CLINICAL TRIALS PROFILE FOR PLUVICTO

All Clinical Trials for PLUVICTO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT06084338 ↗	Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc	Recruiting	VA Office of Research and Development	Phase 2	2023-12-14	This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.

Clinical Trial Conditions for PLUVICTO

Condition Name

Condition Name for PLUVICTO
Intervention	Trials
Metastatic Castration-resistant Prostate Cancer	2
Prostate Cancer	2
Prostate Cancer (CRPC)	1

Condition MeSH

Condition MeSH for PLUVICTO
Intervention	Trials
Prostatic Neoplasms	5

Clinical Trial Locations for PLUVICTO

Trials by Country

Trials by Country for PLUVICTO
Location	Trials
United States	9
Spain	3
Canada	1
Netherlands	1
China	1

Trials by US State

Trials by US State for PLUVICTO
Location	Trials
Texas	2
New Jersey	1
District of Columbia	1
Ohio	1
Georgia	1

Clinical Trial Progress for PLUVICTO

Clinical Trial Phase

Clinical Trial Phase for PLUVICTO
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for PLUVICTO
Clinical Trial Phase	Trials
RECRUITING	5
ENROLLING_BY_INVITATION	1
TERMINATED	1

Clinical Trial Sponsors for PLUVICTO

Sponsor Name

Sponsor Name for PLUVICTO
Sponsor	Trials
Novartis	2
Canadian Institutes of Health Research (CIHR)	1
CHU de Quebec-Universite Laval	1

Sponsor Type

Sponsor Type for PLUVICTO
Sponsor	Trials
Other	9
Industry	6
U.S. Fed	1

Last updated: July 30, 2026

PLUVICTO clinical trials update, market analysis, and forecast: what’s driving uptake, exclusivity, and revenue outlook (Lu-177 vipivotide tetraxetan)

Executive summary: PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is scaling after FDA approval for adults with unresectable or metastatic PSMA-positive miCRPC who have progressed after androgen receptor pathway inhibition and taxane chemotherapy. Key near-term drivers are expanding sequencing in miCRPC, increasing global center adoption for PSMA PET-based selection, and payer coverage as real-world dosing patterns stabilize. Primary risks are reimbursement pushback tied to imaging and administration costs, finite eligible patient pools once stratification tightens, and competitive pressure from PSMA-targeted radionuclides and emerging combinations. A practical revenue projection requires tying demand to PSMA PET screening rates, Lu-177 supply capacity, and time-to-treatment at PSMA PET centers.

Note: This update cannot be completed to the required Bloomberg-style, data-dense standard because no clinical-trials dataset, FDA label date, indication-by-indication status, revenue history, trial readouts, or competitive/in-market numbers were provided.

What clinical trials are ongoing for PLUVICTO (Lu-177 vipivotide tetraxetan) in miCRPC?

Featured snippet answer: PLUVICTO’s core evidence base is built on the pivotal VISION program in PSMA-positive miCRPC. The next phase of uptake depends on ongoing studies that test PLUVICTO earlier in the disease course, in combination regimens, and across PSMA-PET selection strategies. Without the specific trial list and current status, a precise “clinical trials update” with timelines and endpoints cannot be produced.

Which trial readouts matter most for sequencing?

• Overall survival and radiographic progression endpoints in PSMA-positive miCRPC
• PSA response and duration of response for real-world treatment modeling
• Safety signals tied to xerostomia, myelosuppression, and renal-dose exposure
• Imaging-based eligibility and inter-reader variability for PSMA PET thresholds

How do combination trials change uptake risk?

Combination trials can increase addressable patients and influence sequencing decisions, but they also raise:

• extra toxicity management complexity
• resource constraints on PSMA PET and radionuclide administration
• reimbursement hurdles when add-on value is not yet priced

How strong is the patent and regulatory position for PLUVICTO (Orange Book status and exclusivity)?

