Telix Completes Illuccix Japan Phase 3 Enrollment
Telix Illuccix Japan Phase 3 enrollment is complete at 105 patients with biochemically recurrent prostate cancer after prostatectomy. Telix said on July 17, 2026 that the local registration study of TLX591-Px (68Ga-PSMA-11) will support a Japan NDA, while a Conditional Approval request remains under PMDA review.
Contents10 sections
Key Takeaways
- Telix completed enrollment of 105 patients across 11 Japan sites in the Illuccix Phase 3 registration study.
- Primary endpoint compares 68Ga-PSMA-11 PET/CT sensitivity versus CT and bone scan for metastases in BCR disease.
- Data are intended to support a Japan NDA; Conditional Approval is already under PMDA review.
- Prostate cancer is the most common cancer in Japanese men (>104,000 new cases yearly), per Telix.
Illuccix Japan Phase 3 at a glance
| Field | Detail |
|---|---|
| Product | TLX591-Px / Illuccix (kit for 68Ga-PSMA-11) |
| Company | Telix Pharmaceuticals (ASX/NASDAQ: TLX) |
| Study | Illuccix Japan Phase 3 (prospective, open-label, multicenter) |
| Enrollment | 105 patients completed (announced July 17, 2026) |
| Population | Biochemically recurrent prostate cancer after radical prostatectomy |
| Regulator path | Japan NDA planned; Conditional Approval under PMDA review |
| Sites | 11 centers in Japan |
What milestone did Telix announce?
Telix said patient enrollment is complete in the pivotal Phase 3 registration study of TLX591-Px (Illuccix) for prostate cancer imaging in Japanese patients. The product is a kit for preparing gallium-68 PSMA-11 for PET/CT.
Source: Telix's July 17 PR Newswire Japan enrollment release.
How is the Japan Phase 3 designed?
Illuccix Japan is a prospective, open-label, multicenter Phase 3 study in BCR prostate cancer after radical prostatectomy. The primary objective compares sensitivity of 68Ga-PSMA-11 PET/CT with conventional imaging modalities, including CT and bone scintigraphy, for metastatic lesion detection.
- Secondary: diagnostic performance for local and distant lesions
- Secondary: safety and tolerability
- Secondary: impact of imaging findings on clinical management decisions
What is the Japan regulatory path?
Telix is preparing an NDA for Japan using the local Phase 3 clinical dataset. In parallel, the company said its Conditional Approval application is under review by Japan's Pharmaceuticals and Medical Devices Agency. If granted, Conditional Approval would enable expedited NDA review while the final study dataset is prepared.
PMDA program context is covered in our earlier note on PMDA orphan portal and ASEAN device symposium.
How does this fit Telix's Japan prostate franchise?
Enrollment completion advances Illuccix registration in one of the world's largest nuclear-medicine markets. Telix also cited named-patient use for TLX591-Px in Japan and enrollment in the Phase 3 ProstACT Global study of therapeutic TLX591-Tx (lutetium-177 rosopatamab tetraxetan). Illuccix is already commercial in 22 countries including the U.S., the company said.
Recent commercial context: Telix Q2 revenue and pipeline update. ASX-listed disclosures are filed via ASX market announcements.
What remains uncertain?
Enrollment completion is not a readout. Sensitivity deltas versus conventional imaging, false-positive rates, and management-change rates will only appear when top-line results are released. Conditional Approval timing and final NDA action dates are unknown. Therapeutic TLX591-Tx remains a separate registrational program.
Related NovaPharma coverage
- Asia-Pacific medical radioisotopes supply TGA
- PMDA Approves New Pharmaceuticals and Medical Devices
- PMDA approves ENHERTU for HER2-low breast cancer in Japan
Frequently Asked Questions
What study enrollment did Telix complete in Japan?
On July 17, 2026, Telix said it completed enrollment of 105 patients in the pivotal Phase 3 Illuccix Japan study of TLX591-Px (68Ga-PSMA-11) PET/CT in Japanese men with biochemically recurrent prostate cancer after radical prostatectomy.
What is the primary goal of the Illuccix Japan Phase 3 trial?
The primary objective is to compare the sensitivity of 68Ga-PSMA-11 PET/CT with conventional imaging (CT and bone scintigraphy) for detecting metastatic lesions. Secondary goals include local/distant diagnostic performance, safety, and impact on clinical management.
How does this relate to PMDA filing plans?
Telix said the Phase 3 dataset will support a Japan NDA for TLX591-Px. In parallel, a Conditional Approval application is under PMDA review; if granted, it could expedite NDA review while the final clinical dataset is prepared.
Primary Sources
Regulatory catalyst tracker
Track PDUFA dates, approval milestones, and label updates for Illuccix.
Unlock full calendar →Telix Pharmaceuticals pipeline snapshot
One-screen view of active programs, phases, and recent catalysts from public sources.
Investor brief
Download a one-page summary of regulatory impact and competitive context.
Explore drug hub →Entity graph
Continue Exploring
Open the drugs, companies, and topics behind this story.
This article follows our editorial standards. Report a correction via editorial contact.
Deeper reading
Industry reports & whitepapers
- La Negoziazione del Prezzo dei Farmaci Oncologici in Italia — This whitepaper analyzes the market benchmark role in negotiating oncology drug prices in Italy, hig…
- Cytological Specimens in the Molecular Era of Metastatic Melanoma — This whitepaper discusses the role of cytological specimens in diagnosing metastatic melanoma and th…