Last reviewed 2026-05-29 · How we verify

SVG103

Sovargen · Phase 1 active Small molecule ✓ Verified May 2026

SVG103 is a Small molecule drug developed by Sovargen. It is currently in Phase 1 development. Also known as: paxalisib.

SVG103, also known as Paxalisib, is being studied in a clinical trial for its safety, tolerability, and pharmacokinetics in patients with Focal Cortical Dysplasia Type II, Tuberous Sclerosis Complex, or Hemimegalencephaly. This study, NCT07287202, is an open-label Phase 1b/2a trial conducted by Sovargen.

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	SVG103
Also known as	paxalisib
Sponsor	Sovargen
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME) (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:

SVG103 CI brief — competitive landscape report
SVG103 updates RSS · CI watch RSS
Sovargen portfolio CI

Frequently asked questions about SVG103

What is SVG103?

SVG103 is a Small molecule drug developed by Sovargen.

Who makes SVG103?

SVG103 is developed by Sovargen (see full Sovargen pipeline at /company/sovargen).

Is SVG103 also known as anything else?

SVG103 is also known as paxalisib.

What development phase is SVG103 in?

SVG103 is in Phase 1.

Manufacturer: Sovargen — full pipeline
Also known as: paxalisib

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