Drugs / Aripiprazole
Aripiprazole
also known as
Abilify · OPC-14597 · Abilify Maintena · AOM · APZ · AOM 400 · aripiprazole once-monthly · Aripiprazole: Abilify · +22 more
Other / unclassified targets DRD2, HTR1A, HTR2A via activation / inhibition
Regulatory milestones approvals, filings & regulatory actions · 27 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed autism spectrum disorder 1 1 milestone | |||||
| Filed | US (FDA) | ABILIFY | autism spectrum disorder 1 | 2009-04-28 | “submitted a supplemental NDA for ABILIFY® to the FDA for treatment of irritability associated with autistic disorder” bms.com ↗ |
| Filed bipolar disorder 1 milestone | |||||
| Filed | Japan (PMDA) | ABILIFY | bipolar disorder | 2011-01-24 | “has applied for additional indication regulatory approval in Japan for ABILIFY (aripiprazole), a treatment for the manic symptoms associated with bipolar disorder.” otsuka.co.jp ↗ |
| Filed bipolar I disorder 5 milestones | |||||
| Filed | US (FDA) | — | bipolar I disorder | 2022-09-13 | “Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) acceptance of their New Drug Application (NDA) for aripiprazole 2-month” lundbeck.com ↗ “Aripiprazole 2-month, ready-to-use, long-acting injectable has been filed for approval in Europe, Canada and the United States.” otsuka-us.com ↗ |
| Filed | US (FDA) | ABILIFY | bipolar I disorder | 2017-05-23 | “FDA has acknowledged receipt of the New Drug Application (NDA) resubmission for the drug-device combination product of ABILIFY® (aripiprazole)” otsuka-us.com ↗ |
| Filed | US (FDA) | ABILIFY MAINTENA | bipolar I disorder | 2016-11-30 | “ABILIFY MAINTENA® for the maintenance treatment of bipolar I disorder in adult patients is sufficiently complete to permit a substantive review and is considered filed.” otsuka-us.com ↗ |
| Rejected (CRL) | US (FDA) | — | bipolar I disorder | 2016-04-26 | “FDA has issued a Complete Response Letter (CRL) for their Digital Medicine, a drug/device combination product, which combines Otsuka's ABILIFY® (aripiprazole)” otsuka-us.com ↗ “FDA has issued a Complete Response Letter (CRL) for their Digital Medicine, a drug/device combination product, which combines Otsuka’s ABILIFY® (aripiprazole)” otsuka-us.com ↗ |
| Filed | US (FDA) | — | bipolar I disorder | 2015-09-08 | “This is the first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within the medication tablet.” otsuka-us.com ↗ “This is the first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within the medication tablet” otsuka-us.com ↗ |
| Filed schizophrenia 5 milestones | |||||
| Filed | EU (EMA) | — | schizophrenia | 2022-06-17 | “EMA has accepted the Marketing Authorisation Application (MAA) for aripiprazole as a 2-month ready-to-use (RTU) long-acting injectable (LAI)” otsuka.co.jp ↗ “Aripiprazole 2-month, ready-to-use, long-acting injectable has been filed for approval in Europe, Canada and the United States.” otsuka-us.com ↗ |
| Filed | US (FDA) | Abilify Maintena | schizophrenia | 2014-12-15 | “the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for a proposed new injection site—the deltoid muscle of the...” otsuka-us.com ↗ |
| Filed | US (FDA) | Abilify Maintena | schizophrenia | 2014-04-30 | “Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the proposed expanded labeling of Abilify Maintena (aripiprazole)” otsuka-us.com ↗ |
| Filed | Japan (PMDA) | — | schizophrenia | 2014-01-15 | “today announced it filed an application with the Pharmaceutical and Medical Devices Agency (PMDA) in Japan to market Aripiprazole Extended Release Injectable” otsuka.co.jp ↗ |
| Filed | EU (EMA) | Abilify Maintena | schizophrenia | 2012-12-21 | “announced the European Medicines Agency's (EMA) acceptance of the submission of a marketing authorisation application (MAA) for the approval of aripiprazole depot formulation” otsuka.co.jp ↗ “Marketing Authorization Application (MAA) for ABILIFY MAINTENA submitted in Europe in December 2012.” otsuka.co.jp ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansion | US (FDA) | ABILIFY ASIMTUFII | — | 2025-03-28 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | ABILIFY MAINTENA KIT | — | 2014-12-05 – 2017-07-27 | fda.gov ↗ |
| Label expansions (9) | US (FDA) | ABILIFY | — | 2003-08-28 – 2014-06-09 | fda.gov ↗ |
| Approved | EU (EMA) | Abilify | — | 2004-06-04 | europa.eu ↗ |
| Approved | US (FDA) | ABILIFY | — | 2002-11-15 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 65
| Date | Issuer | Release |
|---|---|---|
| 2024-03-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Abilify Maintena 960mg (aripiprazole) approved in the EU as the first once-every-two-months long-acting injectable for the maintenance treatment of schizophrenia® otsuka.co.jp ↗
