Last reviewed 2026-05-28 · How we verify

Sopodorm

Silesian University of Medicine · Phase 1 active Small molecule ✓ Verified May 2026

Sopodorm is a Small molecule drug developed by Silesian University of Medicine. It is currently in Phase 1 development.

Sopodorm is a medication that has been studied in clinical trials for the management of postoperative pain. It has been compared to paravertebral blockade (PVB) and propofol WZF in a study on thoracic paravertebral block in postoperative pain management after renal surgery.

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	Sopodorm
Sponsor	Silesian University of Medicine
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

Thoracic Paravertebral Block in Pain Management After Renal Surgery (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:

Sopodorm CI brief — competitive landscape report
Sopodorm updates RSS · CI watch RSS
Silesian University of Medicine portfolio CI

Frequently asked questions about Sopodorm

What is Sopodorm?

Sopodorm is a Small molecule drug developed by Silesian University of Medicine.

Who makes Sopodorm?

Sopodorm is developed by Silesian University of Medicine (see full Silesian University of Medicine pipeline at /company/silesian-university-of-medicine).

What development phase is Sopodorm in?

Sopodorm is in Phase 1.

Manufacturer: Silesian University of Medicine — full pipeline
Therapeutic area: All drugs in Other

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