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# Clarus Wants FDA Testosterone-Ester Guidance
- URL: https://www.fdaweb.com/clarus-wants-fda-testosterone-ester-guidance/
- Published: 2019-10-09T12:00:00.000Z
- Updated: 2026-09-15T01:55:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145211

Clarus says FDA should establish clear written guidance on safety and efficacy standards required for oral testosterone-ester prodrugs as testosterone replacement therapy for adult men with a deficiency or absence of endogenous testosterone. A company [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-4644-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) also asks that the agency not approve any pending NDA for an oral testosterone-ester to treat male hypogonadism that fails to meet the approval standards listed in the petition.

The company says FDA should address the specific criteria that oral testosterone-ester prodrugs must meet regarding primary efficacy, secondary efficacy, dose titration, concordance, food effect, and characterization of post-collection conversion of specific testosterone-ester to testosterone in blood of men treated with oral testosterone-ester to assess clinical testosterone response.

FDA approved 3/27 Clarus’ Jatenzo, the first U.S. oral testosterone-ester product indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.