We welcome the EC approval of aripiprazole once-every-two-months LAI, which represents a significant milestone in offering adult patients with schizophrenia another, simplified, treatment regimen. |
| 2024-03-19 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Aripiprazole Tablets, USP lupin.com ↗
Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) |
| 2023-04-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Approves Otsuka and Lundbeck's ABILIFY ASIMTUFII(aripiprazole), the First, Two-month, Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults® otsuka.co.jp ↗ |
| 2023-04-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Approves Otsuka and Lundbeck’s ABILIFY ASIMTUFII® (aripiprazole), the First Once-Every-Two-Months Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults otsuka-us.com ↗ |
| 2023-04-27 | H. Lundbeck A/S | Regulatory FDA Approves Otsuka and Lundbeck’s ABILIFY ASIMTUFII® (aripiprazole), the First Once-Every-Two-Months Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults lundbeck.com ↗ |
| 2023-04-13 | H. Lundbeck A/S | Results Otsuka and Lundbeck Published Study Results Showing Aripiprazole 2-Month, Ready-to-Use, Long-Acting Injectable is as Well-Tolerated, and Provides Similar Plasma Levels as Aripiprazole 1-Month for Treatment of Schizophrenia and Bipolar I Disorder lundbeck.com ↗
Results showed aripiprazole 2-month is a well-tolerated maintenance treatment for schizophrenia and BP-I and maintains consistent therapeutic plasma levels for at least two months as compared to aripiprazole 1-month plasma levels following repeated monthly dosing. |
| 2023-04-04 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka and Lundbeck Published Study Results Showing Aripiprazole 2-Month, Ready-to-Use, Long-Acting Injectable is as Well-Tolerated, and Provides Similar Plasma Levels as Aripiprazole 1-Month for Treatment of Schizophrenia and Bipolar I Disorder otsuka-us.com ↗
Results showed aripiprazole 2-month is a well-tolerated maintenance treatment for schizophrenia and BP-I and maintains consistent therapeutic plasma levels for at least two months as compared to aripiprazole 1-month plasma levels following repeated monthly dosing. |
| 2022-09-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application forAripiprazole 2-month, Ready-to-Use, Long-acting Injectable to Treat Schizophrenia andBipolar I Disorder in Adults otsuka.co.jp ↗ |
| 2022-09-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application for Aripiprazole 2-month, Ready-to-Use, Long-acting Injectable to Treat Schizophrenia and Bipolar I Disorder in Adults otsuka-us.com ↗ |
| 2022-09-13 | H. Lundbeck A/S | Regulatory Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application for Aripiprazole 2-month, Ready-to-Use, Long-acting Injectable to Treat Schizophrenia and Bipolar I Disorder in Adults lundbeck.com ↗
Otsuka America Pharmaceutical, Inc., (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) acceptance of their New Drug Application (NDA) for aripiprazole 2-month, ready-to-use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults. |
| 2022-06-17 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory European Medicines Agency Commences Review of Aripiprazole2-Month Long-Acting Injectable for the Maintenance Treatment of Schizophrenia in Adult Patients Stabilised with Aripiprazole otsuka.co.jp ↗
LONDON, UK, 16 June 2022 - Otsuka Pharmaceutical Europe Ltd. ("Otsuka") and H. Lundbeck A/S ("Lundbeck") today announce that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for aripiprazole as a 2-month ready-to-use (RTU) long-acting injectable (LAI) for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole. |
| 2020-09-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka's ABILIFY MAINTENA approved for the additional indication of bipolar I disorder in Japan otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. announces that it has received regulatory approval in Japan for the additional indication of suppression of recurrence and relapse of mood episodes in bipolar I disorder for ABILIFY MAINTENA (aripiprazole), a long-acting injectable suspension. |
| 2019-09-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Applies for the Additional Indication in Japan of Bipolar Disorder for ABILIFY MAINTENA for Suspended Release Injectable Suspension otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. announces that it has filed an application in Japan for the additional indication of suppression of recurrence and relapse of mood episodes in bipolar disorder for ABILIFY MAINTENA (aripiprazole), a long-acting injectable suspension. |
| 2019-03-06 | Upsher-Smith Laboratories | Regulatory MHLW Approves New Indication for ARIPIPRAZOLE Tablets and Oral Solution upsher-smith.com ↗ |
