Last reviewed 2026-06-02 · How we verify

Norpseudoephedrine (CATHINE)

Phase 2 active Small molecule

Norpseudoephedrine (generic name: CATHINE) is a cathine drug. It is currently in Phase 2 development.

Norpseudoephedrine works by stimulating the central nervous system, increasing alertness and energy.

Norpseudoephedrine, also known as cathine, is a small molecule drug of the cathine class. Its original development and current ownership are not specified. The target of norpseudoephedrine is unknown, and it is not FDA-approved for any indications. As a result, there is limited information available on its commercial status, pharmacokinetics, or safety considerations. Further research is needed to fully understand this compound.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	CATHINE
Drug class	cathine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a busy office, and norpseudoephedrine is like a super-caffeine that helps keep the office workers (neurons) going all day long. It does this by increasing the amount of certain chemicals in the brain that help you feel more alert and awake. This can be helpful for people who need a energy boost, but it can also have negative effects if taken in excess.

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:

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

Frequently asked questions about Norpseudoephedrine

What is Norpseudoephedrine?

Norpseudoephedrine (CATHINE) is a cathine drug.

How does Norpseudoephedrine work?

Norpseudoephedrine works by stimulating the central nervous system, increasing alertness and energy.

What is the generic name of Norpseudoephedrine?

CATHINE is the generic (nonproprietary) name of Norpseudoephedrine.

What drug class is Norpseudoephedrine in?

Norpseudoephedrine belongs to the cathine class. See all cathine drugs at /class/cathine.

What development phase is Norpseudoephedrine in?

Norpseudoephedrine is in Phase 2.

Drug class: All cathine drugs
Therapeutic area: All drugs in Neuroscience

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