Notice2025-09844
Prospective Grant of an Exclusive Patent License: Exceptionally Selective D2 Dopamine Receptor Antagonists as Therapeutics
Primary source
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Published
June 2, 2025
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Institute of Neurological Disorders and Stroke and the National Center for Advancing Translational Sciences, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Psycala Bio, Inc. (Psycala), incorporated in Delaware.
Full Text
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<title>Federal Register, Volume 90 Issue 104 (Monday, June 2, 2025)</title>
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[Federal Register Volume 90, Number 104 (Monday, June 2, 2025)]
[Notices]
[Pages 23341-23342]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09844]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Exceptionally
Selective D2 Dopamine Receptor Antagonists as Therapeutics
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Institute of Neurological Disorders and Stroke
and the National Center for Advancing Translational Sciences,
institutes of the National Institutes of Health, Department of Health
and Human Services, are contemplating the grant of an Exclusive Patent
License to practice the inventions embodied in the Patents and Patent
Applications listed in the Supplementary Information section of this
Notice to Psycala Bio, Inc. (Psycala), incorporated in Delaware.
DATES: Only written comments and/or applications for a license which
are received by the National Institute of Neurological Disorders and
Stroke Technology Transfer on or before July 17, 2025 will be
considered.
[[Page 23342]]
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Susan Ano, Ph.D., Chief, Technology Transfer
Branch, Telephone: 301-435-5515; Email: <a href="/cdn-cgi/l/email-protection#285b5d5b49460649464768464140064f475e"><span class="__cf_email__" data-cfemail="92e1e7e1f3fcbcf3fcfdd2fcfbfabcf5fde4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
``2,4-Diphenyl-3,4-Dihydroquinazoline Derivatives and Related
Compounds as D2 Dopamine Receptor-Selective Antagonists''.
U.S. Patent Application No. 63/666,563, filed July 1, 2024 (HHS
Reference E-119-2021-0-US-01).
The patent rights in this invention have been assigned to the
government of the United States of America.
The prospective exclusive license territory may be worldwide, and
the field of use may be limited to the following:
NCGC-1360 ((s)-4-(6-chloro-2-(5-methoxypyridin-2-yl)-4-
phenylquinazolin-3(4h)-yl)-2-methylbutan-2-ol) and related analogs
for the treatment of central nervous system disorders, including but
not limited to schizophrenia spectrum and other psychotic disorders,
bipolar disorder and related disorders, and depressive disorders as
classified by the Diagnostic and Statistical Manual of Mental
Disorders (DSM V).
Researchers at NINDS and NCATS have developed a new class of
therapeutic agents that may significantly advance the treatment of CNS
disorders. These compounds are antagonists with high selectivity for
the dopamine D2 receptor (D2R), showing over 1,000-fold selectivity
compared to D3R and D4R. Promising in vitro ADME (Absorption,
Distribution, Metabolism, and Excretion) data and in vivo
pharmacokinetics indicate effective brain penetration, positioning
these molecules as potential treatments for schizophrenia, bipolar
disorder, and depression. Designed to minimize off-target side effects,
particularly extrapyramidal motor side effects (EPS), these compounds
maintain therapeutic efficacy. These compounds exhibit atypical
antipsychotic properties without typical off-target effects and are
expected to have reduced overall side effects. These molecules can be
administered in various pharmaceutical forms, either alone or in
combination with other therapeutic agents.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing,
and the prospective exclusive license may be granted unless within
forty-five (45) days from the date of this published Notice, the
National Institute of Neurological Disorders and Stroke receives
written evidence and argument that establishes that the grant of the
license would not be consistent with the requirements of 35 U.S.C. 209
and 37 CFR part 404.
In response to this Notice, the public may file comments or
objections. Comments and objections, other than those in the form of a
license application, will not be treated confidentially and may be made
publicly available.
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information from these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Susan E. Ano,
Chief, Technology Transfer Branch, National Institute of Neurological
Disorders and Stroke.
[FR Doc. 2025-09844 Filed 5-30-25; 8:45 am]
BILLING CODE 4140-01-P
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