| 2018-09-05 | Upsher-Smith Laboratories | Regulatory MHLW Approves New Indication for ARIPIPRAZOLE Tablets 3 mg / 6 mg / 12 mg / 24 mg [SAWAI] and ARIPIPRAZOLE Oral Solution 3 mg / 6 mg / 12 mg Packet [SAWAI] upsher-smith.com ↗ |
| 2018-08-30 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for two products, Gemfibrozil Tablets USP and Aripiprazole Orally Disintegrating Tablets USP zyduslife.com ↗
Zydus receives final approval from the USFDA for two products, Gemfibrozil Tablets USP and Aripiprazole Orally Disintegrating Tablets USP |
| 2017-11-14 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka and Proteus Announce the First U.S. FDA Approval of a Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor) otsuka.co.jp ↗
Only functions of the app related to tracking drug ingestion have been approved by the FDA. |
| 2017-11-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka And Proteus® Announce The First U.S. FDA Approval of A Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor) otsuka-us.com ↗ |
| 2017-07-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory ABILIFY MAINTENA® (aripiprazole) for Extended-Release Injectable Suspension Approved by U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension was approved by the U.S. Food and Drug Administration for the maintenance monotherapy treatment of bipolar I disorder (BP I) in adults.*1 |
| 2017-07-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Submits New Drug Application in Japan for Aripiprazole Sertraline Combination Tablets otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. today announced the submission of an application for the manufacture and marketing approval in Japan of the aripiprazole sertraline combination tablet, development code ASC-01. |
| 2017-07-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory ABILIFY MAINTENA® (Aripiprazole) for Extended-Release Injectable Suspension Approved by U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder otsuka-us.com ↗
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S today announced ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension was approved by the U.S. Food and Drug Administration for the maintenance monotherapy treatment of bipolar I disorder (BP‑I) in adults. |
| 2017-05-23 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka and Proteus Digital Heath Resubmit Application to US FDA for First Digital Medicine otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announce that the United States Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for the drug-device combination product of ABILIFY® (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. |
| 2016-12-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka and Lundbeck Present Data At ACNP Annual Meeting On Long-Acting Injectable Aripiprazole As A Potential Maintenance Treatment For Bipolar I Disorder otsuka-us.com ↗
Study data demonstrate that ABILIFY MAINTENA delayed time to recurrence of mood episodes in adult patients1. |
| 2016-12-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Accepts For Review A Supplemental New Drug Application To Expand Labeling Of Abilify Maintena® (aripiprazole) For The Treatment Of Bipolar I Disorder otsuka.co.jp ↗ |
| 2016-11-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Accepts For Review A Supplemental New Drug Application To Expand Labeling Of ABILIFY MAINTENA® (aripiprazole) For The Treatment Of Bipolar I Disorder otsuka-us.com ↗
the supplemental New Drug Application (sNDA) for the expanded labeling of ABILIFY MAINTENA® for the maintenance treatment of bipolar I disorder in adult patients is sufficiently complete to permit a substantive review and is considered filed. |
| 2016-09-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Antipsychotic ABILIFY Gains Approval in Japan for the Additional Indication of Irritability Associated with Pediatric Autism Spectrum Disorder otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. on September 28, 2016 obtained regulatory approval in Japan of the antipsychotic drug ABILIFY tablet (generic name aripiprazole) for the additional indication of irritability associated with pediatric autistic spectrum. |
| 2016-04-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Issues Complete Response Letter For Digital Medicine New Drug Application otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announced that the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for their Digital Medicine, a drug/device combination product, which combines Otsuka's ABILIFY® (aripiprazole), an atypical antipsychotic, with the FDA-cleared Proteus ingestible sensor embedded in a single tablet at point of manufacture. |
