Last reviewed 2026-06-02 · How we verify

LEO 32731 API, hard capsule

LEO Pharma · Phase 1 active Small molecule ✓ Verified Jun 2026

LEO 32731 API, hard capsule is a Small molecule drug developed by LEO Pharma. It is currently in Phase 1 development.

LEO 32731 API is a small molecule. It is being investigated in a Phase 1 clinical trial to assess its safety, tolerability, and pharmacokinetics in healthy individuals.

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	LEO 32731 API, hard capsule
Sponsor	LEO Pharma
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Trial to Investigate the Safety, Tolerability, and Drug Levels in Blood After Single and Multiple Doses of LEO 32731 in Healthy People (PHASE1)

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:

LEO 32731 API, hard capsule CI brief — competitive landscape report
LEO 32731 API, hard capsule updates RSS · CI watch RSS
LEO Pharma portfolio CI

Frequently asked questions about LEO 32731 API, hard capsule

What is LEO 32731 API, hard capsule?

LEO 32731 API, hard capsule is a Small molecule drug developed by LEO Pharma.

Who makes LEO 32731 API, hard capsule?

LEO 32731 API, hard capsule is developed by LEO Pharma (see full LEO Pharma pipeline at /company/leo-pharma).

What development phase is LEO 32731 API, hard capsule in?

LEO 32731 API, hard capsule is in Phase 1.

Manufacturer: LEO Pharma — full pipeline

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