5-HT1A receptor agonists(Serotonin 1a (5-HT1a) receptor agonists), 5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor partial agonists(Dopamine D2 receptor partial agonists)

Therapeutic Areas

Nervous System DiseasesOther DiseasesCardiovascular Diseases+ [1]

Active Indication

Depressive Disorder, MajorBipolar and Related DisordersBipolar Disorder+ [7]

Inactive Indication

Bipolar II disorderChronic schizophreniaGeneralized anxiety disorder+ [2]

Originator Organization

Chemical Works of Gedeon Richter Plc

Active Organization

AbbVie, Inc.

Qilu Pharmaceutical Co., Ltd.Gedeon Richter (UK) Ltd.

+ [4]

Inactive Organization

Forest Laboratories LLC

Tanabe Pharma Corp.Gedeon Richter Pharma GmbH

+ [1]

License Organization

Gedeon Richter (UK) Ltd.

Chemical Works of Gedeon Richter Plc

Hikma Pharmaceuticals Plc

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (17 Sep 2015),

Bipolar I disorderSchizophrenia

Regulation-

Structure/Sequence

Molecular FormulaC21H33Cl3N4O

InChIKeyGPPJWWMREQHLQT-BHQIMSFRSA-N

CAS Registry1083076-69-0

Clinical Trials associated with Cariprazine hydrochloride

NCT07715253

/ Not yet recruitingPhase 1IIT

Longitudinal PET Imaging of Antipsychotic Binding to the Dopamine-3 Receptor in Schizophrenia

This is a clinical trial in which 40 participants with schizophrenia will be randomized to 15 days of treatment with cariprazine (CAR) or brexpiprazole (BREX) in a single-blind manner. [11C]PHNO PET scans will be obtained before treatment and after 1 day and 15 days of treatment to examine the effects of antipsychotic medications on the dopamine-3 receptor (D3R). The overall objectives of the current study are to: 1) measure the acute binding of CAR/BREX to the D3R; 2) measure D3R availability for evidence of upregulation following subchronic administration of CAR/BREX in the same set of patients; 3) examine relationships between subchronic binding of CAR/BREX to, and upregulation of, the D3R vs. D2R and changes in positive symptoms, negative symptoms, and cognitive deficits. Relationships between subchronic binding of CAR/BREX and EPS will be explored.

Start Date01 Dec 2026

Sponsor / Collaborator

The New York State Psychiatric Institute

[+3]

NCT07722728

/ Not yet recruitingPhase 2/3

An Open-label, Randomized, Single-dose (Long-acting Injectable) or Multiple-dose (Oral) Clinical Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of B2227 Extended-Release Injectable Suspension and Vraylar® in Participants With Schizophrenia

The study is to evaluate the pharmacokinetic profile of B2227 Extended-Release Injectable Suspension against Vraylar® Cariprazine capsules of AbbVie Inc. in participants with schizophrenia.

Start Date01 Aug 2026

Sponsor / Collaborator

Guangzhou Bosto Controlled-Release Pharmaceutical Co Ltd.

NCT07484204

/ Not yet recruitingPhase 1

An Open-label, Multicenter Study to Determine the Pharmacokinetics, Safety, and Tolerability of AX251 Long-Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia

The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AX251 long-acting injectable (LAI) administered as a single dose in patients with schizophrenia. The study will include sequential dose-escalation cohorts to evaluate different dose levels of AX251 LAI.

Start Date01 Jul 2026

Sponsor / Collaborator

Anxo Pharmaceutical Co., Ltd.

100 Clinical Results associated with Cariprazine hydrochloride

100 Translational Medicine associated with Cariprazine hydrochloride

100 Patents (Medical) associated with Cariprazine hydrochloride

598

Literatures (Medical) associated with Cariprazine hydrochloride

01 Sep 2026·CNS DRUGS

Adjunctive Pharmacotherapy for Major Depressive Disorder with Anxiety Symptoms: from Monoamines to Recent Clinical Evidence

Review

Author: Kato, Masaki ; Ardic, Ferhat ; Ikehara, Kenta ; McIntyre, Roger S ; Boucher, Matthieu ; Thase, Michael E ; Therrien, François ; Marrache, A Marilise

