anxiety in a consequential way. We thank the foundation for this funding for the development of CTx-2103, which advances Cingulate’s pipeline and illustrates the applicability of our PTR™ platform. Today, we are one step closer to providing the first, once-daily medicine for the millions of patients worldwide who suffer from anxiety-related disorders, the most common mental health issue in America and around the world,” said Cingulate Chairman and CEO Shane J. Schaffer. According to the National Institutes of Mental Health (NIMH), anxiety disorders are the most common mental health concern in the U.S. An estimated 31 percent of U.S. adults experience an anxiety disorder at some time in their lives. People may live with anxiety for years before they are diagnosed or treated. 1 About CTx-2103 CTx-2103 is a novel, multi-release tablet of buspirone that incorporates Cingulate’s proprietary PTR™ drug delivery platform. CTx-2103 is being studied for the treatment of anxiety and/or anxiety-related disorders. Buspirone, an azapirone derivative and a 5-HT1A partial agonist, was the first non-benzodiazepine anxiolytic introduced for the treatment of generalized anxiety disorder. Buspirone may exhibit a decreased side-effect profile compared to other anxiolytic treatments. Unlike benzodiazepines and barbiturates, there is no associated risk of physical dependence or withdrawal with buspirone use due to the lack of effects on gamma-aminobutyric acid receptors. About Anxiety Anxiety disorders are the most common mental health concern in the U.S.1 Anxiety is the feeling of fear that occurs when faced with threatening or stressful situations or can be endogenous and not have an identified stressor. It can be a normal response when confronted with danger, but, if severe and chronic and affects functioning, it could be regarded as an anxiety disorder. An estimated 31 percent of U.S. adults experience an anxiety disorder at some time in their lives. People may live with anxiety for years before they are diagnosed or treated. The global COVID-19 crisis has exacerbated the diagnosis and treatment of anxiety and anxiety related disorders and as a result is a priority within the class of unmet medical needs in mental health.1 About Precision Timed Release™ (PTR™) Platform Technology Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here. About Cingulate Inc. Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our other filings with the SEC. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. Investor & Public Relations: Thomas Dalton Vice President, Investor & Public Relations, Cingulate tdalton@cingulate.com (913) 942-2301 Matt Kreps Darrow Associates mkreps@darrowir.com (214) 597-8200

本周药品注册受理数据，分门别类呈现，一目了然。(3.24-3.30）新药上市申请药品名称企业注册分类受理号布瑞哌唑口溶膜南通慧聚制药有限公司2.2CXHS2500026布瑞哌唑口溶膜南通慧聚制药有限公司2.2CXHS2500025新药临床申请药品名称企业注册分类受理号DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500342DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500341DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500340AOD113408注射液成都奥达生物科技有限公司1CXHL2500339EDP167注射液亿腾医药(珠海)有限公司1CXHL2500336VVN432鼻喷雾剂维眸生物科技(浙江)有限公司1CXHL2500335VVN432鼻喷雾剂维眸生物科技(浙江)有限公司1CXHL2500334CPI-818片嘉兴和剂药业有限公司1CXHL2500332CPI-818片嘉兴和剂药业有限公司1CXHL2500331WJ47156片上海君实生物医药科技股份有限公司1CXHL2500330WJ47156片上海君实生物医药科技股份有限公司1CXHL2500329JKN2301干混悬剂健康元药业集团股份有限公司1CXHL2500327BW-40202注射液上海舶望制药有限公司1CXHL2500338RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500325RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500324RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500323WSD0922-FU片杭州威瑞宝生物医药有限公司1CXHL2500322WSD0922-FU 片杭州威瑞宝生物医药有限公司1CXHL2500321JZ-14胶囊云白药征武科技(上海)有限公司1CXHL2500320JZ-14胶囊云白药征武科技(上海)有限公司1CXHL2500319SVHRSP注射液沈阳万锦医药科技有限公司1CXHL2500318Alpha-0261片深圳阿尔法分子科技有限责任公司1CXHL2500316Alpha-0261片深圳阿尔法分子科技有限责任公司1CXHL2500315AKZ002直服颗粒海南爱科制药有限公司2.2CXHL2500343WS-011湖北午时药业股份有限公司2.2CXHL2500337ZL-0018山东则正医药技术有限公司2.2CXHL2500328硫酸镁无菌溶液广东迈恒医药研发有限公司2.2CXHL2500326EP-0203XR成都苑东生物制药股份有限公司2.3CXHL2500333注射用甲苯磺酸瑞马唑仑江苏恒瑞医药股份有限公司2.4CXHL2500317注射用JS207上海君实生物医药科技股份有限公司1CXSL2500252HD006细胞华道(上海)生物医药有限公司1CXSL2500251Cizutamig注射液上海坦蒂生物医药科技有限公司1CXSL2500249注射用人白介素-2(高亲和型复合物)北京良远生物医药研究有限公司1CXSL2500248注射用SSGJ-705沈阳三生制药有限责任公司1CXSL2500247注射用BC2027无锡智康弘义生物科技有限公司1CXSL2500245注射用TQB2102正大天晴药业集团南京顺欣制药有限公司1CXSL2500241AZD0901阿斯利康全球研发(中国)有限公司1CXSL2500242注射用MK-2870默沙东研发(中国)有限公司2.2CXSL2500244注射用重组A型肉毒毒素北京