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

Chengdu Kanghong Pharmaceutical Group Co., Ltd.

Chemical Works of Gedeon Richter PlcAllergan, Inc.

+ [4]

Inactive Organization

Forest Laboratories LLC

Mitsubishi Tanabe Pharma Corp.

Whan In Pharmaceutical Co., Ltd.

+ [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

CTR20253488

/ Active, not recruitingNot Applicable

QLM1016的生物等效性试验

[Translation] Bioequivalence study of QLM1016

主要研究目的研究空腹/餐后状态下单次口服受试制剂QLM1016与参比制剂盐酸卡利拉嗪胶囊（VRAYLAR ®）在健康成年参与者体内的药代动力学，评价空腹/餐后状态下口服两种制剂的生物等效性。次要研究目的研究受试制剂QLM1016和参比制剂“VRAYLAR ®”在健康参与者中的安全性。

[Translation]

Primary Study Objectives To investigate the pharmacokinetics of the test formulation, QLM1016, and the reference formulation, cariprazine hydrochloride capsules (VRAYLAR®), in healthy adult participants after a single oral dose in the fasting and fed states, and to evaluate the bioequivalence of the two formulations in the fasting and fed states. Secondary Study Objectives To investigate the safety of the test formulation, QLM1016, and the reference formulation, VRAYLAR®, in healthy participants.

Start Date04 Sep 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

NCT05060549

/ Not yet recruitingPhase 4IIT

Dopamine D3 Receptor Occupancy in Bipolar Depression by Cariprazine (Vraylar): Evaluating Its Antidepressant Benefit

Bipolar disorder is a common condition that can cause significant disability and risk for suicide. Second generation antipsychotic medications can be used to treat depression in bipolar disorder, yet we do not know how they work. Here, we will use a recently approved medication, cariprazine (Vraylar), to treat participants with bipolar depression. They will have brain imaging with PET scans before and during treatment to understand how the medication may be working. Particularly, we will look at the role of the D3 dopamine receptor.

Start Date01 Sep 2025

Sponsor / Collaborator

The New York State Psychiatric Institute

CTR20251045

/ RecruitingPhase 3

评价盐酸卡利拉嗪胶囊在精神分裂症成人患者中有效性和安全性的随机、双盲双模拟、阳性药物平行对照的多中心Ⅲ期临床试验

[Translation] A randomized, double-blind, double-dummy, positive drug parallel-controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of cariprazine hydrochloride capsules in adult patients with schizophrenia

主要目的：评价盐酸卡利拉嗪胶囊相对于阿立哌唑片在精神分裂症成人患者中的疗效。次要目的：评价盐酸卡利拉嗪胶囊相对于阿立哌唑片在精神分裂症成人患者中的安全性和耐受性。探索性目的：探索受试者对于治疗体验的主观感受。

[Translation]

Primary objective: To evaluate the efficacy of cariprazine hydrochloride capsules compared with aripiprazole tablets in adult patients with schizophrenia. Secondary objective: To evaluate the safety and tolerability of cariprazine hydrochloride capsules compared with aripiprazole tablets in adult patients with schizophrenia. Exploratory objective: To explore the subjective feelings of the subjects about the treatment experience.

Start Date11 Aug 2025

Sponsor / Collaborator

Wuhan Humanwell Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Cariprazine hydrochloride

100 Translational Medicine associated with Cariprazine hydrochloride

100 Patents (Medical) associated with Cariprazine hydrochloride

586

Literatures (Medical) associated with Cariprazine hydrochloride

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Healthcare resource utilization and costs of using cariprazine as the first versus subsequent adjunctive therapy for major depressive disorder

Article

Author: Laliberté, François ; Mahendran, Malena ; Clayton, Anita H. ; Martinez, Cristina ; Parikh, Mousam ; Masand, Prakash S. ; Nabulsi, Nadia ; Germain, Guillaume

AIM:

Inadequate response to antidepressant therapy (ADT) is common in major depressive disorder (MDD); atypical antipsychotic (AA) adjunctive therapy may be effective for these patients. This study aimed to compare healthcare resource utilization (HRU) and costs between patients initiating the AA cariprazine as their first adjunctive therapy vs those initiating cariprazine subsequently.

METHODS:

The Merative MarketScan Commercial Database (January 1, 2015, to June 30, 2021) was used to identify US adults with MDD and ≥1 pharmacy claim for cariprazine adjunctive to ADT in 2018 or after. Rates of mental health (MH)‑related and all‑cause HRU per patient-year (PPY) and mean healthcare costs per-patient-per-year (PPPY) were assessed after patients first initiated adjunctive therapy. HRU and costs were compared between cohorts using rate ratios (RRs) and mean cost differences, respectively, estimated from multivariable regression models.

