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D-chiro-inositol

Biosearch S.A. · Phase 2 active Small molecule

D-chiro-inositol is a Insulin sensitizer Small molecule drug developed by Biosearch S.A.. It is currently in Phase 2 development for Polycystic ovary syndrome (PCOS). Also known as: Cis-1,2,4-trans-3,5,6-cyclohexanehexol.

D-chiro-inositol is involved in insulin signaling and glucose metabolism.

D-chiro-inositol is involved in insulin signaling and glucose metabolism. Used for Polycystic ovary syndrome (PCOS).

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034 —
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameD-chiro-inositol
Also known asCis-1,2,4-trans-3,5,6-cyclohexanehexol
SponsorBiosearch S.A.
Drug classInsulin sensitizer
ModalitySmall molecule
Therapeutic areaMetabolic disorders
PhasePhase 2

Mechanism of action

It acts as a second messenger in insulin signaling pathways, influencing glucose uptake and metabolism in cells. D-chiro-inositol has been shown to improve insulin sensitivity and glucose metabolism in various studies.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about D-chiro-inositol

What is D-chiro-inositol?

D-chiro-inositol is a Insulin sensitizer drug developed by Biosearch S.A., indicated for Polycystic ovary syndrome (PCOS).

How does D-chiro-inositol work?

D-chiro-inositol is involved in insulin signaling and glucose metabolism.

What is D-chiro-inositol used for?

D-chiro-inositol is indicated for Polycystic ovary syndrome (PCOS).

Who makes D-chiro-inositol?

D-chiro-inositol is developed by Biosearch S.A. (see full Biosearch S.A. pipeline at /company/biosearch-s-a).

Is D-chiro-inositol also known as anything else?

D-chiro-inositol is also known as Cis-1,2,4-trans-3,5,6-cyclohexanehexol.

What drug class is D-chiro-inositol in?

D-chiro-inositol belongs to the Insulin sensitizer class. See all Insulin sensitizer drugs at /class/insulin-sensitizer.

What development phase is D-chiro-inositol in?

D-chiro-inositol is in Phase 2.

What are the side effects of D-chiro-inositol?

Common side effects of D-chiro-inositol include Nausea, Headache, Diarrhea.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing