Last reviewed 2026-05-20 · How we verify

Gabapral

Azienda Ospedaliera "Sant'Andrea" · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Gabapral is a Small molecule drug developed by Azienda Ospedaliera "Sant'Andrea". It is currently in Phase 1 development.

Gabapral is being studied as a potential treatment for pediatric irritable bowel syndrome (IBS) and fibromyalgia, according to a randomized controlled trial registered on ClinicalTrials.gov. The exact mechanism of Gabapral is not specified in the provided information, but it is being compared to a placebo in the trial.

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	Gabapral
Sponsor	Azienda Ospedaliera "Sant'Andrea"
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

Bifidobacterium Adolescentis PRL2019 in Pediatric Irritable Bowel Siyndrome: a Randomized Controlled Trial (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:

Gabapral CI brief — competitive landscape report
Gabapral updates RSS · CI watch RSS
Azienda Ospedaliera "Sant'Andrea" portfolio CI

Frequently asked questions about Gabapral

What is Gabapral?

Gabapral is a Small molecule drug developed by Azienda Ospedaliera "Sant'Andrea".

Who makes Gabapral?

Gabapral is developed by Azienda Ospedaliera "Sant'Andrea" (see full Azienda Ospedaliera "Sant'Andrea" pipeline at /company/azienda-ospedaliera-sant-andrea).

What development phase is Gabapral in?

Gabapral is in Phase 1.

Manufacturer: Azienda Ospedaliera "Sant'Andrea" — full pipeline
Therapeutic area: All drugs in Other

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