RESULTS:

Of 838 patients receiving cariprazine, 44.7% initiated cariprazine as their first adjunctive therapy to ADT, and 55.3% initiated it subsequently. Those initiating cariprazine first had significantly lower rates of MH‑related hospitalizations (RR [95% confidence interval] = 0.55 [0.30, 0.90], p = .020) and outpatient (OP) visits (0.67 [0.57, 0.82], p < .001) PPY than those initiating cariprazine subsequently. Moreover, patients initiating cariprazine as their first adjunctive therapy had lower annual total MH‑related healthcare costs (mean cost difference [95% confidence interval] -$2,182 [-$4,206, -$69], p = .040), driven primarily by lower OP visit costs (-$1,511 [-$2,330, -$615], p < .001). Similar trends were observed for all-cause HRU and costs.

LIMITATIONS:

This was a retrospective analysis of secondary data with limited follow-up. Claims were a proxy for cariprazine use.

CONCLUSIONS:

Results from this real‑world study of commercially insured US adults suggest that initiating cariprazine as the first adjunctive therapy rather than a subsequent therapy could help mitigate the considerable economic burden of MDD for appropriate patients.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Real-world effectiveness of cariprazine in major depressive disorder and bipolar I disorder in the United States

Article

Author: Ta, Jamie ; McIntyre, Roger S. ; Waraich, Simranpreet ; Parikh, Mousam ; Cohen-Stavi, Chandra ; Nabulsi, Nadia ; Marci, Carl

AIMS:

The efficacy of cariprazine for major depressive disorder (MDD) (adjunctive therapy) and bipolar I (BP-I) depression has been demonstrated in clinical trials. This study evaluated the real-world effectiveness of cariprazine in reducing depression severity among patients with moderate-to-severe MDD or BP-I depression.

METHODS:

Medical/pharmacy claims and electronic medical records (EMRs) from specialty providers in the OM1 Real-World Data Cloud were used to identify adults with MDD or BP-I who initiated cariprazine (adjunctively for MDD) (first dispensing = index) and had ≥1 EMR and ≥1 claim during 12-month baseline and ≤12-month follow-up periods. Included patients had a baseline Patient Health Questionnaire (PHQ)-9 total score ≥10, reflecting at least moderate depressive symptoms. Follow-up continued until cariprazine discontinuation, alternate diagnosis (e.g. BP-I [MDD cohort] or MDD [BP-I cohort]), or 12 months post-index. Depression severity was assessed using PHQ-9 total scores that were observed or estimated from clinical notes using a previously validated machine learning algorithm. Analyses included mean change in PHQ-9 score from baseline to 2, 6, and 12 months of follow-up. A sensitivity analysis using only observed PHQ-9 scores was conducted.

RESULTS:

Of 754 patients at baseline, 396 had MDD (mean PHQ-9 = 16.4) and 358 had BP-I (mean PHQ-9 = 16.9). For patients with MDD, mean reductions in PHQ-9 scores from baseline to 2, 6, and 12 months of adjunctive cariprazine treatment were 3.5 (95% CI: 2.7, 4.4; n = 127), 4.1 (2.9, 5.4; n = 87), and 3.7 (1.6, 5.8; n = 52), respectively. For patients with BP-I, mean reductions from baseline to 2, 6, and 12 months were 5.2 (95% CI: 4.2, 6.2; n = 121), 6.5 (5.2, 7.8; n = 90), and 6.9 (5.2, 8.5; n = 54), respectively. Greater improvements were observed in the sensitivity analysis.

CONCLUSIONS:

This real-world effectiveness study of cariprazine treatment for MDD (adjunctive use) or BP-I demonstrated clinically meaningful and sustained improvement in depression symptoms during short- and long-term follow-up.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

The real-world impact of cariprazine on short- and long-term disability outcomes among commercially insured patients in the United States

Article

Author: Ta, Jamie ; Martínez, Cristina ; Laliberté, François ; Parikh, Mousam ; Lejeune, Dominique ; Zanardo, Enrico ; Nabulsi, Nadia ; Masand, Prakash S.

AIM:

To compare all-cause and mental health (MH)-related short-term and long-term disability leaves and associated costs among patients in the United States with bipolar disorder (BP), major depressive disorder (MDD), or schizophrenia spectrum disorders (SCZ) before versus after cariprazine initiation.

