Last reviewed 2026-05-22 · How we verify

Morphine Dinicotinate (NICOMORPHINE)

Phase 2 active Small molecule ✓ Verified May 2026 Quality 24/100

Morphine Dinicotinate (generic name: NICOMORPHINE) is a Opioid Agonist drug. It is currently in Phase 2 development.

NICOMORPHINE works by binding to opioid receptors in the brain, producing feelings of pain relief and potentially other effects.

Morphine dinicotinate is a small molecule. It is also known by various synonyms, including 3,6-DINICOTINOYLMORPHINE, DEA NO. 9312, IDS-NN-003, MORPHINE DINICOTINATE, MORPHINE DINICOTINATE (ESTER), and MORPHINE DINICOTINATE ESTER.

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	NICOMORPHINE
Drug class	Opioid Agonist
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your brain has special locks called opioid receptors. NICOMORPHINE is a key that fits into these locks, which helps to block pain signals and produce feelings of relaxation and pain relief. This is how it helps to manage pain, but it can also have other effects on the body.

Approved indications

No approved indications tracked.

Common side effects

Macular degeneration
Chronic sinusitis
Paraesthesia oral
Procedural pain

Competitive intelligence

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

Morphine Dinicotinate CI brief — competitive landscape report
Morphine Dinicotinate updates RSS · CI watch RSS

Frequently asked questions about Morphine Dinicotinate

What is Morphine Dinicotinate?

Morphine Dinicotinate (NICOMORPHINE) is a Opioid Agonist drug.

How does Morphine Dinicotinate work?

NICOMORPHINE works by binding to opioid receptors in the brain, producing feelings of pain relief and potentially other effects.

What is the generic name of Morphine Dinicotinate?

NICOMORPHINE is the generic (nonproprietary) name of Morphine Dinicotinate.

What drug class is Morphine Dinicotinate in?

Morphine Dinicotinate belongs to the Opioid Agonist class. See all Opioid Agonist drugs at /class/opioid-agonist.

What development phase is Morphine Dinicotinate in?

Morphine Dinicotinate is in Phase 2.

What are the side effects of Morphine Dinicotinate?

Common side effects of Morphine Dinicotinate include Macular degeneration, Chronic sinusitis, Paraesthesia oral, Procedural pain.

Drug class: All Opioid Agonist drugs
Therapeutic area: All drugs in Pain

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