Last reviewed 2026-05-29 · How we verify

Heptazone (PHENADOXONE)

Phase 2 active Small molecule ✓ Verified May 2026 Quality 19/100

Heptazone (generic name: PHENADOXONE) is a phenadoxone drug. It is currently in Phase 2 development.

Heptazone is believed to work by modulating opioid receptors.

Heptazone is a small molecule with synonyms including CB-11 FREE BASE, FENADOXONA, HEPTAZONE, IDS-NP-005, MORPHODONE, and PHENADOXONE. Its exact mechanism and clinical uses are not specified in the provided information.

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	PHENADOXONE
Drug class	phenadoxone
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your body has a lockbox that controls pain and feelings of well-being. Heptazone is thought to fit into this lockbox and adjust the way it works, helping to reduce pain and discomfort. However, the exact details of how it fits into the lockbox and what it does once inside are not yet fully understood.

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:

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

Frequently asked questions about Heptazone

What is Heptazone?

Heptazone (PHENADOXONE) is a phenadoxone drug.

How does Heptazone work?

Heptazone is believed to work by modulating opioid receptors.

What is the generic name of Heptazone?

PHENADOXONE is the generic (nonproprietary) name of Heptazone.

What drug class is Heptazone in?

Heptazone belongs to the phenadoxone class. See all phenadoxone drugs at /class/phenadoxone.

What development phase is Heptazone in?

Heptazone is in Phase 2.

Drug class: All phenadoxone drugs
Therapeutic area: All drugs in Pain

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