METHODS:

Merative MarketScan Commercial and Health and Productivity Management (HPM) databases (January 2016 to December 2021) were utilized to identify adults diagnosed with BP, MDD, or SCZ with ≥2 pharmacy cariprazine claims (first claim = index), ≥3 months of cariprazine use (adjunctively for MDD), and continuous commercial insurance coverage and HPM eligibility during baseline (12 months pre-index) and ≥3 months post-index. Observation continued until cariprazine discontinuation, insurance or HPM eligibility end, 1 year post-index, or HPM data availability end. All-cause and MH-related disability claims, days, and costs were evaluated. Baseline versus post-index rates of disability claims (events) and days were compared using rate ratios (RR); costs were compared using mean cost differences. Comparisons were calculated from generalized estimating equation models. Analyses were replicated separately across indications.

RESULTS:

There were 489 patients overall (BP = 238, MDD = 233, SCZ = 18; mean age = 43.3 years; 60.7% female; mean follow-up = 7.6 months). All-cause rates of disability events and days following cariprazine initiation were 29% (RR = 0.71 [95% CI = 0.57, 0.86]) and 28% (0.72 [0.53, 0.94]) lower than baseline, respectively (both p < .05). MH-related rates of disability events and days were 40% (0.60 [0.43, 0.80]) and 43% (0.57 [0.34, 0.84]) lower, respectively (both p < .01). All-cause disability costs were $2,917 lower and MH-related disability costs were $2,482 lower than baseline (40% and 51% decrease, respectively; both p < .01). Results were similar for indication-specific analyses.

LIMITATIONS:

Limited generalizability to patients who are unemployed, uninsured, or have public insurance.

CONCLUSIONS:

Rates of disability events, days, and mean costs were significantly lower after versus before cariprazine initiation. These results can help contextualize cariprazine's role in managing disability for these patients.

News (Medical) associated with Cariprazine hydrochloride

25 Sep 2025

·www.globenewswire.com

LB Pharmaceuticals Strengthens Board of Directors with Appointments of William Kane and Rekha Hemrajani

NEW YORK, Sept. 25, 2025 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX) today announced the appointments of William Kane and Rekha Hemrajani to its Board of Directors effective as of the pricing of its initial public offering on September 10, 2025. The Company believes Mr. Kane and Ms. Hemrajani add valuable expertise in finance, business development, product commercialization, and corporate strategy to its Board of Directors as the Company advances its lead product candidate, LB-102, into a Phase 3 clinical trial for acute schizophrenia and a Phase 2 clinical trial for bipolar depression. LB Pharmaceuticals is building a pipeline that leverages the broad therapeutic potential of LB-102, which the Company believes has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. “Ms. Hemrajani and Mr. Kane have complementary strengths that will accelerate our strategic growth as we approach the initiation of two important clinical trials early next year,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “Ms. Hemrajani’s experience in financial operations and corporate governance and Mr. Kane’s proven track record of commercializing new therapies make them outstanding additions to our Board of Directors. Their guidance will be invaluable as we work to fulfill our mission of bringing safer, more effective neuropsychiatric treatments to patients.” Mr. Kane brings over three decades of biopharmaceutical leadership to the Board. He is currently President and CEO of Uniquity Bio. He was previously President and CCO at Anthos Therapeutics (through its acquisition by Novartis), CCO at Karuna Therapeutics, where he led the commercialization strategy for Cobenfy, and held senior roles at BioXcel Therapeutics and Allergan, where he helped launch multiple leading branded therapeutics including Namzaric, Vraylar, and Ubrelvy, and at Pfizer, where he was instrumental in the success of multiple blockbuster products, including Zoloft, Zyrtec and Celebrex. He holds an MBA from The Wharton School and a B.A. in Government from Connecticut College. Mr. Kane commented, “LB Pharmaceuticals has potential to make a significant impact in neuropsychiatric care. LB‑102 offers a compelling balance of clinical activity, tolerability, and simplicity of dosing—qualities that matter deeply to prescribers and patients alike – and I look forward to supporting the Company’s efforts to deliver on this promising potential.” Ms. Hemrajani currently serves on the boards of directors of ALX Oncology, BioAge Labs, and MaxCyte. Her previous roles include CEO of Aravive, COO and CFO of Arcus Biosciences, COO of RAPT Therapeutics, and CFO of Sagimet Biosciences. She also formerly led Licensing and M&A at Onyx Pharmaceuticals (acquired by Amgen), and Business Development at Exelixis. She holds a B.S. in Economics and Computer Science from the University of Michigan and an MBA from Kellogg School of Management at Northwestern University. “I am excited to partner with LB Pharmaceuticals at this critical phase as they transition toward late-stage Phase 3 development. The data from the Phase 2 clinical trial of LB-102 provide a strong foundation for further development, and I look forward to helping guide the Company’s path toward its ultimate goal of delivering meaningful impact for patients and physicians alike.” About LB Pharmaceuticals LB Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases. About LB-102 LB-102 is a Phase 3-ready oral, small molecule and a methylated derivative of amisulpride. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. The Phase 2 trial demonstrated statistically significant benefit versus placebo at all doses studied, a potentially class leading safety profile among D2 antagonists and partial agonists, and positive effects on negative symptoms and cognition. LB-102 is advancing into a Phase 3 clinical trial for acute schizophrenia and a Phase 2 clinical trial for bipolar depression. Additional expansion opportunities for LB-102 could include major depressive disorder (MDD), predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as bipolar mania and cognitive impairment associated with schizophrenia. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102, the Company’s ability to commercialize LB-102, if approved; and continuing advancement of LB-102 and the Company’s portfolio. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in the Company’s filings with the Securities and Exchange Commission (the “SEC”) and its other documents to be subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. ContactsMedia:Michael TattoryLifeSci Communications Mtattory@lifescicomms.com Investor Relations: ir@lbpharma.us

