Last reviewed 2026-05-23 · How we verify

Moramide (DEXTROMORAMIDE)

Phase 2 active Small molecule Under review Quality 0/100

Moramide (generic name: DEXTROMORAMIDE) is a dextromoramide drug. It is currently in Phase 2 development for Severe pain.

Dextromoramide works by binding to opioid receptors in the brain, spinal cord, and other areas to produce analgesia and euphoria.

Moramide is a small molecule that acts as an agonist to the opioid receptors, specifically targeting the mu, kappa, and delta subtypes. It is classified as an agonist within the opioid receptor modality.

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 name	DEXTROMORAMIDE
Drug class	dextromoramide
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your body has special locks called opioid receptors. Dextromoramide is a key that fits into these locks, which helps to block pain signals to the brain and release feel-good chemicals called endorphins. This can provide relief from severe pain, but it can also lead to dependence and other side effects.

Approved indications

Severe pain

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:

Moramide CI brief — competitive landscape report
Moramide updates RSS · CI watch RSS

Frequently asked questions about Moramide

What is Moramide?

Moramide (DEXTROMORAMIDE) is a dextromoramide drug, indicated for Severe pain.

How does Moramide work?

Dextromoramide works by binding to opioid receptors in the brain, spinal cord, and other areas to produce analgesia and euphoria.

What is Moramide used for?

Moramide is indicated for Severe pain.

What is the generic name of Moramide?

DEXTROMORAMIDE is the generic (nonproprietary) name of Moramide.

What drug class is Moramide in?

Moramide belongs to the dextromoramide class. See all dextromoramide drugs at /class/dextromoramide.

What development phase is Moramide in?

Moramide is in Phase 2.

Drug class: All dextromoramide drugs
Therapeutic area: All drugs in Pain
Indication: Drugs for Severe pain

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