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Compound · clinical trials

Illuccix clinical trials

Also listed in trial records as 68Ga-PSMA-11, AAA517, Gallium Ga 68 Gozetotide
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 10 trials in our USA, Canada, Germany, France, Spain, China, Poland, Czechia, UK, Netherlands, Belgium, Sweden, Switzerland, Austria, South Korea, Singapore, Italy, Israel, Denmark, Mexico, Japan, Taiwan, Brazil and Australia registers that name Illuccix as an intervention. Synced 29 Sep 2026
10Current trials
3Recruiting now
6Lead sponsors
24Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Illuccix is named as an intervention in 10 current clinical trials in our USA, Canada, Germany, France, Spain, China, Poland, Czechia, UK, Netherlands, Belgium, Sweden, Switzerland, Austria, South Korea, Singapore, Italy, Israel, Denmark, Mexico, Japan, Taiwan, Brazil and Australia registers. 3 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Novartis Pharmaceuticals (4). The most-studied condition is Prostatic Neoplasm.

Where Illuccix is approved

All regulators →

Of the three regulators tracked here, the first to approve Illuccix was the US, on 1 Dec 2020.

USUnited States (FDA)
1 Dec 2020
Gallium Ga 68 Gozetotide
NDA212642 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Illuccix patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Illuccix, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Gozellix, Illuccix, Locametz
  • 3 listed patents; the last listed expires 9 Mar 2036 (US 12109277).
  • Latest patent on the drug substance itself: 15 Aug 2028 (US 11369590).
See the Orange Book listing for NDA 219592
Patents and exclusivities above are pooled across 5 applications for this substance.

Reproduced from the FDA Orange Book and Purple Book (checked 28 Sep 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

Trials by status

  • Recruiting330%
  • Not yet open110%
  • Active, closed660%

Trials by phase

  • Phase 3330%
  • Phase 2220%
  • Not applicable220%
  • Phase 2/3110%
  • Phase 1/2110%
  • Observational110%
01

Clinical trials of Illuccix

10 trials
StudyPhaseStatusLead sponsorRegisters
PSMA PET Combined With MRI for the Detection of PCa
NCT07052214 · ClinicalTrials.gov ↗ · PCA, Prostate Cancer, Prostatic Neoplasm
Phase 3 Recruiting Telix Pharmaceuticals (Innovations) Pty Limited USA, Australia
68Ga-PSMA-11 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI
NCT07209878 · ClinicalTrials.gov ↗ · Prostate Cancer (Adenocarcinoma)
Phase 2/3 Recruiting First Affiliated Hospital of Fujian Medical University China
68Ga-P16-093 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Primary Prostate Cancer Patients
NCT05324332 · ClinicalTrials.gov ↗ · Prostate Cancer
Not applicable Recruiting Peking Union Medical College Hospital China
68Ga-PSMA-11 PET/MRI for Selecting Men With Prostate Cancer for Focal Therapy
NCT07747493 · ClinicalTrials.gov ↗ · Prostate Cancer (Adenocarcinoma), Localized Prostate Cancer
Not applicable Not yet open University Health Network, Toronto Canada
177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
NCT04689828 · ClinicalTrials.gov ↗ · Prostatic Neoplasms
Phase 3 Active, closed Novartis Pharmaceuticals UK, USA, Germany, France, Spain, Netherlands, Belgium, Sweden, Poland, Switzerland, Austria, Czechia, Canada, Israel
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
NCT04720157 · ClinicalTrials.gov ↗ · Prostatic Neoplasms
Phase 3 Active, closed Novartis Pharmaceuticals UK, USA, China, Germany, France, Spain, Netherlands, Belgium, Sweden, Denmark, Poland, Switzerland, Austria, Czechia, Canada, Mexico, Japan, South Korea, Taiwan, Singapore
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
NCT05849298 · ClinicalTrials.gov ↗ · Prostatic Neoplasm
Phase 2 Active, closed Novartis Pharmaceuticals USA, Germany, France, Spain, Italy, Poland, Czechia, Canada, Brazil, South Korea, Singapore
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
NCT06004661 · ClinicalTrials.gov ↗ · Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Phase 2 Active, closed Novartis Pharmaceuticals USA, Germany, France, Spain, Italy
Prospective Clinical Trial of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
NCT07117760 · ClinicalTrials.gov ↗ · Prostate Cancer
Phase 1/2 Active, closed First Affiliated Hospital of Fujian Medical University China
[68Ga]Ga-PSMA-11 PET/CT in the Assessment of High Risk and Recurrent Prostate Cancer
NCT04484701 · ClinicalTrials.gov ↗ · Prostatic Neoplasm, Prostatic Cancer
Observational Active, closed British Columbia Cancer Agency Canada

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Illuccix

9 conditions
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Novartis Pharmaceuticals4
First Affiliated Hospital of Fujian Medical University2
Telix Pharmaceuticals (Innovations) Pty Limited1
Peking Union Medical College Hospital1
University Health Network, Toronto1
British Columbia Cancer Agency1
04

By country register

RegisterTrialsRecruiting
Clinical trials in USA51
Clinical trials in Canada50
Clinical trials in Germany40
Clinical trials in France40
Clinical trials in Spain40
Clinical trials in China42
Clinical trials in Poland30
Clinical trials in Czechia30
Clinical trials in UK20
Clinical trials in Netherlands20
Clinical trials in Belgium20
Clinical trials in Sweden20
Clinical trials in Switzerland20
Clinical trials in Austria20
Clinical trials in South Korea20
Clinical trials in Singapore20
Clinical trials in Italy20
Clinical trials in Israel10
Clinical trials in Denmark10
Clinical trials in Mexico10
Clinical trials in Japan10
Clinical trials in Taiwan10
Clinical trials in Brazil10
Clinical trials in Australia11

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Illuccix trials

How many clinical trials are testing Illuccix?

10 current trials in our USA, Canada, Germany, France, Spain, China, Poland, Czechia, UK, Netherlands, Belgium, Sweden, Switzerland, Austria, South Korea, Singapore, Italy, Israel, Denmark, Mexico, Japan, Taiwan, Brazil and Australia registers name Illuccix (also registered as 68Ga-PSMA-11) as a drug or biological intervention, as of the registry sync on 29 September 2026. Completed and withdrawn studies are not counted.

Are Illuccix trials recruiting patients?

Yes. 3 of the 10 trials are recruiting: 1 with sites in USA, 2 with sites in China and 1 with sites in Australia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Illuccix clinical trials?

Novartis Pharmaceuticals (4), First Affiliated Hospital of Fujian Medical University (2), Telix Pharmaceuticals (Innovations) Pty Limited (1) and Peking Union Medical College Hospital (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Illuccix works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Illuccix works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Illuccix (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 29 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.