Phase 2Executive ChangeClinical ResultPhase 3Drug Approval

18 Sep 2025

·www.globenewswire.com

Mapi Pharma Announces First Patient Recruited in Phase-I/II Study of Cariprazine Depot Once Monthly Injection

Sept. 17, 2025 -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on developing innovative long-acting depot injectable treatments, today provided an update on the clinical development program for its cariprazine once monthly injection. The company has enrolled the first patient into a Phase I/II study evaluating the product. Mapi Pharma’s injectable version of cariprazine, developed using its patented Depot technology, has demonstrated a long-acting release profile, for one monthly injection. The product is designed to address an unmet need in the treatment of schizophrenia and bipolar disorder. Cariprazine is a well-established atypical antipsychotic approved for the treatment of schizophrenia and bipolar disorder. Current formulations of cariprazine have labels that specify daily oral dosing. For these indications, however, physicians generally prefer therapeutics that have long-acting formulations. Mapi’s once-monthly injectable formulation has the potential to improve the treatment paradigm by achieving better compliance, reducing relapse risk, and simplifying disease management for patients and physicians. Ehud Marom, Chairman and Chief Executive Officer, Mapi Pharma, commented, “This is the first clinical study we are initiating as part of a series of depot products Mapi is developing. We believe that, if approved, our once-monthly injectable Cariprazine could provide a valuable new treatment option for patients with schizophrenia and bipolar disorder, with the potential to improve long term outcomes.” Mapi has constructed dedicated production facilities for Cariprazine depot. The multinational Phase I/II trial, designed to evaluate dosing-safety and efficacy, is being conducted initially in Israel with plans to add centers in other counties. The study is being funded by an upfront payment received by Mapi from an undisclosed large pharmaceutical company following a recent development agreement between the parties. The terms of the agreement include a “Go-no-Go option” for the large pharmaceutical company to advance the product into a Phase III study as part of a definitive commercial agreement that the two companies are currently negotiating. Mapi has intellectual property for its depot formulations of cariprazine that covers dose regimen from once weekly to every six months. Mapi Pharma is a clinical stage pharmaceutical company, engaged in development of high barrier-to-entry and high added-value life cycle management (“LCM”) products and AB Rated Depot injectable products that target large markets that include complex active pharmaceutical ingredients (“APIs”) and formulations. Mapi Pharma’s lead product is GA Depot which is partnered with Viatris (NASDAQ: VTRS) in an agreement under which Viatris was granted an exclusive license to commercialize the GA Depot injection product for Relapsing Forms of Multiple Sclerosis (RMS). Following successful Phase 3 results GA Depot was submitted for registration and is currently under FDA review. The Company is also marketing its own generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) in specific geographic markets. Mapi’s portfolio also includes a leading development of Depot drugs for Schizophrenia, anti-cancer, GLP-1 for diabetes, weight control, Parkinson’s disease and potentially Alzheimer’s with innovative intellectual property. Mapi is built on strong chemical and pharmaceutical R&D capabilities and a deep understanding of the global market and of regulatory needs. Mapi is a global company with a Depot R&D center, API production and aseptic Depot manufacturing and a Fill & Finish for injectable Finished Dosage Forms facilities. Mapi has strong IP positions, filing numerous patent applications for APIs and formulations. The content above comes from the network. if any infringement, please contact us to modify.