Anxiety symptoms are common in patients with major depressive disorder (MDD). The presence of anxiety symptoms can indicate greater depression severity, and is associated with a higher comorbidity burden, suicidality, lower levels of functioning, and poorer quality of life. The presence of anxiety identifies patients who are likely to experience significant burden from MDD despite standard treatment. Although clinical guidelines provide recommendations for adjunctive treatment in patients who have not responded to an antidepressant, there are currently limited recommendations specifically for patients with MDD and anxiety symptoms. Dysregulation of the monoamine system, notably noradrenaline (norepinephrine), serotonin, and dopamine signalling, has been implicated in the pathophysiology of MDD and of anxiety disorders, based mainly on preclinical, mechanistic and translational evidence. This review has two aims: (1) to explore the hypothetical role of monoamine signalling in patients with MDD with anxiety symptoms, and (2) to provide a comprehensive overview of clinical data for pharmacotherapies recommended for the first- and second-line adjunctive treatment of difficult-to-treat MDD, focusing on recent studies and analyses of patients with MDD with anxiety symptoms. Reviewed treatments included atypical antipsychotics (aripiprazole, brexpiprazole, olanzapine, quetiapine XR, risperidone, cariprazine), bupropion, ketamine/esketamine, lithium, mirtazapine/mianserin, modafinil, and triiodothyronine. Clinical data in patients with MDD with anxiety symptoms were scarce or lacking for olanzapine, risperidone, cariprazine, lithium, modafinil, and triiodothyronine. Aripiprazole, brexpiprazole, quetiapine XR, and ketamine/esketamine have been shown to improve depression and/or anxiety symptoms in patients with MDD with anxiety symptoms, although evidence is mainly short-term and derived from exploratory post hoc analyses of trials not designed to assess anxiety outcomes. Treatment decisions for patients with MDD with anxiety symptoms should be based on robust clinical data, and there is an unmet need for prospective clinical trials with anxiety-specific endpoints in this patient population.

01 Aug 2026·BIPOLAR DISORDERS

Risk of Major Malformations Following First‐Trimester Exposure to Cariprazine: Preliminary Data From the MGH National Pregnancy Registry for Psychiatric Medications

Article

Author: Gaccione, Peter ; Chitayat, David ; Hernández‐Díaz, Sonia ; Freeman, Marlene P. ; Manuelian, Ana M. ; Cohen, Lee S. ; Slaby, Ella K. ; Viguera, Adele C.

ABSTRACT:

Objective:

Systematically collected pregnancy safety data for cariprazine have been lacking, despite growing use of this medication across psychiatric indications. The goal of this analysis was to determine the risk of major malformations among infants of mothers with psychiatric illness who used cariprazine during the first trimester of pregnancy compared to unexposed controls.

Methods:

The National Pregnancy Registry for Psychiatric Medications (NPRPM) is a prospective pharmacovigilance program in which pregnant women with psychiatric diagnoses are enrolled during pregnancy and followed through the postpartum period. Labor and delivery and pediatric medical records are reviewed for evidence of major malformations followed by final adjudication by a dysmorphologist blinded to medication exposure. Infants with first‐trimester exposure to cariprazine were compared to controls not exposed to second‐generation antipsychotic medications.

Results:

As of September 9, 2025, N = 4,125 have enrolled in the study. Of those enrolled, 58 cariprazine‐exposed infants and 2,098 infants in the comparison group were eligible for inclusion in this analysis. There were no major malformations in the cariprazine‐exposed group (absolute risk 0.00%; 95% confidence interval, 0.00%–6.16%) compared to 32 infants with major malformations in the control group (1.53%; 1.05%–2.15%).

Conclusions:

In this prospective cohort, 0 of 58 infants exposed to cariprazine during the first trimester had major malformations, compared with 32 of 2,098 (1.53%) unexposed infants. Although these data are preliminary and cannot rule out modest teratogenic effects, they are nonetheless important to provide to health care providers and the public, as cariprazine use has been rising among women of reproductive age.

