Pharmaceutical Business Products
Otsuka prescription drugs on the global market
Central Nervous System
*brand name in EU
REXULTI / RXULTI*
REXULTI / RXULTI was discovered by Otsuka and is being co-developed and co-marketed, where approved, by Otsuka and Lundbeck for the treatment of schizophrenia. In the U.S. it is also co-marketed as an adjunctive treatment for major depressive disorder. In 2018 it was launched in Japan, and is now sold in approximately 60 countries worldwide. It acts as an SDAM(serotonin-dopamine activity modulator).
- *The information in the product description is current as of August 2022.
ABILIFY Maintena, a prolonged release aquaeous suspension for intramuscular injection
ABILIFY Maintena is administered by injection once monthly. It is a long-acting formulation of the antipsychotic ABILIFY (aripiprazole). In 2013, ABILIFY Maintena was launched in the U.S. with an indication for schizophrenia and subsequently has become available in over 50 countries. In 2017 the product was approved for use in treatment of bipolar I disorder in the U.S. and Canada. In Japan, it was launched in 2015 for the treatment of schizophrenia and approved for the additional indication of bipolar I disorder in 2020.
- *The information in the product description is current as of August 2022.
ABILIFY
ABILIFY is an antipsychotic with the world's first dopamine D2 receptor partial agonist action, which was discovered by Otsuka. In Japan it was launched in 2006 for the treatment of schizophrenia and in 2012 obtained an additional indication for improvement of manic symptoms of bipolar disorder.
- *The information in the product description is current as of August 2022.
Restless legs syndrome agent
Neupro Patches
Neupro is the world's only once-daily transdermal dopamine agonist. In 2002 Otsuka obtained development and marketing rights in Japan from the Belgian company UCB. In Japan, it has been marketed since 2013.
- *The information in the product description is current as of August 2022.
Selincro
Selincro, the first dual-acting opioid system modulator in Japan, acts on the brain's motivational system, which is dysregulated in patients with alcohol dependence. In 2013 Otsuka formed an agreement with Lundbeck on the development and commercialization in Japan of Lundbeck's Selinclo. It was launched in 2019 by Otsuka.
- *The information in the product description is current as of August 2022.
AJOVY
AJOVY, owned by Teva Pharmaceutical Industries, Ltd., is a subcutaneous injection of an anti-CGRP (calcitonin gene-related peptide) monoclonal antibody, which is produced by recombinant DNA technology. CGRP is thought to play an important role in migraine attacks. AJOVY targets the CGRP ligand, inhibiting its binding to the CGRP receptor. In 2017 Otsuka obtained development and marketing rights in Japan, and it has been marketed since 2021.
- *The information in the product description is current as of August 2022.
Oncology
(tyrosine kinase inhibitor)
(tyrosine kinase inhibitor)
ICLUSIG
ICLUSIG, discovered by Ariad (acquired by Takeda in 2017), an oral tyrosine kinase inhibitor, targets BCR-ABL, an abnormal kinase expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ICLUSIG was launched in Japan in 2016.
- *The information in the product description is current as of August 2022.
Busulfex
Busulfex is a conditioning agent prior to bone marrow transplantation in blood cancer. It has been accepted globally as a standard treatment to support medical transplantation.
- *The information in the product description is current as of August 2022.
Cardiovascular and Renal areas
*brand name outside Japan for ADPKD indication (**brand name in U.S.)
Samsca / JINARC* / JYNARQUE**
Samsca is an Otsuka-discovered aquaretic with a novel mechanism of action that promotes excretion from the body of water only without affecting the excretion of electrolytes. It does this by inhibiting the antidiuretic hormone vasopressin. In Japan, it was approved for edema from heart failure (accumulation of fluid) in 2010 and edema for cirrhotic patients in 2013. In 2014 Samsca was approved in Japan as the first-in-the-world treatment of autosomal dominant polycystic kidney disease (ADPKD), and additional approvals have been received in geographies including North America and the EU member states. Currently, Samsca / JINARC / JYNARQUE is approved for several indications in over 40 countries.
- *The information in the product description is current as of August 2022.
SAMTASU
SAMTASU is a prodrug of oral tolvaptan (generic name is tolvaptan sodium phosphate). A prodrug is a medication that is converted into an active drug in the human body following administration. Tolvaptan, discovered by Otsuka, is a novel compound that is as an antagonist of the vasopressin V2-receptor. In Japan, SAMTASU was approved for edema from heart failure (accumulation of fluid) in 2022.
- *The information in the product description is current as of August 2022.
Pletaal
Pletaal, discovered by Otsuka, inhibits platelet aggregation and has peripheral vasodilator effects. In Japan it was launched in 1988 for the treatment of symptoms associated with chronic arterial obstruction and was also approved in 2003 for prevention of recurrent cerebral infarction. In 2010, Pletaal OD tablets were released in Japan.
- *The information in the product description is current as of August 2022.
Gastrointestinal
Mucosta
Otsuka-discovered Mucosta has an action that protects the gastric mucosa in addition to suppressing free radicals and inflammation in the stomach. It was launched in Japan in 1990 and is now sold in multiple countries. It is widely used as a drug to control gastric mucosa injury triggered by various causes such as use of painkillers and the effects of Helicobacter pylori.
- *The information in the product description is current as of August 2022.
Infectious diseases
DELTYBA
DELTYBA, discovered by Otsuka, is one of the first new anti-tuberculosis (TB) agents in nearly 40 years. It has a new mechanism of action with antimicrobial effect by inhibition of the production of mycolic acids, which form the cell wall of TB bacteria. As a treatment for multidrug-resistant TB, DELTYBA was approved in Europe in 2014. In Japan, it was also launched in 2014. In 2015 it was listed in the WHO Essential Medicines List. Currently, DELTYBA is available in over 120 countries.
- *The information in the product description is current as of August 2022.
Ophthalmology
Mucosta ophthalmic suspension
Mucosta ophthalmic suspension is a novel dry eye treatment with action that repairs corneal and conjunctival damage by promoting the production of mucin. It was launched in Japan in 2012 as a disposable, unit-dose formulation.
- *The information in the product description is current as of August 2022.
Mikeluna combination ophthalmic solution
Mikeluna combination ophthalmic solution is an once-daily eye drop containing a combination of the Otsuka-developed β-blocker cartelol hydrochloride (Mikelan LA) and the prostaglandin analogue latanoprost. It launched in Japan in 2017.
- *The information in the product description is current as of August 2022.
Dermatology
Moizerto
Moizerto, discovered by Otsuka, is a non-steroidal, topical phosphodiesterase type-4 inhibitor (commonly called a PDE4 inhibitor). PDE4 inhibitors improve the symptoms of atopic dermatitis such as red and itchy skin, through suppression of the production of chemical mediators such as pro-inflammatory cytokines and through other anti-inflammatory effects. It was launched in 2022 as the first topical PDE4 inhibitor approved in Japan for the treatment of atopic dermatitis.
- *The information in the product description is current as of August 2022.
Diagnostics
UBIT tablet
UBIT, discovered by Otsuka, is a diagnostic agent that measures 13C-Urea in the breath to detect the presence of Helicobacter pylori in the stomach.
- *The information in the product description is current as of August 2022.
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