License out/inDrug Approval

31 Jul 2025

·www.fiercepharma.com

AbbVie's rumored $1B pursuit of Gilgamesh could fit into its growing neuroscience portfolio

AbbVie is looking for business development opportunities which can fuel growth "in the next decade," CEO Rob Michael said. On a day when AbbVie revealed booming sales of Skyrizi and Rinvoq and another positive adjustment to its 2025 guidance, the company also is reportedly angling to bolster its long-term prospects by way of an acquisition, according to a Bloomberg report.The Illinois pharma is discussing a potential $1 billion deal to buy out New York City psychedelic drug specialist Gilgamesh Pharmaceuticals. The companies are already partners after AbbVie paid $65 million up front and pledged $1.95 billion in potential milestones last year to help develop candidates for major depressive disorder.While AbbVie didn’t specifically address the rumored deal during a conference call on Thursday, CEO Rob Michael did discuss in general how the company is thinking about business development.“When you look at the diverse, high-growth platform we have today, that’s really going to give us the opportunity to drive top-tier performance—a clear line of sight to growth—for at least the next eight years,” Michael said. “It’s really about how we set up the company to grow beyond Skyrizi and Rinvoq.”Michael added that the company will not lose patent protection for any of its significant growth drivers for the rest of this decade, which gives AbbVie the flexibility to invest more in R&D and to continue to acquire external innovation.Evidence of this philosophy is backed up by AbbVie’s recent acquisitions, including a $2.1 billion purchase a month ago of Capstan Therapeutics, which is developing in vivo CAR-T therapies for autoimmune and other disorders. In October, AbbVie spent $1.4 billion to acquire Aliada Therapeutics and its novel Alzheimer’s disease candidate.Gaining Aliada, added to a potential acquisition of Gilgamesh, bolsters AbbVie’s already healthy neuroscience portfolio. That business increased its sales by 24% in the second quarter as each of the company’s top four products “exceeded expectations,” according to AbbVie’s chief commercial officer, Jeff Stewart.“We are fully investing in neuroscience. We look forward to maintaining our leadership position there,” Stewart said. “We’re gonna keep feeding that engine.” The engine includes mood stabilizer Vraylar, which was up 16% to $900 million in sales; therapeutic Botox, which was up 14% to $928 million; migraine treatments Ubrelvy, which jumped 47% to $338 million; plus Qulipta, which saw an increase of 77% to $267 million.As for its immunology juggernauts, AbbVie reported sales of Skyrizi at $4.4 billion, which was a 62% increase year over year, while Rinvoq topped the $2 billion mark in quarterly sales for the first time, for a 42% increase.AbbVie jacked up its 2025 revenue guidance to $60.5 billion, which is an increase of $800 million from the company’s estimate three months ago. The company has increased its Skyrizi revenue projection by $600 million to $17.1 billion for the year, while decreasing its estimate for fading powerhouse Humira by $500 million to $3 billion for the year, “reflecting biosimilar competition,” CFO Scott Reents said. AbbVie did not adjust its 2027 projection of $31 billion for combined Skyrizi and Rinvoq sales, even though the products are tracking to exceed the figure. “We will update that at the appropriate time, but momentum is clearly there,” Michael said, adding that the company typically adjusts long-term guidance at the end of the year, often unveiling adjustments at the J.P. Morgan conference in January.As for its neuroscience portfolio, AbbVie has added $300 million, putting its projection for the year at $10.5 billion, which includes a $100 million increase for Parkinson’s disease drug Vyalev, which was approved in October of last year and generated $98 million in the second quarter, “reflecting strong international uptake,” Reents said.