01 Aug 2026·CLINICAL AUTONOMIC RESEARCH

Cardiovascular pharmacology of dopaminergic agents in humans: a review

Review

Author: Palma, Jose-Alberto ; Gomez Casanovas, Jose G

PURPOSE:

To review the cardiovascular effects of pharmacologic dopamine receptor modulation in humans, organized by receptor subtype.

METHODS:

Narrative review of human pharmacological, genetic, and clinical evidence linking dopamine receptor agonism and antagonism to blood pressure and heart rate changes in healthy volunteers and in patients with Parkinson disease, autonomic failure, psychiatric disorders, and selected cardiovascular conditions.

RESULTS:

Dopaminergic receptor agonism generally lowers blood pressure, with the magnitude of hypotension tracking with intrinsic activity: full orthosteric agonists (bromocriptine, ropirinole, apomorphine) carry the highest risk of orthostatic hypotension, and partial agonists (tavapadon) produce attenuated but clinically relevant hypotension. Dopamine D3-preferring agents (PF-592379, mesdopetam, cariprazine) have neutral cardiovascular effects in short-term trials. Levodopa-induced orthostatic hypotension arises from at least five converging mechanisms whose clinical impact is amplified by underlying neurogenic orthostatic hypotension. A notable exception is mevidalen, a centrally acting dopamine D1 positive allosteric modulator that paradoxically raises blood pressure. Despite murine knockout models consistently predicting that dopamine receptor deletion produces hypertension, pharmacological antagonism in humans does not reliably raise blood pressure: dopamine D1, D2, and D3 antagonists show largely neutral cardiovascular profiles, while antipsychotic-associated orthostatic hypotension is driven primarily by α1-adrenergic blockade.

CONCLUSIONS:

The cardiovascular response to dopaminergic agents depends on receptor selectivity, intrinsic activity, and baroreflex integrity. The discrepancy between murine-knockout-predicted hypertension and human pharmacological neutrality with antagonists, and the hypertensive effects of dopamine D1 positive allosteric modulators, represent key unresolved questions.

108

News (Medical) associated with Cariprazine hydrochloride

18 Aug 2026

·www.biospace.com

Helus Pharma Appoints Regina Donohue as Chief People Officer and Suresh Durgam, M.D., to its Scientific Advisory Board