| 2016-04-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Issues Complete Response Letter For Digital Medicine New Drug Application otsuka-us.com ↗
FDA has completed its review and has requested additional information, including data regarding the performance of the product under the conditions in which it is likely to be used, and further human factors investigations. |
| 2016-03-02 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory ABILIFY for Extended Release Injectable Suspension, Used to treat Schizophrenia, Has Received Approval in Japan for Administration at Deltoid Muscle Site otsuka.co.jp ↗
Henceforth, it will be possible to administer treatment in an intramuscular area of the upper arm, the deltoid triangular muscle. |
| 2015-12-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Files for Approval in Japan for an Additional Indication for the Antipsychotic ABILIFY: Excitability Associated with Juvenile Autism otsuka.co.jp ↗
An application has been filed with regulatory authorities in Japan for the approval of an additional indication for the antipsychotic ABILIFY, which has been prescribed in Japan since 2006. |
| 2015-09-11 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health otsuka.co.jp ↗
the New Drug Application (NDA) for the combination product of ABILIFY® (aripiprazole) embedded with a Proteus® ingestible sensor in a single tablet is sufficiently complete to allow for a substantive review and is considered filed as of September 8, 2015. |
| 2015-09-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health otsuka-us.com ↗ |
| 2015-08-18 | Lannett Company, Inc. | Regulatory Lannett Receives FDA Approval, Launches Generic Antidepressant Drug ABILIFY® investorroom.com ↗ |
| 2015-07-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Approves Deltoid Injection Site for Abilify Maintena® (aripiprazole) for extended-release injectable suspension in the Treatment of Schizophrenia otsuka-us.com ↗ |
| 2015-03-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Pre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole) Prolonged-Release Suspension for Injection, Used in the Treatment of Schizophrenia, Received Positive CHMP Opinion (Approval in EU) otsuka.co.jp ↗
CHMP positive opinion (approval in EU) of the dual chamber kit follows the recent approval of the deltoid muscle as a new injection site for Abilify Maintena, the latter approval providing patients with a wider range of treatment options. |
| 2015-03-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Granted Approval in Japan for a New Formulation of ABIILIFY - ABILIFY for Extended-release Injectable Suspension, for Intramuscular Use - Indicated for Schizophrenia otsuka.co.jp ↗
Based on its demonstrated efficacy ABILIFY has received regulatory approval in Japan for the manufacture and marketing of ABILIFY in 300 mg and 400 mg vials and in 300 mg and 400 mg dual-chamber syringes. |
| 2014-12-15 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory U.S. FDA Accepts for Review Supplemental New Drug Application for Deltoid Administration of Abilify Maintena® (aripiprazole) Extended-Release Injectable Suspension otsuka-us.com ↗
Otsuka America Pharmaceutical, Inc. (OAPI) and Lundbeck today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for a proposed new injection site—the deltoid muscle of the arm—for Abilify Maintena® (aripiprazole) for extended-release injectable suspension. |
| 2014-12-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory U.S. FDA Approves The Labeling Update Of Abilify Maintena (Aripiprazole) For Extended-Release Injectable Suspension To Describe New Clinical Data For The Treatment Of Acutely Relapsed Adults With Schizophrenia ® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that the U.S. Food and Drug Administration (FDA) approved the labeling update of Abilify Maintena® (aripiprazole) for extended-release injectable suspension. |
| 2014-11-03 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Aripiprazole Once-Monthly Injectable Shows Superior Effectiveness to Paliperidone Palmitate Once-Monthly Injectable on Quality of Life Scale in Patients with Schizophrenia otsuka-us.com ↗
Patients treated with aripiprazole once-monthly demonstrated a statistically significant improvement on the primary endpoint, quality-of-life measures, compared to those treated with paliperidone palmitate |
| 2014-09-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory U.S. FDA Approves Dual-Chamber Syringe for Abilify Maintena® (aripiprazole) Extended-Release Injectable Suspension for the Treatment of Schizophrenia otsuka-us.com ↗
Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck announced today that the U.S. Food and Drug Administration (FDA) has approved a new formulation of Abilify Maintena® (aripiprazole) for extended-release injectable suspension – a pre-filled dual-chamber syringe. |
