NP031112

Noscira SA · Phase 1 active Small molecule

NP031112 is a Small molecule drug developed by Noscira SA. It is currently in Phase 1 development. Also known as: tideglusib, NP12.

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	NP031112
Also known as	tideglusib, NP12
Sponsor	Noscira SA
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy (PHASE2)
• Efficacy and Safety of Tideglusib in Congenital Myotonic Dystrophy (PHASE2, PHASE3)
• Study of Tideglusib in Adolescent and Adult Patients With Myotonic Dystrophy (PHASE2)
• Tideglusib: Expanded Access Use in Congenital Myotonic Dystrophy
• Tideglusib vs. Placebo in the Treatment of Adolescents With Autism Spectrum Disorders (PHASE2)
• Safety and Efficacy of Tideglusib in Congenital or Childhood Onset Myotonic Dystrophy (PHASE2, PHASE3)
• Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis (PHASE2)
• Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients (PHASE2)

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:

• NP031112 CI brief — competitive landscape report
• NP031112 updates RSS · CI watch RSS
• Noscira SA portfolio CI

Frequently asked questions about NP031112

What is NP031112?

NP031112 is a Small molecule drug developed by Noscira SA.

Who makes NP031112?

NP031112 is developed by Noscira SA (see full Noscira SA pipeline at /company/noscira-sa).

Is NP031112 also known as anything else?

NP031112 is also known as tideglusib, NP12.

What development phase is NP031112 in?

NP031112 is in Phase 1.

Related

• Manufacturer: Noscira SA — full pipeline
• Also known as: tideglusib, NP12