A detailed critique published on The Vajenda says Midi Health's newly launched compounded sermorelin is being sold to midlife women on evidence that does not exist in published, peer-reviewed form. The piece works through every citation Midi posts in support of the product and reports that the trail repeatedly ends in review articles, book chapters and conference abstracts rather than trials.

Sermorelin is a synthetic fragment of growth hormone-releasing hormone, specifically its first 29 amino acids, which is why it is often written as GHRH 1-29. It stimulates the pituitary to release growth hormone, which in turn raises IGF-1. The critique notes that Midi's own marketing describes it as "non hormonal," and invites readers to decide whether a chemically modified fragment of a hormone qualifies.

What the approval actually covers

Sermorelin was FDA-approved in 1997 under the name Geref, for children with growth hormone deficiency and for diagnostic testing of pituitary function. The manufacturer pulled it from the market in 2008 for commercial reasons, and the review argues that safety data attached to an approved product for approved indications cannot be transferred to a compounded version sold for energy, recovery or metabolism.

One published trial in adults

The only published peer-reviewed study in adult women the author could locate is a 2006 randomized, double-blind, placebo-controlled trial of 89 women and men aged 60 to 85, using 1 mg nightly for five to six months. It reported some improvement in cognition, though the authors themselves wrote that whether the changes prove clinically meaningful depends on future research. A 1997 study of a closely related but different peptide found improvements in lean mass, insulin sensitivity, well-being and libido in the nine men but not in the ten women.

The dosing question nobody answers

Midi lists a starting dose of 0.2 mg by injection, one-fifth of the dose used in that single published trial, and the critique reports finding no dose-finding studies to explain it. The company also recommends IGF-1 testing every three to six months, on top of a $179 per month price, despite no validated IGF-1 target for sermorelin treatment in women.

Bottom line

The Endocrine Society's 2023 scientific statement is quoted flatly: no therapy to increase GH secretion or action is approved as an anti-aging intervention. The author's closing position is that the burden of evidence sits with the company selling the product, and that a placebo-controlled trial in perimenopausal or postmenopausal women would settle the argument.