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Sunovion
and
Otsuka
Initiate Clinical Development of
Ulotaront
for the Treatment of
Generalized Anxiety Disorder
2023-04-26
·
BioSpace
临床3期
突破性疗法
–Approximately 7.5 Million People in The U.S. Are Living with
Generalized Anxiety Disorder (GAD)
1,2– MARLBOROUGH, Mass. & PRINCETON, N.J.--(BUSINESS WIRE)--
Sunovion Pharmaceuticals Inc.
(
Sunovion
) and
Otsuka Pharmaceutical Development & Commercialization, Inc.
(
Otsuka
) today announced that the first patient has been randomized in a Phase 2/3 clinical study evaluating
ulotaront
, a
trace amine-associated receptor 1 (TAAR1)
agonist with
5-HT1A
agonist activity, for the treatment of
generalized anxiety disorder (GAD)
. In addition to GAD,
ulotaront
is being investigated in late-stage clinical studies for the treatment of
schizophrenia
and for the adjunctive treatment of
major depressive disorder (MDD)
. This press release features multimedia. View the full release here: “
Generalized anxiety disorder
is a chronic condition characterized by excessive
anxiety
or worries,
sleep disturbances
, changes in appetite and impairment of social and occupational activities which can have a profound impact on nearly all aspects of an individual’s life,” said Armin Szegedi, M.D., Ph.D., Senior Vice President, Chief Medical Officer at
Sunovion
. “Preliminary data from preclinical and clinical studies of
ulotaront
suggest an anxiety-reducing effect, which we aim to understand further in patients with GAD. We believe that
ulotaront
is a potentially important novel mechanism and therapeutic advance for the treatment of GAD and other serious mental health conditions.” The multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study will evaluate
ulotaront
’s efficacy and safety in people living with GAD. A total of 434 patients are expected to be randomized into two treatment groups, receiving either
ulotaront
(
SEP-363856
, 50–75 mg/day) or placebo in a 1:1 ratio for eight weeks. The primary endpoint is reduced
anxiety
symptoms, as measured by a change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score, compared to placebo at Week 8. “With the expansion of
ulotaront
’s clinical development program to a third indication, we are making significant progress towards goals we set for co-development and co-commercialization with
Sunovion
Sunovion
to address areas of high unmet need for people living with serious
mental illnesses
,” said John Kraus, M.D., Ph.D., Executive Vice President and Chief Medical Officer at
Otsuka
. “We believe that
ulotaront
has the potential to help those living with GAD safely and effectively manage their symptoms and we look forward to advancing the understanding of this innovative compound.” About Ulotaront (SEP-363856)
Ulotaront
, a
TAAR1
agonist with
5-HT1A
agonist activity, is currently under investigation for the treatment of
schizophrenia
,
generalized anxiety disorder (GAD)
and the adjunctive treatment of
major depressive disorder (MDD)
with additional indications under consideration.
Ulotaront
was granted Breakthrough Therapy Designation by the
U.S. Food and Drug Administration (FDA)
for the treatment of
schizophrenia
in 2019.
Ulotaront
is the first
TAAR1
agonist to enter Phase 3 clinical studies in adults and adolescents (13 to 17 years) with
schizophrenia
.
Ulotaront
is also the first
TAAR1
agonist to enter Phase 2/3 clinical studies in GAD and the adjunctive treatment of
MDD
.
Ulotaront
is being jointly developed and commercialized as part of a collaboration between
Otsuka Pharmaceutical Co., Ltd
,
Sunovion
, and its parent company
Sumitomo Pharma Co., Ltd.
Sunovion
discovered
ulotaront
in collaboration with
PsychoGenics
based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube® platform and associated artificial intelligence algorithms. About Generalized
Anxiety Disorder
An estimated 374 million people globally are impacted by
anxiety disorders.3
Generalized anxiety disorder (GAD)
is a type of
anxiety disorder
characterized by excessive anxiety and worry about a variety of events or activities (e.g., work or school performance) that occurs more days than not, for at least six months.4 People with GAD find it difficult to control their worry, feel restless or on edge, fatigued, have difficulty concentrating, feel irritable or have trouble falling or staying asleep.5 GAD may cause impairment in social and occupational functioning, or other areas of daily life and may be brought on or exacerbated by stressful life events.5 Roughly 20 million people in the U.S. will experience GAD at some point in their lifetime.6,7 About
Sunovion Pharmaceuticals Inc.
