21 CFR § 520.2598 - Trilostane.

---
identifier: "/us/cfr/t21/s520.2598"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.2598 - Trilostane."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.2598"
section_name: "Trilostane."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.2598 Trilostane.

(a) *Specifications.* Each capsule contains 5, 10, 20, 30, 60, or 120 milligrams (mg) trilostane.

(b) *Sponsor.* See No. 043264 in § 510.600 of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* The starting dose is 1.0 to 3.0 milligrams per pound (2.2 to 6.7 milligrams per kilogram) once a day.

(2) *Indications for use.* For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[74 FR 21767, May 11, 2009, as amended at 74 FR 30464, June 26, 2009; 80 FR 53460, Sept. 4, 2015; 87 FR 58962, Sept. 29, 2022; 89 FR 85426, Oct. 28, 2024]