Last reviewed 2026-04-19 · How we verify

Paromomycin Sulfate Fed State

KU Leuven · Phase 1 active Small molecule

Paromomycin Sulfate Fed State is a Small molecule drug developed by KU Leuven. It is currently in Phase 1 development. Also known as: Ensure Plus shake will be given 20 minutes before intake of paromomycin sulfate..

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	Paromomycin Sulfate Fed State
Also known as	Ensure Plus shake will be given 20 minutes before intake of paromomycin sulfate.
Sponsor	KU Leuven
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit (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:

Paromomycin Sulfate Fed State CI brief — competitive landscape report
Paromomycin Sulfate Fed State updates RSS · CI watch RSS
KU Leuven portfolio CI

Frequently asked questions about Paromomycin Sulfate Fed State

What is Paromomycin Sulfate Fed State?

Paromomycin Sulfate Fed State is a Small molecule drug developed by KU Leuven.

Who makes Paromomycin Sulfate Fed State?

Paromomycin Sulfate Fed State is developed by KU Leuven (see full KU Leuven pipeline at /company/ku-leuven).

Is Paromomycin Sulfate Fed State also known as anything else?

Paromomycin Sulfate Fed State is also known as Ensure Plus shake will be given 20 minutes before intake of paromomycin sulfate..

What development phase is Paromomycin Sulfate Fed State in?

Paromomycin Sulfate Fed State is in Phase 1.

Manufacturer: KU Leuven — full pipeline
Also known as: Ensure Plus shake will be given 20 minutes before intake of paromomycin sulfate.

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