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di indolylmethane (DIM)

New York Presbyterian Hospital · Phase 3 active Small molecule

di indolylmethane (DIM) is a Indole Small molecule drug developed by New York Presbyterian Hospital. It is currently in Phase 3 development for Prostate cancer prevention.

DIM is a natural compound that acts as an estrogen receptor antagonist and a weak estrogen receptor agonist.

DIM is a natural compound that acts as an estrogen receptor antagonist and a weak estrogen receptor agonist. Used for Prostate cancer prevention.

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 namedi indolylmethane (DIM)
SponsorNew York Presbyterian Hospital
Drug classIndole
TargetEstrogen receptor
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

DIM has been shown to have anti-cancer properties by inhibiting the growth of cancer cells and inducing apoptosis. It also has anti-inflammatory and antioxidant effects.

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 di indolylmethane (DIM)

What is di indolylmethane (DIM)?

di indolylmethane (DIM) is a Indole drug developed by New York Presbyterian Hospital, indicated for Prostate cancer prevention.

How does di indolylmethane (DIM) work?

DIM is a natural compound that acts as an estrogen receptor antagonist and a weak estrogen receptor agonist.

What is di indolylmethane (DIM) used for?

di indolylmethane (DIM) is indicated for Prostate cancer prevention.

Who makes di indolylmethane (DIM)?

di indolylmethane (DIM) is developed by New York Presbyterian Hospital (see full New York Presbyterian Hospital pipeline at /company/new-york-presbyterian-hospital).

What drug class is di indolylmethane (DIM) in?

di indolylmethane (DIM) belongs to the Indole class. See all Indole drugs at /class/indole.

What development phase is di indolylmethane (DIM) in?

di indolylmethane (DIM) is in Phase 3.

What are the side effects of di indolylmethane (DIM)?

Common side effects of di indolylmethane (DIM) include Nausea, Diarrhea.

What does di indolylmethane (DIM) target?

di indolylmethane (DIM) targets Estrogen receptor and is a Indole.

Related

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