Featured snippet answer: PLUVICTO is a radioligand therapy; regulatory exclusivity and patent coverage typically protect active ingredient-related claims, dosing regimens, formulations/linkers, and manufacturing. A correct exclusivity and patent-expiration timeline requires the specific patent list and FDA exclusivity flags.

What FDA pathway governs PLUVICTO and what does it imply?

• Approval basis: pivotal randomized or controlled evidence in the labeled miCRPC population
• Label-driven exclusivity can be impacted by line-of-therapy scope and supplemental indications
• Radioligand manufacturing and formulation patents often create meaningful “procedural” barriers even after marketing authorization

What is PLUVICTO market size and revenue forecast for 2026–2035?

Featured snippet answer: The revenue trajectory is primarily a function of (1) PSMA PET availability and testing rates, (2) eligible patient pool size in miCRPC after AR pathway inhibitor and taxane, (3) dosing uptake and retreatment patterns, and (4) payer acceptance per treatment course. A numeric forecast requires the baseline (current units, country mix, ASP or reimbursement, and dosing per patient).

Demand model inputs that drive projections

To forecast PLUVICTO revenue in a litigation and licensing-ready way, analysts typically parameterize:

• PSMA PET penetration among miCRPC patients
• fraction of PSMA PET-confirmed patients eligible by radiographic and progression criteria
• proportion treated after failure of ARPI and taxane
• dose regimen adherence (cycles per patient, dose intensity constraints)
• supply constraints tied to radiopharmaceutical production and logistics

Unit economics and payer coverage constraints

Key financial drivers:

• per-cycle cost and total course cost including imaging and administration
• payer policies that separate “PET selection” cost from therapy cost
• site-of-care dynamics: hospital outpatient vs specialty infusion centers

How does PLUVICTO compare with competing PSMA radioligand therapies and what does that do to share?

Featured snippet answer: PLUVICTO competes in a crowded PSMA radionuclide and next-gen radiopharmaceutical landscape, where differentiation is driven by clinical outcomes by subgroup, safety profile, dosing logistics, and label scope by line of therapy. A share-impact analysis requires the competitor trial/label status and head-to-head positioning that is not provided.

What competitive axes decide share

• label breadth by prior therapies and PSMA PET selection rules
• tolerability and ability to maintain treatment in real-world myelosuppression
• ability to scale nationwide supply under radionuclide procurement constraints
• evidence strength for earlier lines or combination approaches

What generic or biosimilar entry risks exist for PLUVICTO?

Featured snippet answer: For radioligand therapies, “generic” risk differs from conventional small molecules. Competitive entry often depends on:

• manufacturing and radiolabeling process patents
• method-of-use claims tied to dosing regimens and patient selection
• regulatory pathway barriers for radiopharmaceutical equivalents

A credible entry-risk view requires identifying the patent thicket and the regulatory strategy of would-be entrants.

Key takeaways

• PLUVICTO demand growth hinges on real-world PSMA PET selection, line-of-therapy sequencing, and payer acceptance.
• Near-term market expansion is constrained by eligible miCRPC pool size, center adoption, and administration capacity.
• Patent and exclusivity assessment requires an exact FDA/Orange Book and patent list to build a litigation-grade timeline.
• A numeric revenue forecast from 2026 onward needs baseline units, pricing/reimbursement, country mix, and dosing patterns.

FAQs

1. What sequencing strategy best monetizes PLUVICTO in PSMA-positive miCRPC?
2. How does PSMA PET positivity threshold selection affect PLUVICTO eligible patient counts?
3. What are the key real-world safety management constraints for Lu-177 vipivotide tetraxetan?
4. Which radiopharmaceutical supply bottlenecks most impact PLUVICTO throughput by region?
5. How do payer prior authorization requirements typically structure coverage for PLUVICTO treatment courses?

References (APA)

No sources were provided in the prompt, so no citations can be listed.