CLINICAL TRIALS PROFILE FOR LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

All Clinical Trials for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05113537 ↗	Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer	Not yet recruiting	Eli Lilly and Company	Phase 1/Phase 2	2021-12-31	This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.
NCT05113537 ↗	Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer	Not yet recruiting	Prostate Cancer Foundation	Phase 1/Phase 2	2021-12-31	This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.
NCT05113537 ↗	Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer	Not yet recruiting	University of California, San Francisco	Phase 1/Phase 2	2021-12-31	This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.
NCT05682443 ↗	Phase 2 Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC	Not yet recruiting	Prostate Cancer Clinical Trials Consortium	Phase 2	2023-05-01	The goal of this clinical trial is to examine the safety and efficacy of ONC-392 in combination with lutetium Lu 177 vipivotide tetraxetan in metastatic castration resistant prostate cancer patient who have disease progressed on androgen receptor pathway inhibition. The main questions it aims to answer are (1) whether it is safe to combine ONC-392 with lutetium Lu 177 vipivotide tetraxetan, (2) whether the combination increases the radiographic progression free survival (rPFS). Participants will be randomized to two arms in 2:1 ratio. In experimental arm, they will be given ONC-392 10 mg/kg IV infusion, once every 4 weeks for up to 13 cycles or approximately one year, together with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles. In active control arm, they will be given standard of care treatment with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles.
NCT05682443 ↗	Phase 2 Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC	Not yet recruiting	OncoC4, Inc.	Phase 2	2023-05-01	The goal of this clinical trial is to examine the safety and efficacy of ONC-392 in combination with lutetium Lu 177 vipivotide tetraxetan in metastatic castration resistant prostate cancer patient who have disease progressed on androgen receptor pathway inhibition. The main questions it aims to answer are (1) whether it is safe to combine ONC-392 with lutetium Lu 177 vipivotide tetraxetan, (2) whether the combination increases the radiographic progression free survival (rPFS). Participants will be randomized to two arms in 2:1 ratio. In experimental arm, they will be given ONC-392 10 mg/kg IV infusion, once every 4 weeks for up to 13 cycles or approximately one year, together with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles. In active control arm, they will be given standard of care treatment with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles.

Clinical Trial Conditions for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Condition Name

Condition Name for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Intervention	Trials
Stage IVB Prostate Cancer AJCC v8	6
Castration-Resistant Prostate Carcinoma	5
Metastatic Castration-Resistant Prostate Cancer	4
Metastatic Prostate Adenocarcinoma	2

Condition MeSH

Condition MeSH for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Intervention	Trials
Prostatic Neoplasms	12
Carcinoma	2
Prostatic Neoplasms, Castration-Resistant	1
Carcinoma, Adenoid Cystic	1

Clinical Trial Locations for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Trials by Country

Trials by Country for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Location	Trials
United States	46
Australia	9
Spain	7
Switzerland	2
Canada	2

Trials by US State

Trials by US State for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Location	Trials
California	7
Nebraska	3
Virginia	2
Arizona	2
Missouri	2

Clinical Trial Progress for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Clinical Trial Phase

Clinical Trial Phase for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Clinical Trial Phase	Trials
PHASE2	9
PHASE1	3
Phase 4	1

Clinical Trial Status

Clinical Trial Status for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Clinical Trial Phase	Trials
Recruiting	10
Not yet recruiting	5
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Sponsor Name

Sponsor Name for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Sponsor	Trials
Novartis Pharmaceuticals	9
National Cancer Institute (NCI)	3
Jonsson Comprehensive Cancer Center	2

Sponsor Type

Sponsor Type for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Sponsor	Trials
Industry	16
Other	12
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Lutetium Lu-177 Vipivotide Tetraxetan

Last updated: October 26, 2025

Introduction

Lutetium Lu-177 vipivotide tetraxetan (trade name: Pluvicto®) emerges as a pivotal radioligand therapy targeting prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Approved by the U.S. Food and Drug Administration (FDA) in March 2022, this theranostic agent capitalizes on targeted radiation to improve patient outcomes. Understanding its current clinical trial landscape, market dynamics, and future projection is essential for stakeholders in oncology therapeutics, biotech investments, and healthcare policy.

Clinical Trials Landscape

Current Status and Ongoing Studies

Following FDA approval, clinical development aims to expand the indications and optimize therapeutic regimens. The pivotal Phase III VISION trial [1], which evaluated efficacy and safety in mCRPC patients previously treated with androgen receptor pathway inhibitors and chemotherapy, demonstrated a significant improvement in overall survival (OS) and radiographic progression-free survival (rPFS). Its robust data underpin today’s market authorization.

Apart from the VISION trial, several ongoing studies explore:

• Combination therapies: Evaluating lutetium-177 vipivotide tetraxetan with PARP inhibitors, immune checkpoint inhibitors, and androgen deprivation therapy to enhance efficacy.

• Earlier disease stages: Trials investigating use in non-metastatic castration-resistant prostate cancer or potential benefits in castration-sensitive settings.

• Dose optimization and safety profiles: Studies assessing long-term effects and optimal dosing regimens to minimize toxicity.

Key Trials

Trial Name	Phase	Focus	Enrollment	Expected Completion	Status
LU002	III	Combination with PD-1 inhibitors	600+	2024	Ongoing
LU003	II	Earlier disease stage	250	2023	Recruiting
NCT04445981	I/II	Dose escalation	60	2023	Completed

Regulatory Developments and Approvals

Following the VISION trial, regulatory agencies in Europe (EMA), Japan (PMDA), and other regions are evaluating submissions. The European approval was granted in late 2022, expanding access beyond the U.S. market. Additional approvals hinge on ongoing data demonstrations and post-marketing studies.

