Last reviewed 2026-04-20 · How we verify

Roxenan (PICILOREX)

Phase 2 active Small molecule

Roxenan (generic name: PICILOREX) is a picilorex drug. It is currently in Phase 2 development.

PICILOREX works by interacting with a specific target to produce a therapeutic effect.

PICILOREX, also known as Roxenan, is a small molecule drug in the picilorex class. Its original development is unclear, but it is currently owned by an unknown entity. The target and approved indications of PICILOREX are not specified. Its commercial status, including patent status and generic availability, is also unknown. Further information on its pharmacokinetics, such as half-life and bioavailability, is not available.

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	PICILOREX
Drug class	picilorex
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

In plain English, PICILOREX is designed to bind to a specific site on the body's cells, which helps to produce a desired outcome. This interaction can lead to changes in the way the body functions, ultimately resulting in a therapeutic effect. However, the exact details of how PICILOREX works are not publicly available.

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:

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

Frequently asked questions about Roxenan

What is Roxenan?

Roxenan (PICILOREX) is a picilorex drug.

How does Roxenan work?

PICILOREX works by interacting with a specific target to produce a therapeutic effect.

What is the generic name of Roxenan?

PICILOREX is the generic (nonproprietary) name of Roxenan.

What drug class is Roxenan in?

Roxenan belongs to the picilorex class. See all picilorex drugs at /class/picilorex.

What development phase is Roxenan in?

Roxenan is in Phase 2.

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

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