Last reviewed 2026-04-19 · How we verify

PERT at discharge

Sunnybrook Health Sciences Centre · Phase 1 active Small molecule

PERT at discharge is a Small molecule drug developed by Sunnybrook Health Sciences Centre. It is currently in Phase 1 development. Also known as: PrCREON MINIMICROSPHERES®25 or similar (PrCotazym® ECS, PrPANCREASE® MT, PrVIOKACE™).

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	PERT at discharge
Also known as	PrCREON MINIMICROSPHERES®25 or similar (PrCotazym® ECS, PrPANCREASE® MT, PrVIOKACE™)
Sponsor	Sunnybrook Health Sciences Centre
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

PERT at discharge CI brief — competitive landscape report
PERT at discharge updates RSS · CI watch RSS
Sunnybrook Health Sciences Centre portfolio CI

Frequently asked questions about PERT at discharge

What is PERT at discharge?

PERT at discharge is a Small molecule drug developed by Sunnybrook Health Sciences Centre.

Who makes PERT at discharge?

PERT at discharge is developed by Sunnybrook Health Sciences Centre (see full Sunnybrook Health Sciences Centre pipeline at /company/sunnybrook-health-sciences-centre).

Is PERT at discharge also known as anything else?

PERT at discharge is also known as PrCREON MINIMICROSPHERES®25 or similar (PrCotazym® ECS, PrPANCREASE® MT, PrVIOKACE™).

What development phase is PERT at discharge in?

PERT at discharge is in Phase 1.

Manufacturer: Sunnybrook Health Sciences Centre — full pipeline
Also known as: PrCREON MINIMICROSPHERES®25 or similar (PrCotazym® ECS, PrPANCREASE® MT, PrVIOKACE™)

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