| 2014-04-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Accepts For Review Otsuka Pharmaceutical And Lundbeck's Supplemental New Drug Application To Expand Abilify Maintena ® (Aripiprazole) Labeling otsuka-us.com ↗
Otsuka America Pharmaceutical, Inc. (OAPI) and H.Lundbeck A/S (Lundbeck) today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the proposed expanded labeling of Abilify Maintena (aripiprazole) for extended-release injectable suspension to support broader use of the drug for treatment of patients in the acute phase of schizophrenia. |
| 2014-02-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka and Lundbeck Announce Once-Monthly Abilify Maintena™ Approved in Canada for the Maintenance Treatment of Schizophrenia in Stabilized Adult Patients otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced Health Canada's issuance of a Notice of Compliance for ABILIFY MAINTENA™, an intramuscular (IM) once-monthly injectable formulation indicated for the maintenance treatment of schizophrenia in stabilized adult patients. |
| 2014-01-15 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Pharmaceutical Submits Marketing Authorization Application in Japan for Abilify Once-Monthly Injectable Form for the Treatment of Schizophrenia otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. today announced it filed an application with the Pharmaceutical and Medical Devices Agency (PMDA) in Japan to market Aripiprazole Extended Release Injectable, a once-monthly formulation of Abilify, for the treatment of schizophrenia. |
| 2013-11-21 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka and Lundbeck's Once-Monthly Abilify Maintena® (Aripiprazole) Now Approved in Europe for Maintenance Treatment of Schizophrenia in Adult Patients Stabilized with Oral Aripiprazole otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced marketing authorization approval from the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. |
| 2013-09-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka And Lundbeck Receive Postive Chmp Opinion In Europe For Abilify Maintena, A Once-Monthly Injectable For Schizophrenia™ otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation indicated for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. |
| 2013-06-14 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory A New Choice of Therapy for the Treatment of Depression:ABILIFY® Granted Additional Approval as Adjunctive Therapy for the Treatment of Depression in Japan otsuka.co.jp ↗
ABILIFY for depression/depressive state is the third indication approved in Japan. |
| 2013-05-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Study Shows Effects of Treatment with ABILIFY MAINTENA™ (Aripiprazole) on Psychiatric Hospitalization Rates for Patients with Schizophrenia otsuka.co.jp ↗
Results suggested that total psychiatric hospitalization rates in the prospective study period for ABILIFY MAINTENA were significantly reduced compared to hospitalization rates in the retrospective period when patients received oral antipsychotics (p<0.0001)*1 |
| 2013-03-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Approves Once-Monthly ABILIFY MAINTENA™ (Aripiprazole) For Extended-Release Injectable Suspension for the Treatment of Schizophrenia otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA™ (aripiprazole) for extended-release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia. |
| 2013-02-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory The European Medicines Agency (EMA) Approves Aripiprazole (ABILIFY®) for the Treatment of Moderate to Severe Manic Episodes in Bipolar I Disorder in Adolescents. otsuka.co.jp ↗
Otsuka Pharmaceutical Co. Ltd. announced today that the European Medicines Agency (EMA) has approved a label extension for aripiprazole for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 and older. |
| 2012-12-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka and Lundbeck initiate the regulatory process for aripiprazole (once-monthly) depot formulation in Europe otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the European Medicines Agency's (EMA) acceptance of the submission of a marketing authorisation application (MAA) for the approval of aripiprazole depot formulation. |
| 2012-09-03 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory ABILIFY® ,The First Antipsychotic Agent in Japan Applying for Adjunctive Treatment in Major Depressive Disorder otsuka.co.jp ↗
Otsuka Pharmaceutical, leading the global research & development in the Central Nervous System domain, has filed for additional indication as adjunctive therapy for major depressive disorder, the first such indication for antipsychotic drugs in Japan |
