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  1. pharmadog
  2. ›drugs
  3. ›Pluvicto
drug · protein
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lutetium Lu 177 vipivotide tetraxetan

Marketedupdated 3mo ago
by $NVS NOVARTIS AG🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • drugPLUVICTO12 co-mentions · 5 sources
  • tagApproval10 co-mentions · 5 sources
  • tagOncology4 co-mentions · 1 sources
  • tagProstate Cancer4 co-mentions · 1 sources

Protein drug with a maximum clinical stage of Approval (across all indications), with an approval for prostate cancer and 6 investigational indications.

targets

Glutamate carboxypeptidase 2

all catalysts(4)

approval · 4
Mar 23, 2022
approval
$NVS156.24-2.54%
4y ago
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approval
lutetium Lu 177 vipivotide tetraxetan
→
Mar 28, 2025
approval
$NVS156.24-2.54%
1y ago
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approval
lutetium Lu 177 vipivotide tetraxetan
→
Mar 28, 2025
approval
$NVS156.24-2.54%
1y ago
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approval
lutetium Lu 177 vipivotide tetraxetan
→
Apr 7, 2026
approval
$NVS156.24-2.54%
5mo ago
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approval
lutetium Lu 177 vipivotide tetraxetan
→

Trials studying lutetium Lu 177 vipivotide tetraxetan

  • phase2Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Diseaserecruitingn=51
  • phase2Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trialrecruitingn=40
  • phase2Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)recruitingn=90
  • phase2Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancerrecruitingn=15
  • phase2Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinomarecruitingn=107
  • phase2ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPCactive not recruitingn=148
  • EP1A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancerterminatedn=17

Patent cliff

source: FDA Orange Book
first barrier falls
Mar 23, 2027
214 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (5)

  • Sep 18, 2041method-of-use (U-4169)US 12208102
  • Nov 12, 2035method-of-use (U-4169)US 11951190
  • Oct 17, 2034compositionUS 10398791
  • Aug 15, 2028compositionUS 104062402.0y
  • Aug 15, 2028compositionUS 113181212.0y

FDA exclusivities (2)

  • Mar 28, 2028I-965Indication (3y)1.6y
  • Mar 23, 2027NCENew Chemical Entity (5y)214d

News(10)

  • ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualms
    The FDA has denied ITM Isotopes Technologies’ lead pipeline candidate for a rare group of tumors due to qualms over the drug’s manufacturing.
    fiercebiotech · 10d ago
  • J&J pharma leader to retire; Krystal slumps on gene therapy miss
    Jennifer Taubert will step down after a lengthy run leading J&J’s pharmaceutical business. Elsewhere, pricing issues hampered what Wall Street analysts view as an otherwise strong gene therapy launch.
    biopharma_dive · 16d ago
  • FDA expands Pluvicto label, making it available to most metastatic prostate cancer patients
    The FDA approved Novartis’ radiopharma drug Pluvicto for use alongside hormone therapy, making the drug available to many more patients. The approval nearly doubles the eligible patient population…
    endpoints · 17d ago
  • Curium strikes up to $8B deal for radiopharma rival Lantheus
    Months after reports first linked Curium to a potential Lantheus takeover, the radiopharma players have made it official with a deal worth up to $8 billion.
    fiercebiotech · 17d ago
  • Recon: AstraZeneca, BMS discuss merger; FDA broadens indication for Novartis’ Pluvicto
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 18d ago
  • Novartis scraps mid-stage radiopharma asset as Pluvicto soars
    The discontinued asset, being trialed for breast cancer and solid tumors, had yielded disappointing data, leading to Novartis’ decision to abandon development, according to a company spokesperson.
    biospace · 29d ago
  • Novartis climbs on upbeat drug sales as key readouts loom
    A return to quarterly sales growth boosted shares higher on Tuesday, though a handful of coming study results will have a bigger impact on the company’s long-term outlook.
    biopharma_dive · 1mo ago
  • Novartis stays 'geography-agnostic' in dealmaking amid flurry of China deals
    Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma's second quarter earnings call—though major pickups aren’t completely o…
    biospace · 1mo ago
  • Novartis drops phase 2 radioligand therapy, but CEO’s commitment to modality ‘unchanged’
    Novartis has dropped a phase 2-stage radioligand therapy after the candidate disappointed in the clinic.
    fiercebiotech · 1mo ago
  • Radiopharma maker AdvanCell hauls in $315M for Pluvicto challenger
    AdvanCell raised a $315 million Series D to study a lead-based prostate cancer agent and shore up its US manufacturing of the radioactive treatment. The round marks one of the largest yet for a rad…
    endpoints · 1mo ago
view all news mentions →
brand
Pluvicto
trade names
Pluvicto
generic
lutetium Lu 177 vipivotide tetraxetan
MOA
Glutamate carboxypeptidase II binding agent
indication
Hormone-Sensitive Prostate Cancer
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 26m ago
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