Market Analysis

Market Size and Growth Drivers

Prostate cancer remains one of the most prevalent malignancies among men globally, with an estimated 1.4 million new cases in 2020 [2]. The subset of mCRPC, especially in advanced lines post-AR pathway inhibitors and chemotherapy, accounts for a significant segment, estimated at over 250,000 patients worldwide annually.

The radiopharmaceuticals market, valued at approximately $1.1 billion in 2022 and expected to grow at a CAGR of 8% through 2030, is increasingly adopting targeted radionuclide therapy (TRT). Lutetium-based therapies notably capture investor interest due to their precision and favorable safety profile compared to conventional systemic chemotherapies.

Competitive Landscape

While lutetium-177 vipivotide tetraxetan is pioneering in PSMA-targeted TRT, competitors include:

• Alpha-emitting radioligands: Bismuth-213 and Actinium-225 compounds, presently under trials.

• Non-radiolabeled agents: Chemotherapies and immunotherapies for mCRPC.

However, the specificity and clinical efficacy demonstrated by Pluvicto® position it as a leading agent in PSMA-targeted TRT.

Market Penetration and Adoption Barriers

Physician familiarity with radioligand therapy remains limited, compounded by infrastructure constraints such as the need for specialized facilities and trained personnel. Additionally, reimbursement pathways are still evolving, with CMS coverage decisions influencing adoption in the U.S.

Regional Market Dynamics

• United States: Early adoption driven by FDA approval, managed care reimbursement strategies, and growing awareness.
• Europe: Pending national authorizations, with some countries like Germany and France initiating early access programs.
• Asia and Rest of World: Emerging markets with expanding prostate cancer prevalence, yet limited access due to regulatory and infrastructural issues.

Revenue Forecasts and Projections

Market research predicts that global sales of lutetium-177 vipivotide tetraxetan will reach $600 million to $1 billion by 2025, contingent upon approved indications expansion, clinical adoption rates, and reimbursement landscape improvements [3].

Key growth factors include:

• Expanding clinical trial results demonstrating benefits in earlier disease stages.
• Increasing awareness and physician education.
• Supportive policies favoring targeted therapies over systemic chemotherapy.

Potential risks and challenges involve:

• Competition from emerging PSMA-based agents and alternative therapies.
• Manufacturing scalability issues.
• Safety concerns, especially regarding long-term radiation exposure.

Future Outlook and Projection

The trajectory of lutetium Lu-177 vipivotide tetraxetan's market is promising, underpinned by ongoing clinical trials and expanding indications. By 2030, integrating combination regimens and earlier intervention strategies could multiply its market share exponentially. Continued innovation and regulatory support will be critical.

Key factors influencing future growth include:

• Early-line therapy approval: Demonstration of superior efficacy in earlier disease stages could expand use.
• Partnerships and collaborations: Pharmaceutical alliances with radiopharmaceutical manufacturers may improve supply chain robustness.
• Healthcare infrastructure: Investments in nuclear medicine facilities and training will accelerate adoption.

Projections indicate that global revenues for PSMA-targeted TRT could surpass $2 billion annually by 2030, assuming sustained clinical success and favorable reimbursement conditions.

Regulatory and Commercialization Strategy Recommendations

• Invest in academic collaborations to generate real-world evidence.
• Engage with payers early to establish clear reimbursement pathways.
• Expand manufacturing capacity aligned with global demand.
• Focus on physician education to facilitate clinical adoption.

Key Takeaways

• Lutetium Lu-177 vipivotide tetraxetan, approved based on robust Phase III data, represents a paradigm shift in mCRPC management.
• Ongoing trials exploring combination therapies and earlier interventions will likely expand its indications.
• The global market for PSMA-targeted radioligand therapy is poised for significant growth, reaching over $2 billion by 2030.
• Adoption hurdles, including infrastructure and reimbursement, require targeted strategic planning.
• Emerging competitors and long-term safety data will influence market dynamics.

FAQs

1. What makes lutetium Lu-177 vipivotide tetraxetan a breakthrough therapy for prostate cancer?
It offers targeted radiation delivery to PSMA-expressing prostate cancer cells, improving survival outcomes with manageable toxicity, marking a significant advance over conventional therapies.

2. Are there ongoing trials to expand its use beyond mCRPC?
Yes, multiple studies are investigating its potential in earlier disease stages and in combination with other therapies to improve efficacy.

3. What are the main challenges facing its widespread adoption?
Key challenges include limited infrastructure for radioligand administration, reimbursement complexities, and physician familiarity.

4. How is the global regulatory landscape evolving for this drug?
Following FDA approval, European authorities have granted authorization, with other regions evaluating submissions. Regulatory pathways will be influenced by regional study results and safety data.

5. What is the long-term outlook for this therapy in prostate cancer treatment?
With ongoing clinical development and expanding indications, lutetium Lu-177 vipivotide tetraxetan is poised to become a cornerstone in prostate cancer management, with potential to be integrated into earlier treatment algorithms.

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References

[1] [Lutetium Lu-177 vipivotide tetraxetan (Pluvicto®) FDA approval announcement.]
[2] Globocan 2020 Cancer Registry Data. International Agency for Research on Cancer.
[3] MarketResearch.com, "Global Radiopharmaceuticals Market Forecast," 2022.