| 2012-05-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Results from a Phase 3 Study of Once-monthly Aripiprazole Intramuscular (IM) Depot Formulation for the Maintenance Treatment of Schizophrenia Presented at APA Annual Meeting otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia. |
| 2012-01-18 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Antipsychotic Agent ABILIFY® Receives Regulatory Approvals for Additional Indication "Improvement of Manic Symptoms Associated with Bipolar Disorder" and for New Dosage Form "ABILIFY® OD Tablets" otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) has received new regulatory approvals in Japan for the antipsychotic agent ABILIFY® (aripiprazole). |
| 2011-11-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory New Drug Application for Otsuka's Once-monthly Aripiprazole Depot Formulation for Maitenance Treatment of Adult Patients With Schizophrenia Accepted for Review by the U.S. Food and Drug Administration otsuka.co.jp ↗ |
| 2011-02-18 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory ABILIFY (aripiprazole) Approved for Maintenance Treatment of Bipolar I Disorder as an Adjunct to Either Lithium or ValproateData from 52-week maintenance trial showed superiority of adjunctive ABILIFY versus adjunctive placebo on primary study endpoint® otsuka.co.jp ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd., announced today that the U.S. Food and Drug Administration (FDA) has approved ABILIFY (aripiprazole) as an adjunct to the mood stabilizers lithium or valproate for the maintenance treatment of Bipolar I Disorder. |
| 2011-02-17 | Bristol-Myers Squibb | Regulatory ABILIFY® (aripiprazole) Approved for Maintenance Treatment of Bipolar I Disorder as an Adjunct to Either Lithium or Valproate bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. , announced today that the U.S. Food and Drug Administration (FDA) has approved ABILIFY ® (aripiprazole) as an adjunct to the mood stabilizers lithium or valproate for the maintenance treatment of Bipolar I Disorder. |
| 2011-01-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Pharmaceutical Files for Additional Indication Regulatory Approval in Japan for ABILIFY, a Treatment for the Manic Symptoms Associated with Bipolar Disorder® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. today announced that it has applied for additional indication regulatory approval in Japan for ABILIFY (aripiprazole), a treatment for the manic symptoms associated with bipolar disorder. |
| 2010-10-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results OTSUKA ANNOUNCES PHASE 3 ARIPIPRAZOLE INTRAMUSCULAR (IM) DEPOT TRIAL INTERIM ANALYSIS REVEALS EFFICACY CRITERIA MET otsuka.co.jp ↗
This is due to the study successfully meeting efficacy criteria at a protocol-specified interim analysis. |
| 2009-11-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory U.S. Food and Drug Administration Approves ABILIFY (aripiprazole) for the Treatment of Irritability Associated with Autistic Disorder in Pediatric Patients (Ages 6 to 17 Years)® otsuka.co.jp ↗ |
| 2009-11-20 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves ABILIFY® (aripiprazole) for the Treatment of Irritability Associated with Autistic Disorder in Pediatric Patients (Ages 6 to 17 Years) bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY ® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. |
| 2008-05-08 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Add-On Treatment to Lithium or Valproate in the Acute Treatment of Adults With Manic and Mixed Episodes of Bipolar I Disorder With or Without Psychotic Features bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved updated labeling for ABILIFY ® (aripiprazole) as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults. |
| 2008-05-08 | Bristol-Myers Squibb | Regulatory ABILIFY(R) (aripiprazole) Receives Expanded Indications for Maintenance Treatment in Both Pediatric Patients (Aged 10-17) With Manic and Mixed Episodes of Bipolar I Disorder and Adolescents (Aged 13-17) With Schizophrenia bms.com ↗
Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced that ABILIFY ® (aripiprazole) received expanded indications in Bipolar I Disorder and Schizophrenia. |
| 2008-02-29 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves ABILIFY® (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated with Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age) bms.com ↗
Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY® (aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old). |
| 2007-11-09 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory U.S. FOOD AND DRUG ADMINISTRATION APPROVES ABILIFY (aripiprazole) AS THE FIRST MEDICATION FOR ADD-ON TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)® otsuka.co.jp ↗