Former Intra-Cellular Therapies, Inc. (“Intra-Cellular”) executives bring complementary experience in organizational scale-up, central nervous system (“CNS”) drug development, regulatory approvals and commercialization Ms. Donohue is the former Chief Human Resources Officer of Intra-Cellular, where she led the company’s people strategy and human resources infrastructure as it transitioned from a clinical to a commercial stage organization of 1,000+ employees Dr. Durgam is a recognized CNS drug-development leader who played a pivotal role in securing multiple U.S. Food and Drug Administration (“FDA”) approvals for CAPLYTA® (lumateperone), including in schizophrenia, bipolar depression and adjunctive major depressive disorder Appointments support Helus Pharma’s continued growth, scientific leadership and preparation for potential commercialization This news release constitutes a “designated news release” for the purpose of the Company’s prospectus supplement dated December 30, 2025, to its short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025. NEW YORK and TORONTO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”), a clinical-stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today announced the appointment of Regina Donohue as Chief People Officer and the appointment of Suresh Durgam, M.D., to the Company’s Scientific Advisory Board (“SAB”). “I had the pleasure of working with both Regina and Suresh at Intra-Cellular, and I am delighted to welcome them to Helus Pharma,” said Michael Halstead, Chief Executive Officer of Helus Pharma. “As we execute against our upcoming clinical, regulatory and commercial milestones, Regina’s experience thoughtfully scaling organizations and building high-performing teams will be instrumental. Suresh’s deep expertise in CNS clinical development, regulatory strategy and scientific leadership will further strengthen our SAB as we advance our pipeline toward potential commercialization.” Chief People Officer Appointment Ms. Donohue has extensive human resources leadership experience working with life sciences companies amidst their transition from clinical platforms through commercialization by building scalable human resources functions through periods of rapid growth. Most recently, at Intra-Cellular, Ms. Donohue served as Chief Human Resources Officer, where she built the company’s people strategy and infrastructure, and managed its rapid growth as it transitioned into a commercial-stage organization, launched its first product, and grew to 1,000+ employees. Intra-Cellular was acquired by Johnson & Johnson in April 2025. Previously, Ms. Donohue was among the first five executives hired to build LEO Pharma’s U.S. subsidiary, establishing its human resource function and supporting the organization through the rapid growth necessary to launch two products in the U.S. During her tenure at LEO Pharma, she also served as the interim Global Head of Human Resources. “I am thrilled to join a company so deeply committed to advancing innovative treatments for people living with mental health conditions,” said Ms. Donohue. “Mental health is a cause that is personally meaningful to me, and I am particularly excited to bring my experience and passion for building strong, purpose-driven organizations to Helus Pharma. The Company is at an exciting stage of its growth, and I look forward to helping build a patient-centric culture and developing the strong people strategy Helus Pharma will need as it advances towards potential commercialization of its programs.” Ms. Donohue holds a Bachelor of Science from the University of Scranton and professional human resources designations from the HR Certification Institute and Society for Human Resources Management. SAB Appointment Dr. Durgam is a CNS drug-development executive with more than two decades of experience spanning clinical development, medical affairs, regulatory strategy and pharmacovigilance. Most recently, he served as Executive Vice President and Chief Medical Officer of Intra-Cellular, where he provided strategic oversight across global clinical development and operations, data science, regulatory affairs, drug safety and medical affairs. He played a pivotal role in securing FDA approvals for CAPLYTA across multiple indications, including schizophrenia, bipolar depression, as both a monotherapy and adjunctive therapy, and adjunctive major depressive disorder. Earlier in his career, Dr. Durgam held senior clinical-development leadership roles at Allergan, Forest Laboratories and Solvay Pharmaceuticals, with responsibility for programs across major depressive disorder, bipolar disorder, schizophrenia and anxiety disorders. His development experience includes lumateperone, cariprazine, vilazodone, levomilnacipran and other CNS therapies. He has led or supported numerous interactions with regulatory authorities worldwide and authored or co-authored more than 50 peer-reviewed publications and over 200 abstracts and posters. “Helus Pharma is advancing a differentiated CNS pipeline with the potential to address significant unmet needs in mental health,” said Dr. Durgam. “I look forward to working with the Company’s leadership team and fellow SAB members to provide scientific and clinical guidance as Helus Pharma advances its programs through late-stage development.” Dr. Durgam received his psychiatry residency training at Scott & White Memorial Hospital within the Texas A&M University System College of Medicine and earned his medical degree from Siddhartha Medical College in India. He is a member of the Scientific Committee of the International Society for CNS Clinical Trials and Methodology and received the 2026 International Society for CNS Drug Development Leadership Award. About Helus Pharma Helus Pharma™, the commercial operating name of Cybin Inc. is a clinical stage pharmaceutical company committed to helping minds heal by developing proprietary NSAs, synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The Company’s proprietary NSAs are intended to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions. With class leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in Phase 3 clinical development for the adjunctive treatment of MDD that has received Breakthrough Therapy Designation from the FDA and HLP004, also a proprietary NSA in Phase 2 for GAD. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs. The Company operates in Canada, the United States, the United Kingdom, and Ireland. For Company updates and to learn more about Helus Pharma, visit or follow the team on X, LinkedIn, YouTube and Instagram. Helus Pharma™ is a trademark of Helus Pharma Corp. Cautionary Notes and Forward-Looking Statements Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, “forward-looking statements”) and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “potential”, “possible”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the anticipated contributions of Ms. Donohue and Dr. Durgam; the Company’s continued growth and commercialization of the Company’s programs; execution against clinical, regulatory and commercial milestones; and plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the NSA market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three months ended June 30, 2026, and the Company’s annual information form for the year ended March 31, 2026, which are available under the Company's pro SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The FDA, Health Canada or other similar regulatory authorities have not evaluated claims regarding NSAs or HLP003, HLP004 and other programs of the Company. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of NSAs, HLP003, HLP004 or other programs of the Company can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Helus Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations. Neither Cboe Canada, nor the Nasdaq Global Market stock exchange, have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein. Investor Contact: Matthew Beck astr partners Managing Partner (917) 415-1750 Matthew.beck@astrpartners.com Gabriel Fahel Chief Legal Officer Helus Pharma 1-866-292-4601 irteam@helus.com – or – media@helus.com Media Contact: Victoria Verdeja RXMD Public Relations Director (212) 537-9495 cwray@rxmedyn.com

