Notice2026-07615
Potential New Indication for Testosterone Replacement Therapy
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 20, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have reviewed information in published literature that seems promising regarding the potential use of testosterone replacement therapy (TRT) in the treatment of low libido in men with decreased libido associated with idiopathic hypogonadism. We encourage holders of approved TRT new drug applications (NDAs) that are interested in seeking approval for this new indication to contact FDA for further information regarding submission of a supplemental NDA, including data needed to support an approval.
Full Text
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<title>Federal Register, Volume 91 Issue 75 (Monday, April 20, 2026)</title>
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[Federal Register Volume 91, Number 75 (Monday, April 20, 2026)]
[Notices]
[Pages 21002-21003]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07615]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6743]
Potential New Indication for Testosterone Replacement Therapy
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing that we have reviewed information in published literature
that seems promising regarding the potential use of testosterone
replacement therapy (TRT) in the treatment of low libido in men with
decreased libido associated with idiopathic hypogonadism. We encourage
holders of approved TRT new drug applications (NDAs) that are
interested in seeking approval for this new indication to contact FDA
for further information regarding submission of a supplemental NDA,
including data needed to support an approval.
DATES: Holders of currently approved TRT NDAs interested in seeking
approval for the treatment of low libido in men with decreased libido
associated with idiopathic hypogonadism are encouraged to contact FDA
(see FOR FURTHER INFORMATION CONTACT) by April 30, 2026, for further
information regarding submission of a supplemental NDA, including data
needed to support the new indication.
FOR FURTHER INFORMATION CONTACT: Dorsa Jalali, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5333, 240-402-0543,
<a href="/cdn-cgi/l/email-protection#a3c7ccd1d0c28dc9c2cfc2cfcae3c5c7c28dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="1e7a716c6d7f30747f727f72775e787a7f3076766d30797168">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Testosterone is the principal hormone secreted by the testes and is
the main androgenic steroid in males. Endogenous androgens like
testosterone are necessary and responsible for the normal growth and
development of the male sex organs and for the development and
maintenance of secondary sex characteristics. Approved TRT drug
products have been used for decades in the United States for certain
conditions associated with a deficiency or absence of endogenous
testosterone. In general, the goal of TRT is to reliably and safely
restore concentrations of testosterone and its major metabolites (e.g.,
dihydrotestosterone, estradiol) to normal levels in men with low or
absent testosterone levels from structural or genetic causes. FDA-
approved TRTs include drug products that vary by dosage forms,
strengths, and dosing regimens. These TRTs are currently indicated for
testosterone replacement therapy in adult males for conditions
associated with a deficiency or absence of endogenous testosterone,
specifically primary hypogonadism (congenital or acquired) and
hypogonadotropic hypogonadism (congenital or acquired). The approved
TRTs also bear a limitation of use in the labeling to note that safety
and efficacy of TRT in men with ``age-related hypogonadism'' have not
been established.\1\
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\1\ See, e.g., FDA-approved labeling for ANDROGEL (NDA 021015),
ANDRODERM (NDA 020489), AVEED (NDA 022219), and JATENZO (NDA 206089)
available at <a href="https://www.accessdata.fda.gov/scripts/CDER/daf/">https://www.accessdata.fda.gov/scripts/CDER/daf/</a>.
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II. Potential New Indication for TRT
On December 10, 2025, FDA convened an expert panel, ``Expert Panel
on Testosterone Replacement Therapy for Men'' (recording available at
<a href="https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-testosterone-replacement-therapy-men-12102025">https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-testosterone-replacement-therapy-men-12102025</a>), to discuss TRT,
including the use of testosterone in men for signs and symptoms
associated with idiopathic hypogonadism (i.e., low testosterone levels
from inadequate testicular stimulation or function without a known
underlying cause).\2\ The expert panel members discussed their
individual views and available information on a range of topics related
to the risks and benefits of testosterone therapy, including a
potential broadening of the current approved indication for
testosterone products to include treatment of men with symptomatic
hypogonadism without known structural or genetic etiologies.
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\2\ In conjunction with the meeting of the expert panel, FDA
announced a request for information regarding the scientific,
regulatory, and practical considerations that shape TRT use (see 90
FR 57474, Dec. 11, 2025). FDA is in the process of reviewing the
comments received.
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FDA has conducted a preliminary review of the published literature
on possible use of TRT to treat men with symptomatic idiopathic
hypogonadism. In evaluating symptomatic idiopathic hypogonadism, FDA
reviewed articles meeting the following criteria: (1) the studies
involved prospective, controlled trials; and (2) the articles contained
information about the study protocol, endpoints, statistical methods,
sample size, and blinding procedures. Our preliminary review of the
literature suggests that TRT may be safe and effective in treating low
libido in men with decreased libido associated with idiopathic
hypogonadism. The published literature we reviewed regarding this
potential indication for TRT is listed in the REFERENCES section.
We encourage holders of currently approved TRT NDAs interested in
seeking approval for the treatment of low libido in men with decreased
libido associated with idiopathic hypogonadism to contact FDA (see FOR
FURTHER INFORMATION CONTACT) by April 30, 2026, for further information
regarding submission of a supplemental NDA, including data needed to
support the new indication.\3\ Approval of any new indication will be
based on rigorous scientific evidence and comprehensive risk-benefit
analysis, consistent with applicable law.
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\3\ Drug products approved by FDA in supplemental NDAs
(including new indications) may be protected by patents issued by
the U.S. Patent and Trademark Office and/or by periods of
exclusivity. Patent protections and exclusivities may have
implications for the timing of approval of subsequent NDAs submitted
pursuant to section 505(b)(2) of Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355(b)(2)) and abbreviated new drug
applications (ANDAs), including supplemental 505(b)(2) NDAs and
ANDAs. See, e.g., sections 505(c)(3), 505(j)(5)(B), 505(j)(5)(F),
505A, and 527 of the FD&C Act (21 U.S.C. 355(c)(3), 355(j)(5)(B),
355(j)(5)(F), 355A, and 360cc); see also 21 CFR 314.107, 314.108,
316.31, and 316.34.
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III. References
The following references are on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
these are not available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
as these references are copyright protected. Some may be available at
the website addresses listed. Although FDA verified the website
addresses in this document, please note that websites are subject to
change over time.
1. Pencina KM, Travison TG, Cunningham GR, Lincoff AM, Nissen SE,
Khera M, et al., 2024, ``Effect of Testosterone Replacement Therapy
on Sexual Function and Hypogonadal Symptoms in Men with
Hypogonadism,'' J Clin Endocrinol Metab, 109(2):569-580. Available
at https://doi.org/10.1210/
[[Page 21003]]
clinem/dgad484.
2. Snyder PJ, Bhasin S, Cunningham GR, Matsumoto AM, Stephens-
Shields AJ, Cauley JA, et al., 2016, ``Effects of Testosterone
Treatment in Older Men,'' N Engl J Med, 374(7):611-624. Available at
<a href="https://doi.org/10.1056/nejmoa1506119">https://doi.org/10.1056/nejmoa1506119</a>.
(Authority: 21 U.S.C. 355.)
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07615 Filed 4-16-26; 11:15 am]
BILLING CODE 4164-01-P
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