Last reviewed 2026-04-19 · How we verify

PRAX-222 - Initial Ascending Doses

Praxis Precision Medicines · Phase 1 active Small molecule

PRAX-222 - Initial Ascending Doses is a Small molecule drug developed by Praxis Precision Medicines. It is currently in Phase 1 development.

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	PRAX-222 - Initial Ascending Doses
Sponsor	Praxis Precision Medicines
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy (PHASE1, PHASE2)

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:

PRAX-222 - Initial Ascending Doses CI brief — competitive landscape report
PRAX-222 - Initial Ascending Doses updates RSS · CI watch RSS
Praxis Precision Medicines portfolio CI

Frequently asked questions about PRAX-222 - Initial Ascending Doses

What is PRAX-222 - Initial Ascending Doses?

PRAX-222 - Initial Ascending Doses is a Small molecule drug developed by Praxis Precision Medicines.

Who makes PRAX-222 - Initial Ascending Doses?

PRAX-222 - Initial Ascending Doses is developed by Praxis Precision Medicines (see full Praxis Precision Medicines pipeline at /company/praxis-precision-medicines).

What development phase is PRAX-222 - Initial Ascending Doses in?

PRAX-222 - Initial Ascending Doses is in Phase 1.

Manufacturer: Praxis Precision Medicines — full pipeline

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