ABILIFY is the first medication approved by the FDA as add-on treatment for MDD. |
| 2006-01-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka's Antipsychotic Abilify Is Approved in Japan, January 23, 2006® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka; Head Office: Chiyoda-ku, Tokyo; President: Tatsuo Higuchi; Tel: +81-3-3292-0021) received approval in Japan on January 23, 2006, for its atypical antipsychotic Abilify (code name: OPC-14597; generic name: aripiprazole). |
All press releases naming this drug 89 releases
Evidence & citations 38 cited values
Every value below carries the sentence it was read from. 383 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | aripiprazole | “Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol...” NCT01323205 ↗370“Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine,...” NCT01765829 ↗ “Work in a rodent relapse model has demonstrated that the atypical neuroleptic drug aripiprazole (Abilify), a partial agonist at dopamine D2 receptors, can block relapse to...” NCT00780702 ↗ “Subjects will be switched to Abilify Maintena (Aripiprazole) LAI monthly doses of 400mg, 300mg, 200mg or 160mg and have their sexual functioning reevaluated over a 3 month...” NCT02472652 ↗ “All the eligible participants will be randomly assigned to an oral atypical antipsychotic (risperidone, olanzapine, quetiapine, and where commercially available, aripiprazole...” NCT00256997 ↗ “Patients randomized to oral comparator arm will receive oral antipsychotics (haloperidol, paliperidone ER, risperidone, olanzapine, quetiapine or aripiprazole) as per...” NCT01081769 ↗ “Concomitant therapy with antipsychotic medication (aripiprazole \[10 to 30 mg/day\], olanzapine \[10 to 20 mg/day\], paliperidone \[3 to 12 mg/day\], or risperidone \[2 to 16 mg/day\])” NCT01556763 ↗ “Oral Abilify (aripiprazole) is effective in the treatment of patients with BD when prescribed as an acute anti-manic agent and for the maintenance treatment of bipolar disorder.” NCT03408873 ↗ “TAU patients will continue receiving care as recommended by their physician which will include the use of Aripiprazole according to the approved labels.” NCT03881449 ↗ “United States (U.S.) label prescribed dose of one of the following Standard of Care Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine)” NCT01052103 ↗ “Including Olanzapine, Risperidone, Paliperidone, Quetiapine, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine, and all Typical antipsychotics” NCT05741502 ↗ |
| Known as | Abilify | “Work in a rodent relapse model has demonstrated that the atypical neuroleptic drug aripiprazole (Abilify), a partial agonist at dopamine D2 receptors, can block relapse to...” NCT00780702 ↗16“Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with...” NCT00288366 ↗ “This is an investigator-initiated study whose primary aim is to determine the effectiveness of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current...” NCT00221416 ↗ “Oral Abilify (aripiprazole) is effective in the treatment of patients with BD when prescribed as an acute anti-manic agent and for the maintenance treatment of bipolar disorder.” NCT03408873 ↗ “use of aripiprazole (Abilify) in patients with alcohol and/or drug dependence with comorbid psychiatric conditions” NCT00208169 ↗ “Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)” NCT00221962 ↗ “Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia (BMS)” NCT00211302 ↗ “The newest antipsychotic medication to be FDA approved is Aripiprazole (Abilify).” NCT00174876 ↗ “receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM” NCT02237417 ↗ “Aripiprazole (Abilify®) IM Depot Injection” NCT01432444 ↗ “aripiprazole (Abilify)” NCT00181779 ↗ |
| Known as | Abilify asimtufii | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | Abilify Maintena | “Abilify Maintena is an intramuscular (IM) depot formulation of oral aripiprazole (Abilify).” NCT03408873 ↗ |
| Known as | Abilify maintena kit | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | ABILIFY MYCITE | “This is a 12 month, pragmatic trial designed to assess the differences in a digital medicine system (DMS)- ABILIFY MYCITE (Aripiprazole tablets with sensor)- measuring...” NCT03881449 ↗ |
| Known as | Abilify mycite kit | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | Ablify | “Olanzapine (Zyprexa), Quetiapine (Seroquel), Ziprasidone (Geodon), Aripiprazole (Ablify)” NCT00177164 ↗ |
