Last reviewed 2026-04-19 · How we verify

HRS-5041 dose level 2

Atridia Pty Ltd. · Phase 1 active Small molecule

HRS-5041 dose level 2 is a Small molecule drug developed by Atridia Pty Ltd.. It is currently in Phase 1 development. Also known as: HRS-5041 (single dose, oral administration, dose level 2).

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	HRS-5041 dose level 2
Also known as	HRS-5041 (single dose, oral administration, dose level 2)
Sponsor	Atridia 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

Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male 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:

HRS-5041 dose level 2 CI brief — competitive landscape report
HRS-5041 dose level 2 updates RSS · CI watch RSS
Atridia Pty Ltd. portfolio CI

Frequently asked questions about HRS-5041 dose level 2

What is HRS-5041 dose level 2?

HRS-5041 dose level 2 is a Small molecule drug developed by Atridia Pty Ltd..

Who makes HRS-5041 dose level 2?

HRS-5041 dose level 2 is developed by Atridia Pty Ltd. (see full Atridia Pty Ltd. pipeline at /company/atridia-pty-ltd).

Is HRS-5041 dose level 2 also known as anything else?

HRS-5041 dose level 2 is also known as HRS-5041 (single dose, oral administration, dose level 2).

What development phase is HRS-5041 dose level 2 in?

HRS-5041 dose level 2 is in Phase 1.

Manufacturer: Atridia Pty Ltd. — full pipeline
Also known as: HRS-5041 (single dose, oral administration, dose level 2)

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