Executive ChangeDrug ApprovalPhase 2

12 Aug 2026

·www.biospace.com

Mapi Pharma Announces Initial Phase I/IIa Clinical Results Supporting Continued Development of Once-Monthly Cariprazine Depot

NESS ZIONA, Israel, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd. (“Mapi” or the “Company”), a late-stage clinical biopharmaceutical company specializing in long-acting injectable therapies, today announced initial clinical results from its on-going Phase I/IIa trial that support continued development of once-monthly Cariprazine Depot. Cariprazine is a well-established atypical antipsychotic approved for the treatment of schizophrenia, bipolar I disorder and major depressive disorder (MDD). It is currently available only as a once-daily oral therapy. However, clinicians treating chronic psychiatric conditions generally prefer long-acting injectable (LAI) formulations of anti-psychotic medications, due to their ability to improve treatment adherence, reduce relapse risk and simplify long-term disease management. Mapi Pharma is developing Cariprazine Depot , a once-monthly subcutaneous (SC) long-acting injectable formulation of cariprazine, using its proprietary depot technology. Designed to provide sustained drug release over one month, Cariprazine Depot has the potential to address an important unmet need by offering a convenient long-acting treatment option for patients with schizophrenia, bipolar disorder and MDD. Vraylar cariprazine capsules (marketed in the US by AbbVie and covered by a patent that will expire in 2029) generated net revenues of $3.6 billion in global sales in 2025, highlighting the significant commercial potential for an LAI formulation. Phase I/IIa Clinical Study Design ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The ongoing prospective, dose-escalating, open-label, multi-center, Phase I/IIa study is designed to evaluate the pharmacokinetics (PK), safety and tolerability of once-monthly SC injections of Cariprazine Depot in subjects eligible for treatment with oral cariprazine. Following a washout period, participants received a single 22 mg subcutaneous injection of Cariprazine Depot. For more information on the design refer to ClinicalTrials.gov: NCT07185815. Top-Line Results Top-line results from Cohort 1 are now available. The results demonstrated that Cariprazine Depot exhibited a safety pro with the established safety pro oral cariprazine. Key findings included: No serious adverse events (SAEs) were reported. All treatment-related adverse events associated with Cariprazine Depot were mild. Injection site reactions (ISRs) were mild, with injection site pain resolving rapidly (mean duration of less than one day). Treatment-related non-ISR adverse events occurred in fewer participants and were less frequent with Cariprazine Depot than with oral cariprazine. Each patient was treated at the beginning with oral cariprazine, and their data was analyzed. Overall, once-monthly Cariprazine Depot administered as add-on therapy was safe and well tolerated. These encouraging results support the continued clinical development of Cariprazine Depot as a potential long-acting treatment option for patients requiring cariprazine therapy. Ehud Marom, Chairman and Chief Executive Officer, Mapi Pharma, said, “We are excited to announce the excellent clinical results and are planning to submit an IND to the U.S. FDA by the end of 2026 with a partner who is expected to support the Phase 3 and lead marketing. Mapi will be responsible for drug manufacturing for clinical studies and the commercial supply from it’s GMP approved facilities. If successful in Phase 3, an NDA submission is planned for 2029”. About Mapi Pharma Mapi Pharma is a clinical-stage pharmaceutical company focused on the development of high-value, complex injectable therapies with significant barriers to entry. The Company’s portfolio includes long-acting depot formulations targeting large and growing markets, including central nervous system disorders and metabolic diseases. Key pipeline programs include long-acting formulations of Cariprazine, as well as GLP-1 therapies such as Semaglutide and Tirzepatide for diabetes and weight management. Mapi is also developing an AB-rated generic version of Naltrexone (Vivitrol ® ) and markets generic versions of Fingolimod (Gilenya ® ) and Apremilast (Otezla ® ) in select regions. Mapi combines deep expertise in chemistry, pharmaceutical development, and clinical execution with a strong intellectual property portfolio, including numerous granted patents primarily focused on formulations. The Company operates dedicated R&D and aseptic manufacturing facilities for long-acting injectable dosage forms. For more information, please visit Contacts: Alex Mogle Vice President, Corporate Development Mapi Pharma +972 52 6080297 alex@mapi-pharma.com Brian Ritchie Managing Director LifeSci Advisors, LLC britchie@lifesciadvisors.com

