Last reviewed 2026-05-19 · How we verify

Part 1 KS101

Klotho Sciences Australia Pty Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

Part 1 KS101 is a Small molecule drug developed by Klotho Sciences Australia Pty Ltd.. It is currently in Phase 1 development.

A Phase 1 study, NCT07143331, assessed the safety and effects of single and multiple doses of KS101 in healthy volunteers, as well as in participants with Alzheimer Disease and Chronic Kidney Disease. The study compared KS101 to a placebo and involved a separate part with food, but the specific details of the study's findings are not provided in the given facts.

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	Part 1 KS101
Sponsor	Klotho Sciences Australia 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 Phase 1 Study to Assess the Safety and Effects of Single and Multiple Doses of KS101 in Healthy Volunteers (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:

Part 1 KS101 CI brief — competitive landscape report
Part 1 KS101 updates RSS · CI watch RSS
Klotho Sciences Australia Pty Ltd. portfolio CI

Frequently asked questions about Part 1 KS101

What is Part 1 KS101?

Part 1 KS101 is a Small molecule drug developed by Klotho Sciences Australia Pty Ltd..

Who makes Part 1 KS101?

Part 1 KS101 is developed by Klotho Sciences Australia Pty Ltd. (see full Klotho Sciences Australia Pty Ltd. pipeline at /company/klotho-sciences-australia-pty-ltd).

What development phase is Part 1 KS101 in?

Part 1 KS101 is in Phase 1.

Manufacturer: Klotho Sciences Australia Pty Ltd. — full pipeline

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