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Methyldihydromorphinone (METOPON)

Phase 2 active Small molecule ✓ Verified May 2026

Methyldihydromorphinone (generic name: METOPON) is a drug. It is currently in Phase 2 development.

METOPON is a synthetic opioid that binds to opioid receptors in the brain to produce analgesic effects.

Methyldihydromorphinone, also known as Metopon, is a small molecule. It is a synthetic opioid with various synonyms, including 5-METHYLDIHYDROMORPHINONE, IDS-NM-006, and METHYLDIHYDROMORPHINONE.

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 nameMETOPON
ModalitySmall molecule
Therapeutic areaPain
PhasePhase 2

Mechanism of action

Imagine your brain has special locks called opioid receptors. METOPON is a key that fits into these locks, which helps to block pain signals. This can provide relief from pain, but it can also have side effects and risks, especially when used improperly.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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 Methyldihydromorphinone

What is Methyldihydromorphinone?

Methyldihydromorphinone (METOPON) is a Small molecule drug.

How does Methyldihydromorphinone work?

METOPON is a synthetic opioid that binds to opioid receptors in the brain to produce analgesic effects.

What is the generic name of Methyldihydromorphinone?

METOPON is the generic (nonproprietary) name of Methyldihydromorphinone.

What development phase is Methyldihydromorphinone in?

Methyldihydromorphinone is in Phase 2.

Related

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