Clinical ResultNDAPhase 3

07 Aug 2026

·www.gedeonrichter.com

Richter publishes Q2/H1 2026 results

CER Pharma revenues grew by 8.7%, driven by CNS and BIO and also reflecting improving WHC and GenMed dynamics in Q2. Reported Pharma revenues declined by 0.5% YoY to HUF 455bn in H1 2026, implying around 9ppt currency headwind. CER Clean EBIT (pharma) growth was outstanding at 21%, driven by the outperformance of cariprazine and the benefits of our multi-year efficiency initiatives; reported Clean EBIT (pharma) grew by only 3% to HUF 151.8bn. Net profit was HUF 103.5bn in H1 2026, down by 14% YoY due to large, HUF 27.1bn FX losses burdening the period. Free Cash Flow generation was up by a solid 24% YoY to HUF 137bn. 2026 Clean EBIT guidance (at constant exchange rates, CER) is upgraded to “double-digit growth” on the back of the strong H1 profitability. Budapest, 7 August 2026 - Gedeon Richter Plc. (“Richter”) announced today its Q2/H1 2026 financial results. CER (constant exchange rate) Pharma revenues grew by 8.7% in H1 2026, in line with the high-single-digit growth guidance for the full year and reflected improving dynamics in Q2. FX remains a major drag on reported revenues and represented around 9ppt headwind in H1 (primarily due to the strong HUF). Hence, reported Pharma revenues declined by 0.5% YoY to HUF 455bn in H1 2026. CNS revenues increased by 7% in H1 2026 YoY, as currency movements partly offset the impressive performance of Vraylar® (AbbVie’s net sales increased by 19% YoY to USD 1.98bn reflecting strong demand growth and market share gains in both bipolar disorder and adjunctive MDD) and jumping Reagila® sales (+25% CER, driven by higher supply revenues and high-performing countries in both Richter and partner territories). Women’s Healthcare sales growth (+7% CER in H1) accelerated in Q2 as Endometriosis and Menopause consistently outperform expectations. Lower Eastern European sales and slower dynamics in traditional OC products continue to affect top-line growth. The underlying strength of the leading products (Drovelis®, Ryeqo®, Lenzetto® and Bemfola®) remains intact. BIO revenues jumped in H1 (+30% CER), driven by biosimilar revenues (very strong teriparatide sales and new product launches). GenMed revenues fell by 5% in H1 YoY (CER) although sales dynamics have incrementally been improving. The lack of flu season (weak OTC), a high base and the ongoing rationalization of distributors’ inventory holding affected top-line. Gross profit (pharma) fell by 2.2% YoY to HUF 314bn in H1 2026; gross margin declined to 69% (-1.2ppt), despite improving trends in Q2. CER Clean EBIT (pharma) growth was outstanding at 21% in H1 2026, driven by the outperformance of cariprazine, improving WHC profitability and also supported by lower opex. Reported Clean EBIT (pharma) grew by only 3% to HUF 151.8bn due to the FX headwind. Reported EBIT stood at HUF 143.5bn in H1 2026, 2.2% higher YoY. Net profit (attributable to the owners of the parent) was HUF 103.5bn in H1 2026, declining by 14% YoY, as a result of large, HUF 27.1bn FX losses (mostly unrealized yet) burdening the period as financial expenses. Free cash flow (before M&A) was at another record-high of HUF 137bn in H1 2026, up 24% YoY, driven by lower Net Working Capital funding need vs. a year ago, and higher operating profits, partly offset by FX losses. The multi-year project to optimize and centralize API (active pharmaceutical ingredient) manufacturing in Hungary was completed. The project reduces duplications, improves efficiency, leads to a more compact site structure in Budapest and makes Dorog the API manufacturing site of Richter. Centralizing API manufacturing not only brought in much improved operational efficiency, but also delivered significant environmental benefits. This includes significantly lower energy consumption, materially less overall wastewater and hazardous waste generation, reduced net operational areas and an improved industrial footprint. Gábor Orbán, CEO commented the results: “Top-line growth accelerated in Q2, fully in line with our high-single-digit (CER) growth target for the year, driven by improving dynamics in both Women’s Healthcare and GenMed alongside sustained strength in CNS and BIO revenues. We are upgrading our profitability guidance for 2026 to double-digit Clean EBIT growth (CER), reflecting the outstanding performance of Vraylar® and visible benefits of our multi-year efficiency initiatives. Reported financial results continue to be affected by currency trends. We successfully launched Fylrevy®, an innovative hormone therapy for menopause, in selected pilot markets in Europe; Tuyory®, our tocilizumab biosimilar is now being commercialized; another CNS molecule (RGH-202) is entering Phase II clinical trials; and we further expand our GLP-1 portfolio through global partnerships.” About Gedeon Richter Plc. Richter aspires to be a global innovator in some key scientific fields, while dedicated to making medicines more accessible worldwide. Founded in 1901, headquartered in Hungary, with a market capitalization of EUR 4.8bn and sales of EUR 2.3bn in 2025, it operates Central Europe's largest R&D hub. Its research drives breakthroughs in Neuropsychiatry and Women's Healthcare, while Biotechnology and General Medicines strengthen its affordable treatment portfolio. Committed to sustainable growth, Richter invests in R&D, manufacturing excellence, and digitalization to advance medical innovation. Learn more at www.gedeonrichter.com For further information: Investors: Róbert Réthy, CFA +36 20 342 2555 Media: Zsuzsa Beke +36 20 916 4507

Phase 2Financial Statement

100 Deals associated with Cariprazine hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D09876	Cariprazine hydrochloride	N05AX15	DB06016

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Depressive Disorder, Major	United States	AbbVie, Inc.	16 Dec 2022
Bipolar and Related Disorders	Canada	Gedeon Richter (UK) Ltd.	27 Apr 2022
Bipolar Disorder	Canada	Allergan, Inc.	22 Apr 2022
Bipolar I disorder	United States	AbbVie, Inc.	17 Sep 2015
Schizophrenia	United States	AbbVie, Inc.	17 Sep 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Heart Septal Defects, Atrial	Phase 3	United States	AbbVie, Inc.	07 Jul 2022
Irritable Mood	Phase 3	United States	AbbVie, Inc.	07 Jul 2022
Acute schizophrenia	Phase 3	South Korea	Whan In Pharmaceutical Co., Ltd.	19 Nov 2021
Autism Spectrum Disorder	Phase 3	United States	AbbVie, Inc.	01 Feb 2021
Depressive Disorder	Phase 3	Bulgaria	Forest Laboratories LLC	17 Mar 2016
Depressive Disorder	Phase 3	Estonia	Forest Laboratories LLC	17 Mar 2016
Depressive Disorder	Phase 3	Lithuania	Forest Laboratories LLC	17 Mar 2016
Depressive Disorder	Phase 3	Poland	Forest Laboratories LLC	17 Mar 2016
Chronic schizophrenia	Phase 3	Japan	Tanabe Pharma Corp.	01 May 2012
Mania	Phase 3	United States	Forest Laboratories LLC	01 Feb 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03738215 (Pubmed \| J Clin Psychiatry)	Phase 3	Depressive Disorder, Major	751	Cariprazine 1.5 mg/d + ADT	qncofvxwog(wwdsjdopux) = bxpkmhgjnw isgzhhhxgs (oepdtatglo, -2.5 to -0.1) View more	Positive	30 Apr 2025
				Cariprazine 3.0 mg/d + ADT	ychubdrrpj(noblehyijd) = kzztckiond kkncvtfvhm (jzhogmpeaa, -1.0 to -0.1)
NEWS Manual	Not Applicable	Schizophrenia	116	cariprazine (women outpatients)	npppefpfbh(hwwpkkkggg) = There was a significant change from baseline in women to week 16 in the SAND scores: negative symptoms decreased by 6.2, positive symptoms decreased with 1.0, which is a remarkable, combined 7.2 drop. ybtzabdfij (eklgoygael )	Positive	18 Oct 2023
NCT03573297 (CTgov)	Phase 3	Mania \| Depressive Disorder \| Bipolar I disorder	901	placebo (Double-Blind Placebo QD)	rrxyjtebjs(lopgjqdlcr) = naqbccslwz qnbdvakltl (zvfqyncfcj, xlkbtwofdd - ituoxbehhj) View more	-	28 Sep 2023