(
Sunovion
)
Sunovion
is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions.
Sunovion
has charted new paths to life-transforming treatments that reflect an ongoing commitment to research and development for people living with serious psychiatric and neurological conditions. Headquartered in Marlborough, Mass.,
Sunovion
is an indirect, wholly-owned subsidiary of
Sumitomo Pharma Co., Ltd.
Sunovion Pharmaceuticals Canada Inc.
, based in Mississauga, Ontario, is a wholly-owned direct subsidiary of
Sunovion Pharmaceuticals Inc.
Additional information can be found on the company’s websites: and . Connect with
Sunovion
on Twitter, LinkedIn, Facebook, and YouTube. As announced on April 3,
Sunovion
will combine with affiliate companies
Sumitomo Pharma America Holdings, Inc.
,
Sumitovant Biopharma, Inc.
,
Myovant Sciences, Inc.
,
Urovant Sciences, Inc.
,
Enzyvant Therapeutics, Inc.
, and Sumitomo Pharma Oncology, Inc. to form Sumitomo Pharma America, Inc. effective July 1, 2023. About
Sumitomo Pharma Co., Ltd.
Sumitomo Pharma
is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries.
Sumitomo Pharma
aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the
Oncology
area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Today,
Sumitomo Pharma
has about 7,000 employees worldwide. Additional information about
Sumitomo Pharma
is available through its corporate website at . About
Otsuka Pharmaceutical Co., Ltd.
(
Otsuka
)
Otsuka
is a global healthcare company with the corporate philosophy: “
Otsuka
–people creating new products for better health worldwide.”
Otsuka
researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals,
Otsuka
is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in
oncology
and on several under-addressed diseases including
tuberculosis
, a significant global public health issue. These commitments illustrate how
Otsuka
is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka
established a presence in the U.S. in 1973 and today its U.S. affiliates include
Otsuka Pharmaceutical Development & Commercialization, Inc.
(
OPDC
) and
Otsuka America Pharmaceutical, Inc.
(
OAPI
). These two companies’ 1,700 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology, and cardiology, using cutting-edge technology to address unmet healthcare needs.
OPDC
and
OAPI
are indirect subsidiaries of
Otsuka Pharmaceutical Company, Ltd.
, which is a subsidiary of
Otsuka Holdings Co., Ltd.
headquartered in Tokyo, Japan. The
Otsuka group
of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.1 billion in 2022. All
Otsuka
stories start by taking the road less traveled. Learn more about
Otsuka
in the U.S. at and connect with us on LinkedIn and Twitter at @OtsukaUS.
Otsuka Pharmaceutical Co., Ltd.
’s global website is accessible at . SUNOVION is a registered trademark of
Sumitomo Pharma Co., Ltd.
Sunovion Pharmaceuticals Inc.
is a U.S. subsidiary of
Sumitomo Pharma Co., Ltd.
© 2023
Sunovion Pharmaceuticals Inc.
All rights reserved. For a copy of this release, visit
Sunovion
’s website at and
Otsuka
’s website at . References Kessler, RC., et al. Twelve‐month and lifetime prevalence and lifetime morbid risk of
anxiety and mood disorders
in the United States. Int J Methods Psychiatr Res. 2012 Sep; 21(3): 169–184. Published online 2012 Aug 1. doi: 10.1002/mpr.1359 US Census Bureau. U.S. Adult Population Grew Faster Than Nation’s Total Population From 2010 to 2020. 2021.
COVID-19
Mental Disorders
Collaborators. Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the
COVID-19 pandemic
. Lancet 2021; 398: 1700–12 (21)02143-7 National Institute of Mental Health. General Anxiety Disorder. National Institute of Mental Health. When Worry Gets Out of Control. Szuhany KL, Simon NM.
Anxiety disorders
: a review. JAMA. 2022;328(24):2431-2445. doi:10.1001/jama.2022.22744 US Census Bureau. U.S. and World Population Clock. 2023.
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机构
Sumitomo Pharma America, Inc.
Otsuka Co., Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
[+12]
适应症
广泛性焦虑障碍
精神分裂症
中度重度抑郁症
[+9]
靶点
TAAR1
5-HT1A receptor
药物
Ulotaront
Monoamine oxidase inhibitors(Sunovion)
标准版
¥
16800
元/账号/年
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