# Full-Life Technologies Announces U.S. FDA IND Clearance and Australian Regulatory Clearance for [²²⁵Ac]Ac-FL-261 Phase 1 Clinical Trial

- Link: https://www.thailand-business-news.com/pr-news/full-life-technologies-announces-u-s-fda-ind-clearance-and-australian-regulatory-clearance-for-%c2%b2%c2%b2%e2%81%b5acac-fl-261-phase-1-clinical-trial
- Published: 2026-09-09T19:25:00+07:00
- Author: PR Newswire

LONDON, Sept. 9, 2026 /PRNewswire/ — Full-Life Technologies ("Full-Life", the "Company"),
a privately held, fully integrated, clinical-stage actinium-based global radiopharmaceutical
company, today announced that the U.S. Food and Drug Administration ("FDA") has 
cleared the Company’s Investigational New Drug ("IND") application for [^(225)Ac]
Ac-FL-261 and that the program has received Australian Human Research Ethics Committee("
HREC") approval and completed the Clinical Trial Notification ("CTN") process with
Therapeutic Goods Administration ("TGA"). These clearances enable Full-Life to advance
a Phase 1 clinical trial of [^(225)Ac]Ac-FL-261 in the United States and Australia
in patients with c-MET-expressing non-squamous non-small cell lung cancer ("nsNSCLC").

"These regulatory clearances represent an important milestone for FL-261 and our
strategy to expand targeted alpha therapy into various solid tumors," **said Debora
Barton, MD, Chief Medical Officer of Full-Life Technologies.** "[^(225)Ac]Ac-FL-
261 is designed to selectively target c-MET-expressing tumors by delivering potent
alpha radiation directly into the tumor sites. We look forward to advancing FL-261
into its Phase 1 trial and generating key clinical evidence that will help translate
our preclinical findings and inform the continued development of this promising 
program."

The planned first-in-human Phase 1 study will evaluate the safety, tolerability,
pharmacokinetics and preliminary antitumor activity of [^(225)Ac]Ac-FL-261 in patients
with nsNSCLC. Full-Life plans to conduct clinical development in the United States,
Australia and other key regions.

**About [^(225)Ac]Ac-FL-261**

[^(225)Ac]Ac-FL-261 is Full-Life’s potential first-in-class c-MET-targeted alpha
radioconjugate for multiple solid tumor indications. It is designed to selectively
bind c-MET-expressing tumors and deliver alpha-particle radiation directly to tumor
cells. FL-261 is one of the various radiopharmaceutical assets developed utilizing
Full-Life’s proprietary UniRDC™ discovery platform.

**About UniRDC™**

UniRDC™ is Full-Life’s proprietary discovery platform which allows for rapid generation
of radiopharmaceutical development candidates with optimized therapeutic properties.
By integrating proprietary synthetic chemistry and protein-engineering capabilities,
UniRDC™ enables high and sustained tumor uptake in humans while avoiding key safety
organs, addressing two long-standing challenges in radiopharmaceutical chemistry.
The platform supports an accelerated path from target selection to a development
candidate with human biodistribution data in less than 24 months. UniRDC™ has been
dosed in over 100 patients, generated three clinical-stage assets to date and been
validated by multiple partnerships with strategic pharmaceutical partners.

**About Full-Life Technologies**

Full-Life Technologies ("Full-Life") is a privately held, fully integrated, clinical-
stage actinium-based global radiopharmaceutical company focused on developing next-
generation targeted radioconjugate for patients. Full-Life has three clinical-stage
programs: [^(225)Ac]Ac-FL-020, a PSMA-targeted alpha radioconjugate currently being
evaluated in a global Phase 1 trial for metastatic castration-resistant prostate
cancer (mCRPC); [^(225)Ac]Ac-FL-261, a potentially first-in-class c-MET-targeted
alpha radioconjugate being developed for multiple solid tumor indications, with 
an initial focus on non-squamous non-small cell lung cancer (nsNSCLC); and an NTSR1-
targeted small-molecule radioconjugate currently being evaluated in a Phase 1 clinical
trial under a collaboration with a strategic partner. The Company has fully integrated
capabilities spanning drug discovery, clinical development, Actinium-225 production,
and manufacturing, and has completed the construction of a state-of-the-art GMP-
compliant Ac-225 manufacturing and radiolabeling facility in Belgium. 

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