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What changed—and what did not
A withdrawn request, a staff recommendation and a panel vote are different steps. Keep them separate.
Semax status: September 30, 2026. Rulemaking facts: September 26, 2026.
The request was withdrawn
The Food and Drug Administration, or FDA, page marked current on April 22, 2026 places Semax among ingredient requests that were withdrawn.
That page still displays the agency’s safety concerns beside Semax.
The record checked September 30, 2026 gives no date for when the request was withdrawn.
Withdrawn means the group that asked for Semax to go on the ingredient list took back its request.
The FDA proposed leaving it out
For the July 2026 meeting, FDA staff recommended leaving both Semax ingredient forms off the pharmacy list: Semax itself, called the free base, and Semax acetate.
These are names for two chemical forms of the ingredient, rather than names for nose drops or injections. Ask which form a proposed product contains.
This was a staff proposal, rather than a final agency decision.
The FDA’s advisory panel gives it advice on these questions.
The official outcome is still missing
The panel discussed Semax on July 24, 2026.
The FDA meeting page had no written meeting summary, no word-for-word account and no official vote record when checked September 30, 2026.
Under the rules checked September 26, 2026, even a panel vote in favour would be advice, not a change in the law.
To change the ingredient list, the FDA must follow a process for changing its rules that lets the public comment.
Brief source notes
At the end of this chapter
Keep this in mind.
As of September 2026, withdrawal of the Semax request is not approval to compound it.