Last reviewed 2026-04-19 · How we verify

NYR-BI03

Nyrada Pty Ltd · Phase 1 active Small molecule

NYR-BI03 is a Small molecule drug developed by Nyrada Pty Ltd. It is currently in Phase 1 development. Also known as: Xolatryp.

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	NYR-BI03
Also known as	Xolatryp
Sponsor	Nyrada Pty Ltd
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 Study of the Safety, Tolerability, and Pharmacokinetics of NYR-BI03 in Healthy Participants (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:

NYR-BI03 CI brief — competitive landscape report
NYR-BI03 updates RSS · CI watch RSS
Nyrada Pty Ltd portfolio CI

Frequently asked questions about NYR-BI03

What is NYR-BI03?

NYR-BI03 is a Small molecule drug developed by Nyrada Pty Ltd.

Who makes NYR-BI03?

NYR-BI03 is developed by Nyrada Pty Ltd (see full Nyrada Pty Ltd pipeline at /company/nyrada-pty-ltd).

Is NYR-BI03 also known as anything else?

NYR-BI03 is also known as Xolatryp.

What development phase is NYR-BI03 in?

NYR-BI03 is in Phase 1.

Manufacturer: Nyrada Pty Ltd — full pipeline
Also known as: Xolatryp

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