| Known as | AOM | “OBJECTIVE: To evaluate aripiprazole once-monthly (AOM), a long-acting injectable suspension of aripiprazole, as acute treatment in patients with schizophrenia (DSM-IV-TR).” PMID 25188501 ↗ Nov 20142“The present study aimed to evaluate the efficacy and safety of aripiprazole once-monthly (AOM) compared to oral aripiprazole in treating acute schizophrenia.” PMID 34989824 ↗ Jan 2022 “Aripiprazole once-monthly (AOM), a long-acting injectable antipsychotic, is increasingly used in managing schizophrenia.” PMID 41034820 ↗ Oct 2025 |
| Known as | AOM 400 | “OBJECTIVE: To evaluate efficacy, safety, and tolerability of long-acting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) as maintenance treatment for...” PMID 28146613 ↗ Mar 20171“The long-acting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) was recently approved for maintenance treatment of bipolar I disorder (BP-I).” PMID 29886522 ↗ Jun 2018 |
| Known as | APZ | “OBJECTIVE: To examine the effectiveness and cognitive effects of aripiprazole (APZ) in children with a primary diagnosis of attention-deficit/hyperactivity disorder (ADHD).” PMID 18759644 ↗ Aug 20082“Therefore, this study aimed to investigate the effectiveness of adjuvant of aripiprazole (APZ) to MPH in patients with comorbid ADHD and DMDD.” NCT03358277 ↗ “Aripiprazole (APZ), effects dopamine and serotonin receptors with fewer limiting side effects seen with other atypical antipsychotics.” NCT00884884 ↗ |
| Known as | ARI | “Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)” NCT01742390 ↗ |
| Known as | ARI-OM | “The aim of this study was to evaluate the safety and tolerability of aripiprazole once-monthly (ARI-OM) for the maintenance treatment of schizophrenia.” PMID 23615694 ↗ Jul 2013 |
| Known as | Aripiprazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | Aripiprazole (extended-release injectable suspension): Abilify Maintena | “Aripiprazole (extended-release injectable suspension): Abilify Maintena®” NCT01795547 ↗ |
| Known as | Aripiprazole accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | Aripiprazole mylan pharma (previously aripiprazole pharmathen) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | aripiprazole once-monthly | “BACKGROUND: QUALIFY was a 28-week, randomized, open-label, head-to-head trial that assessed improvements across multiple measures in stable patients with schizophrenia with...” PMID 27927736 ↗ Jan 20171“Efficacy and safety of aripiprazole once-monthly versus oral aripiprazole in Chinese patients with acute schizophrenia: a multicenter, randomized, double-blind, non-inferiority study.” PMID 34989824 ↗ Jan 2022 |
| Known as | Aripiprazole sandoz | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | Aripiprazole zentiva | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | Aripiprazole: Abilify | “Aripiprazole: Abilify®” NCT01795547 ↗1“Aripiprazole (Abilify)” NCT00567099 ↗ |
| Known as | Aripiprex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | AZP | “12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)” NCT00223496 ↗ |
| Known as | BMS-337039 | “Aripiprazole (BMS-337039)” NCT01438060 ↗ |
| Known as | Lu AF41155 | “Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia” NCT01683058 ↗ |
| Known as | NSC-759266 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | OPC-14597 | “A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent...” NCT01122927 ↗7“A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of...” NCT00706654 ↗ “A Long-Term Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC 14597) as Maintenance...” NCT01149655 ↗ “A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients...” NCT01710709 ↗ “Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia” NCT01683058 ↗ “Intramuscular Formulation of Aripiprazole (OPC-14597)” NCT01567527 ↗ “OPC-14597 (Aripiprazole)” NCT00882362 ↗ “Aripiprazole, OPC-14597” NCT01909466 ↗ |
| Known as | OPC-14597 IMD | “Aripiprazole IM Depot Formulation (OPC-14597 IMD)” NCT02220712 ↗ |
| Known as | OPC-31 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | Opipza | ChEMBL registry synonym — accepted as the source's own label CHEMBL1112 ↗ |
| Known as | Rispridoen and Aripiprazole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00352339 ↗ |
| Action | Activate | “Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL1112 ↗2“Aripiprazole is a dopamine partial agonist” PMID 18765484 ↗ Sep 2008 “Dopamine D2 receptor partial agonist” CHEMBL1112 ↗ |
| Action | Inhibit | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL1112 ↗ |
| Modality | Other / unclassified | “Atypical antipsychotic” NCT01333072 ↗ |
| Route | Intramuscular | “Patients were randomly assigned to IM aripiprazole 1 mg, 5.25 mg, 9.75 mg, or 15 mg” PMID 17284138 ↗ Jan 2007 |
| Target | DRD2 | “Dopamine D2 receptor partial agonist” CHEMBL1112 ↗ |
| Target | HTR1A | “Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL1112 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL1112 ↗ |