博特维克生物技术有限公司2.4CXSL2500246仿制药申请药品名称企业注册分类受理号马来酸曲美布汀片浙江东亚药业股份有限公司3CYHS2501232马来酸曲美布汀片浙江东亚药业股份有限公司3CYHS2501231厄贝沙坦氨氯地平片(III)浙江昂利康制药股份有限公司3CYHS2501230维生素B6注射液湖南先施制药有限公司3CYHS2501229厄贝沙坦氨氯地平片(I)浙江昂利康制药股份有限公司3CYHS2501228重酒石酸卡巴拉汀口服液海南海和制药有限公司3CYHS2501227重酒石酸卡巴拉汀口服液海南海和制药有限公司3CYHS2501226盐酸依匹斯汀滴眼液参天制药(中国)有限公司3CYHS2501218法莫替丁注射液山西铭羽生物科技有限公司3CYHS2501216法莫替丁注射液山西铭羽生物科技有限公司3CYHS2501215维生素B6注射液西洲医药科技(浙江)有限公司3CYHS2501201琥珀酸亚铁片山西同达药业有限公司3CYHS2501200琥珀酸亚铁片上海金不换兰考制药有限公司3CYHS2501199布美他尼注射液重庆博腾药业有限公司3CYHS2501196吡格列酮二甲双胍片上海青平药业有限公司3CYHS2501195罗沙司他片石家庄市华新药业有限责任公司3CYHS2501188盐酸伊立替康脂质体注射液石药集团欧意药业有限公司3CYHS2501187复方聚乙二醇电解质散(儿童型)福州基石医药科技有限公司3CYHS2501182硝普钠注射液中润药业有限公司3CYHS2501180硝普钠注射液山西九康医药科技有限公司3CYHS2501176硝普钠注射液海南海和制药有限公司3CYHS2501159比拉斯汀口服溶液湖南科伦制药有限公司3CYHS2501158盐酸丁螺环酮片浙江京新药业股份有限公司3CYHS2501157盐酸丁螺环酮片浙江京新药业股份有限公司3CYHS2501156山梨醇甘露醇冲洗剂西安京西双鹤药业有限公司3CYHS2501155铝碳酸镁混悬液江苏润恒制药有限公司3CYHS2501173盐酸精氨酸注射液四川邈济生物医药科技有限公司3CYHS2501162碳酸氢钠注射液安徽双鹤药业有限责任公司3CYHS2501161注射用吲哚菁绿仁合益康汇泽药业河北有限公司3CYHS2501160聚多卡醇注射液苏州朗科生物技术股份有限公司4CYHS2501225聚多卡醇注射液苏州朗科生物技术股份有限公司4CYHS2501224聚多卡醇注射液苏州朗科生物技术股份有限公司4CYHS2501223甲磺酸溴隐亭片江苏诚康药业有限公司4CYHS2501222乌帕替尼缓释片复星万邦(江苏)医药集团有限公司4CYHS2501221乌帕替尼缓释片复星万邦(江苏)医药集团有限公司4CYHS2501220乌帕替尼缓释片复星万邦(江苏)医药集团有限公司4CYHS2501219盐酸尼卡地平注射液国药集团容生制药有限公司4CYHS2501217注射用氟氧头孢钠齐鲁安替制药有限公司4CYHS2501214注射用氟氧头孢钠齐鲁安替制药有限公司4CYHS2501213盐酸托莫西汀口服溶液山东步长制药股份有限公司4CYHS2501212利多卡因凝胶贴膏南京海纳医药科技股份有限公司4CYHS2501211双氯芬酸二乙胺乳胶剂湖南九典制药股份有限公司4CYHS2501210苯磺酸左氨氯地平片河南普瑞药业有限公司4CYHS2501209苯磺酸左氨氯地平片河南普瑞药业有限公司4CYHS2501208硫酸氨基葡萄糖胶囊山东诚康药业有限公司4CYHS2501207棕榈酸帕利哌酮注射液石药集团中诺药业(石家庄)有限公司4CYHS2501206棕榈酸帕利哌酮注射液石药集团中诺药业(石家庄)有限公司4CYHS2501205棕榈酸帕利哌酮注射液石药集团中诺药业(石家庄)有限公司4CYHS2501204比拉斯汀片桂林南药股份有限公司4CYHS2501203阿帕他胺片成都倍特药业股份有限公司4CYHS2501202舒更葡糖钠注射液海南斯达制药有限公司4CYHS2501198妥布霉素滴眼液深圳大佛药业股份有限公司4CYHS2501197硫酸氨基葡萄糖胶囊南京海鲸药业股份有限公司4CYHS2501194骨化三醇注射液山西康成利安医药有限公司4CYHS2501193地夸磷索钠滴眼液广东恒健制药有限公司4CYHS2501192硫酸氨基葡萄糖胶囊山东诺禾康药业有限公司4CYHS2501191骨化三醇注射液河南泰丰生物科技有限公司4CYHS2501190达格列净片山东普瑞曼药业有限公司4CYHS2501189艾普拉唑肠溶片浙江高跖医药科技股份有限公司4CYHS2501186阿奇霉素干混悬剂云鹏医药集团有限公司4CYHS2501185氟比洛芬凝胶贴膏湖南金圃医药科技有限公司4CYHS2501184布洛芬缓释胶囊郑州泰丰制药有限公司4CYHS2501183阿帕他胺片正大天晴药业集团南京顺欣制药有限公司4CYHS2501181沙库巴曲缬沙坦钠片海南赛立克药业有限公司4CYHS2501179沙库巴曲缬沙坦钠片海南赛立克药业有限公司4CYHS2501178沙库巴曲缬沙坦钠片海南赛立克药业有限公司4CYHS2501177玻璃酸钠滴眼液石家庄四药有限