Last reviewed 2026-06-02 · How we verify

cyclamax

Persee Medica · Phase 1 active Small molecule ✓ Verified Jun 2026

cyclamax is a Small molecule drug developed by Persee Medica. It is currently in Phase 1 development.

Cyclamax is a food supplement that has been studied in a randomized, double-blind, placebo-controlled trial for its effect on sleep quality in patients with primary insomnia. The trial, registered on ClinicalTrials.gov as NCT00484497, aimed to evaluate the efficacy of cyclamax in improving sleep quality in individuals with insomnia.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	cyclamax
Sponsor	Persee Medica
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

cyclamax CI brief — competitive landscape report
cyclamax updates RSS · CI watch RSS
Persee Medica portfolio CI

Frequently asked questions about cyclamax

What is cyclamax?

cyclamax is a Small molecule drug developed by Persee Medica.

Who makes cyclamax?

cyclamax is developed by Persee Medica (see full Persee Medica pipeline at /company/persee-medica).

What development phase is cyclamax in?

cyclamax is in Phase 1.

Manufacturer: Persee Medica — full pipeline
Therapeutic area: All drugs in Other

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