Last reviewed 2026-05-20 · How we verify

Normacol

Assistance Publique - Hôpitaux de Paris · Phase 2 active Small molecule ✓ Verified May 2026

Normacol is a Small molecule drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 2 development. Also known as: hypertonic enema solution.

Normacol is a medication used in fecal transplantation for patients with melanoma, as per a clinical trial (NCT04988841). The exact mechanism of Normacol is not specified in the provided information, but it is being studied alongside other interventions for melanoma and Irritable Bowel Syndrome.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Normacol
Also known as	hypertonic enema solution
Sponsor	Assistance Publique - Hôpitaux de Paris
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

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:

Normacol CI brief — competitive landscape report
Normacol updates RSS · CI watch RSS
Assistance Publique - Hôpitaux de Paris portfolio CI

Frequently asked questions about Normacol

What is Normacol?

Normacol is a Small molecule drug developed by Assistance Publique - Hôpitaux de Paris.

Who makes Normacol?

Normacol is developed by Assistance Publique - Hôpitaux de Paris (see full Assistance Publique - Hôpitaux de Paris pipeline at /company/assistance-publique-h-pitaux-de-paris).

Is Normacol also known as anything else?

Normacol is also known as hypertonic enema solution.

What development phase is Normacol in?

Normacol is in Phase 2.

Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
Therapeutic area: All drugs in Other
Also known as: hypertonic enema solution

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