Last reviewed 2026-05-28 · How we verify

Surgiguard

Seoul National University Hospital · Phase 3 active Small molecule ✓ Verified May 2026

Surgiguard is a Small molecule drug developed by Seoul National University Hospital. It is currently in Phase 3 development. Also known as: laparoscopic unilateral ovarian cystectomy.

Surgiguard is a treatment being studied in a clinical trial for ovarian cysts. The purpose of this trial is to evaluate the safety and effectiveness of Surgiguard during laparoscopic ovarian cystectomy.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Surgiguard
Also known as	laparoscopic unilateral ovarian cystectomy
Sponsor	Seoul National University Hospital
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy (PHASE3)

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:

Surgiguard CI brief — competitive landscape report
Surgiguard updates RSS · CI watch RSS
Seoul National University Hospital portfolio CI

Frequently asked questions about Surgiguard

What is Surgiguard?

Surgiguard is a Small molecule drug developed by Seoul National University Hospital.

Who makes Surgiguard?

Surgiguard is developed by Seoul National University Hospital (see full Seoul National University Hospital pipeline at /company/seoul-national-university-hospital).

Is Surgiguard also known as anything else?

Surgiguard is also known as laparoscopic unilateral ovarian cystectomy.

What development phase is Surgiguard in?

Surgiguard is in Phase 3.

Manufacturer: Seoul National University Hospital — full pipeline
Therapeutic area: All drugs in Other
Also known as: laparoscopic unilateral ovarian cystectomy

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