Acquisition

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
Heart Septal Defects, Atrial	Phase 3	Puerto Rico	AbbVie, Inc.	07 Jul 2022
Irritable Mood	Phase 3	United States	AbbVie, Inc.	07 Jul 2022
Irritable Mood	Phase 3	Puerto Rico	AbbVie, Inc.	07 Jul 2022
Acute schizophrenia	Phase 3	United States	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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Schizophrenia	116	cariprazine (women outpatients)	wkajhwrhvy(uieamxndjr) = 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. vnsrnugnbl (ubekrevoad )	Positive	18 Oct 2023
NCT03573297 (CTgov)	Phase 3	Mania \| Depressive Disorder \| Bipolar I disorder	901	placebo (Double-Blind Placebo QD)	ovcwsdresm(jtvvmsalsb) = zivrwfzczu wbevzflkzs (yrthxnamdh, jikbieuqhi - tnsxjiuafd) View more	-	28 Sep 2023
				Cariprazine (Double-Blind Cariprazine 1.5 mg QD)	ovcwsdresm(jtvvmsalsb) = znztfwjvsh wbevzflkzs (yrthxnamdh, gcvkwmbeqx - fiecnackgj) View more
NCT03738215 (Pubmed \| Am J Psychiatry)	Phase 3	Depressive Disorder, Major	751	Placebo	qpqwulytvw(hyjrudtlfz) = gazhnjntej rdkzrbyvdj (uxwmujxzpo )	Positive	15 Feb 2023
				Cariprazine 1.5 mg/day	qpqwulytvw(hyjrudtlfz) = kpryuencbd rdkzrbyvdj (uxwmujxzpo )
NCT03738215 (CTgov)	Phase 3	Depressive Disorder, Major	759	Placebo (Placebo + ADT)	puoxnmdmcg(anpjisnpvf) = fihjrbpibk nssdvogemj (kaubccqbki, 0.70) View more	-	25 Oct 2022
				Cariprazine (Cariprazine 1.5 mg/Day + ADT)	puoxnmdmcg(anpjisnpvf) = wnoxfufuqn nssdvogemj (kaubccqbki, 0.70) View more
NCT03739203 (CTgov)	Phase 3	Depressive Disorder, Major	752	Placebo+ADT (Placebo + ADT)	prnphenpiz(bphlyoodmc) = ytjpaqbpou usahaqyksi (pwddewzhip, 0.70) View more	-	21 Sep 2022
				ADT+Cariprazine (Cariprazine 1.5 mg/Day + ADT)	prnphenpiz(bphlyoodmc) = pxvfoqwjqo usahaqyksi (pwddewzhip, 0.69) View more
NCT03593213 (CTgov)	Phase 3	Schizophrenia	587	Placebo (Placebo (Double-blind Treatment Period))	rrfvtnktdz(dgsgrmcfas) = dkvhvexdtx rrhconxdvb (btdekgchcx, vkjutqzthm - apemzipave) View more	-	08 Mar 2022
				Cariprazine (Cariprazine 3.0 mg/Day (Double-blind Treatment Period))	rrfvtnktdz(dgsgrmcfas) = sfmtnolbuq rrhconxdvb (btdekgchcx, picnnzvpcq - makkwjjzjd) View more
NCT01626885 (CTgov)	Phase 2/3	Schizophrenia	42	MP-214	ifeyghjfbt = vbpsprbggy iecgvmtuok (ulfbveqisi, pgqvwetuwk - wmommkobhv) View more	-	13 Apr 2021
NCT01625897 (CTgov)	Phase 2/3	Chronic schizophrenia \| Schizophrenia	125	MP-214 (MP-214 1.5-9mg)	xpdlroxbsg = lpcvlgeeej ccopyosjwr (hmeuhvczvh, vqcvmkpcli - cypmtgdkig) View more	-	13 Apr 2021
				risperidone (Risperidone 2-12mg)	xpdlroxbsg = jckgnvgcbu ccopyosjwr (hmeuhvczvh, wforpycivv - lcrsppxqww) View more
NCT01626872 (CTgov)	Phase 2/3	Schizophrenia	254	MP-214 3mg (MP-214 3mg)	xwdtxtdety = weetsxomkp symrlbmwmi (bwpvvjjmxx, zubcwlovrw - zejdunpzej) View more	-	12 Apr 2021
				MP-214 6mg (MP-214 6mg)	xwdtxtdety = mgdyuhsaiu symrlbmwmi (bwpvvjjmxx, fndhwlzbme - bfrpqcdwdc) View more
NCT00862992 (CTgov)	Phase 2	Schizophrenia	34	Cariprazine (Cariprazine 3 mg)	rdkoyyktgm = fxvxzpwktd cuqrmsbsvc (fyflakxcra, qtcwjetdad - afrkdejvrb) View more	-	12 Apr 2021
				Cariprazine (Cariprazine 6 mg)	rdkoyyktgm = mtvzygmcfb cuqrmsbsvc (fyflakxcra, elcerlicux - dhsvhfsuii) View more

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