公司4CYHS2501175玻璃酸钠滴眼液石家庄四药有限公司4CYHS2501174阿莫西林克拉维酸钾干混悬剂山东益康药业股份有限公司4CYHS2501154黄体酮软胶囊深圳大佛药业股份有限公司4CYHS2501171黄体酮软胶囊深圳大佛药业股份有限公司4CYHS2501170乳果糖口服溶液湖北午时药业股份有限公司4CYHS2501168蛋白琥珀酸铁口服溶液中山百灵生物技术股份有限公司4CYHS2501167八氟丙烷脂质微球注射液广州康臣药业有限公司4CYHS2501166硫酸镁钠钾口服用浓溶液湖北午时药业股份有限公司4CYHS2501165富马酸伏诺拉生片蚌埠丰原涂山制药有限公司4CYHS2501164富马酸伏诺拉生片蚌埠丰原涂山制药有限公司4CYHS2501163乌帕替尼缓释片上海信谊百路达药业有限公司4CYHS2501172硫酸氨基葡萄糖胶囊江苏诺泰澳赛诺生物制药股份有限公司4CYHS2501169破伤风人免疫球蛋白浙江海康生物制品有限责任公司3.4CXSS2500038盐酸达克罗宁局部溶液剂深圳珐玛易药品科技有限公司3CYHL2500073溴莫尼定凝胶深圳珐玛易药品科技有限公司3CYHL2500072酮洛芬贴剂北京福元医药股份有限公司3CYHL2500071酮洛芬贴剂北京福元医药股份有限公司3CYHL2500070盐酸毛果芸香碱滴眼液苏州欧康维视生物科技有限公司3CYHL2500067米诺地尔泡沫剂深圳珐玛易药品科技有限公司3CYHL2500066双氯芬酸依泊胺贴深圳珐玛易药品科技有限公司3CYHL2500065硝呋太尔制霉菌素阴道软胶囊山东华铂凯盛生物科技有限公司4CYHL2500069沙美特罗替卡松吸入粉雾剂杭州知兴制药有限公司4CYHL2500068吸附破伤风疫苗北京智飞绿竹生物制药有限公司3.3CXSL2500250流感病毒裂解疫苗陕西昆秦生物科技有限公司3.3CXSL2500243进口申请药品名称企业注册分类受理号艾伏尼布片Servier Pharmaceuticals LLC5.1JXHS2500042利多卡因丙胺卡因气雾剂PLETHORA SOLUTIONS LIMITED5.1JXHS2500041度伐利尤单抗注射液AstraZeneca UK Limited3.1JXSS2500038度伐利尤单抗注射液AstraZeneca UK Limited3.1JXSS2500037PF-07985045片Pfizer Inc.1JXHL2500066PF-07985045片Pfizer Inc.1JXHL2500065Orforglipron胶囊Eli Lilly and Company1JXHL2500064Orforglipron胶囊Eli Lilly and Company1JXHL2500063Orforglipron胶囊Eli Lilly and Company1JXHL2500062Orforglipron胶囊Eli Lilly and Company1JXHL2500061Orforglipron胶囊Eli Lilly and Company1JXHL2500060Orforglipron胶囊Eli Lilly and Company1JXHL2500059TPST-1120片Tempest Therapeutics, Inc.1JXHL2500058Golcadomide胶囊Celgene Corporation1JXHL2500055Golcadomide胶囊Celgene Corporation1JXHL2500054Golcadomide胶囊Celgene Corporation1JXHL2500053Golcadomide胶囊Celgene Corporation1JXHL2500052醋酸甲地孕酮口服混悬液TWi Pharmaceuticals, Inc.2.4JXHL2500056罗氟司特泡沫Arcutis Biotherapeutics INC5.1JXHL2500057Empasiprubart注射用浓溶液argenx BV1JXSL2500047DS-1062aASTRAZENECA AB1JXSL2500045AZD2936AstraZeneca AB1JXSL2500044AZD2936AstraZeneca AB1JXSL2500042仑卡奈单抗注射液(皮下注射)Eisai Co., Ltd.2.1JXSL2500046TarlatamabAmgen Inc.2.2JXSL2500041TarlatamabAmgen Inc.2.2JXSL2500040TarlatamabAmgen Inc.2.2JXSL2500039帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2500043中药相关申请药品名称企业注册分类受理号桃核承气汤颗粒合肥华润神鹿药业有限公司3.1CXZS2500012肺热咳喘颗粒海南葫芦娃药业集团股份有限公司2.3CXZL2500020注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。