Last reviewed 2026-04-20 · How we verify

Cyclazenine (GUANACLINE)

Phase 2 active Small molecule

Cyclazenine (generic name: GUANACLINE) is a guanacline drug. It is currently in Phase 2 development.

Guanacline is thought to work by interacting with specific receptors or enzymes in the body.

Cyclazenine, also known as Guanacline, is a small molecule drug in the guanacline class. Its target and exact mechanism of action are unknown, but it is believed to work by interacting with specific receptors or enzymes in the body. Guanacline is not FDA-approved for any indications, and its commercial status, patent status, and availability of generic manufacturers are also unknown. Further research is needed to understand its potential therapeutic applications and safety profile. As a result, key safety considerations and dosing information are currently unavailable.

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	GUANACLINE
Drug class	guanacline
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and Guanacline is a key that fits into those locks. When it binds to the lock, it can either turn it on or off, or change the way it works. This can affect how different cells in the body communicate with each other and respond to signals.

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:

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

Frequently asked questions about Cyclazenine

What is Cyclazenine?

Cyclazenine (GUANACLINE) is a guanacline drug.

How does Cyclazenine work?

Guanacline is thought to work by interacting with specific receptors or enzymes in the body.

What is the generic name of Cyclazenine?

GUANACLINE is the generic (nonproprietary) name of Cyclazenine.

What drug class is Cyclazenine in?

Cyclazenine belongs to the guanacline class. See all guanacline drugs at /class/guanacline.

What development phase is Cyclazenine in?

Cyclazenine is in Phase 2.

Drug class: All guanacline drugs
Therapeutic area: All drugs in Other

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