				Cariprazine (Double-Blind Cariprazine 1.5 mg QD)	rrxyjtebjs(lopgjqdlcr) = boybxrmbih qnbdvakltl (zvfqyncfcj, uxarlarnvm - lqqwfhtsfv) View more
NCT03738215 (Pubmed \| Am J Psychiatry)	Phase 3	Depressive Disorder, Major	751	Placebo	ysriwtsdkm(zrovxzdgyr) = kqgpbyxdcl vytpnxuuhm (mvpzfxvjks )	Positive	15 Feb 2023
				Cariprazine 1.5 mg/day	ysriwtsdkm(zrovxzdgyr) = exoofvafqv vytpnxuuhm (mvpzfxvjks )
NCT03738215 (CTgov)	Phase 3	Depressive Disorder, Major	759	Placebo (Placebo + ADT)	slvilnctzq(wwfbdcnjhx) = ljewtwsxdz nuobthiwgm (biukxqealz, 0.70) View more	-	25 Oct 2022
				Cariprazine (Cariprazine 1.5 mg/Day + ADT)	slvilnctzq(wwfbdcnjhx) = swbxicovxc nuobthiwgm (biukxqealz, 0.70) View more
NCT03739203 (CTgov)	Phase 3	Depressive Disorder, Major	752	Placebo (Placebo + ADT)	lsnlsovxof(wwfkeytwyw) = tbohrmgqnw zvppmwlhgj (sudoggyhzh, 0.70) View more	-	21 Sep 2022
				ADT+Cariprazine (Cariprazine 1.5 mg/Day + ADT)	lsnlsovxof(wwfkeytwyw) = cmlgwzvxhc zvppmwlhgj (sudoggyhzh, 0.69) View more
NCT03593213 (CTgov)	Phase 3	Schizophrenia	587	Placebo (Placebo (Double-blind Treatment Period))	xtsdxrizsr(xtrnlxnzui) = shbyihxmpv llwiwntmmd (iokhdyvcrg, dmfvhpvzwb - xgldcwcwmf) View more	-	08 Mar 2022
				Cariprazine (Cariprazine 3.0 mg/Day (Double-blind Treatment Period))	xtsdxrizsr(xtrnlxnzui) = ftnnxtvhmp llwiwntmmd (iokhdyvcrg, vevttfdkfe - wvppypzbnk) View more
NCT01626885 (CTgov)	Phase 2/3	Schizophrenia	42	MP-214	pdtqmplhun = tpslzhvcsc anmjblldnv (supnsfzvdv, xgqgjlyhdx - mzwwuwtibc) View more	-	13 Apr 2021
NCT01625897 (CTgov)	Phase 2/3	Chronic schizophrenia \| Schizophrenia	125	MP-214 (MP-214 1.5-9mg)	dlacaihvlu = jhozanggsq tyqadfyzic (fwqoxkeuus, xodgtgauzz - iyrrtyzpon) View more	-	13 Apr 2021
				risperidone (Risperidone 2-12mg)	dlacaihvlu = cpwycdgmtb tyqadfyzic (fwqoxkeuus, ghubzbrrce - yqgbntimlj) View more
NCT01625000 (CTgov)	Phase 2/3	Schizophrenia	512	MP-214 3mg (MP-214 3mg)	ggrqcpbpae(brtxswplnn) = mfdwsluyav czuvhfutkx (wobptsgleq, 2.0) View more	-	12 Apr 2021
				MP-214 6mg (MP-214 6mg)	ggrqcpbpae(brtxswplnn) = gspdxconox czuvhfutkx (wobptsgleq, 2.0) View more

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