Last reviewed 2026-05-19 · How we verify

ORY-2001 Low dose

Oryzon Genomics S.A. · Phase 2 active Small molecule ✓ Verified May 2026

ORY-2001 Low dose is a Small molecule drug developed by Oryzon Genomics S.A.. It is currently in Phase 2 development.

ORY-2001 is a small molecule being studied as a potential treatment for mild to moderate Alzheimer's disease. It is being investigated in a clinical trial as a low-dose intervention, along with a high-dose intervention and a placebo, to assess its safety and preliminary efficacy.

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	ORY-2001 Low dose
Sponsor	Oryzon Genomics S.A.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Testing the Safety and Preliminary Efficacy of the New Drug ORY-2001 in Mild to Moderate Alzheimer's Disease (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:

ORY-2001 Low dose CI brief — competitive landscape report
ORY-2001 Low dose updates RSS · CI watch RSS
Oryzon Genomics S.A. portfolio CI

Frequently asked questions about ORY-2001 Low dose

What is ORY-2001 Low dose?

ORY-2001 Low dose is a Small molecule drug developed by Oryzon Genomics S.A..

Who makes ORY-2001 Low dose?

ORY-2001 Low dose is developed by Oryzon Genomics S.A. (see full Oryzon Genomics S.A. pipeline at /company/oryzon-genomics-s-a).

What development phase is ORY-2001 Low dose in?

ORY-2001 Low dose is in Phase 2.

Manufacturer: Oryzon Genomics S.A. — full pipeline

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