> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on Acromegaly Drug Development
- URL: https://www.fdaweb.com/guide-on-acromegaly-drug-development/
- Published: 2023-01-30T12:00:00.000Z
- Updated: 2026-09-14T18:13:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153652

FDA is making available a [draft guidance](https://www.fda.gov/media/164858/download?ref=fdaweb.com) entitled “Acromegaly: Developing Drugs for Treatment.” The document provides recommendations about the clinical development of such drugs, and the agency says it is intended to serve as the basis for continued discussions with its Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public.

Under Phase 3 trial design considerations, the guidance says placebo-controlled trials have been conducted to previously support acromegaly drugs. “From an ethical perspective, this design is acceptable because treatment guidelines include the recommendation of periodic withdrawal of previous therapies, including subjects who require the lowest doses,” it says. “In addition, monitoring and timely control of acromegaly-related comorbidities during the trial (e.g., with antidiabetic, antihypertensive medications) and other protocol safeguards (e.g., inclusion/exclusion criteria, rescue criteria) can ensure the safety of subjects while receiving placebo.”

Additionally, FDA says that if an active-controlled trial is designed and uses a non-U.S.-approved comparator, data are needed to justify the “scientific relevance of the comparative data. In such cases, sponsors should consult the review division regarding their approach.” It also notes that if the test drug and comparator have different routes of administration or different148 regimens, the sponsor should consider a double-dummy trial design. FDA points out that blinding may be a difficult in such instances and sponsors should consider using placebo if a double-dummy trial design is not feasible.