A systematic review/meta-analysis and a comparative treatment study indicate D-chiro-inositol provides benefits for some metabolic measures, ovulation, menstrual regularity, and insulin resistance in PCOS patients.
Studied as a therapy for pcos in 4 interventional trials · highest reached Phase 3 · completed.
Source: ClinicalTrials.gov (U.S. National Library of Medicine).
No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.
Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.
This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.
Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).