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

Marketedupdated 5mo 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
$NVS142.57-2.15%
5y ago
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approval
lutetium Lu 177 vipivotide tetraxetan
→
Mar 28, 2025
approval
$NVS142.57-2.15%
2y ago
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approval
lutetium Lu 177 vipivotide tetraxetan
→
Mar 28, 2025
approval
$NVS142.57-2.15%
2y ago
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approval
lutetium Lu 177 vipivotide tetraxetan
→
Apr 7, 2026
approval
$NVS142.57-2.15%
6mo 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
173 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 104062401.9y
  • Aug 15, 2028compositionUS 113181211.9y

FDA exclusivities (2)

  • Mar 28, 2028I-965Indication (3y)1.5y
  • Mar 23, 2027NCENew Chemical Entity (5y)173d

News(10)

  • 3 steps for taking on Novartis in radiopharma: Curium up first
    To successfully challenge Novartis on two planned fronts, Curium will need to overcome the unique challenges posed by radiopharmaceutical supply to get products to patients and win market share.
    biospace · 1d ago
  • Novartis bets up to $900M for radioligand therapy from China’s BoomRay
    Novartis is the current radiopharma leader with two FDA-approved therapies in Pluvicto and Lutathera.
    biospace · 7d ago
  • Novartis secures new radioligand in $900M deal as competition strengthens
    As an imposing new competitor begins to take shape, radiopharma leader Novartis has beefed up its pipeline by licensing a preclinical radioligand therapy from a specialist Chinese biotech.
    fiercebiotech · 8d ago
  • Western licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts
    Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
    biospace · 9d ago
  • Sleuth forecasts 2027 jump in Western license deals for Chinese radioligand therapies
    Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
    biospace · 9d ago
  • Telix buys ITM for $1.65B in ‘supercritical’ radiopharma M&A
    Aside from its manufacturing and distribution footprint, ITM Isotope Technologies Munich will give Telix Pharmaceuticals the late-stage ITM-11, being developed for gastroenteropancreatic neuroendoc…
    biospace · 9d ago
  • Telix buys ITM in bid to create a ‘radiopharmaceutical powerhouse’
    Worth $1.65 billion up front, the deal combines two large pipelines and manufacturing networks, helping Telix potentially “corner the industry” for radiopharmaceuticals, one analyst wrote.
    biopharma_dive · 9d ago
  • Analysts ‘extremely bullish’ as Telix beams into Novartis’ territory with $1.6B ITM acquisition
    Telix has struck a deal to buy ITM Isotope Technologies Munich for $1.65 billion upfront, securing an R&D pipeline led by a rival to Novartis’ Lutathera and a radiopharmaceutical supply network.
    fiercebiotech · 9d ago
  • Novartis’ board faces investor scrutiny after M&A misfires and R&D flops
    Back-to-back failures of multiple late-phase trials have raised questions about how Novartis has deployed capital in pursuit of drugs to drive growth through the 2030s.
    biospace · 20d ago
  • A winner, a loser, and a mid-stage signal from a major cardiology research conference
    The mental health system after Lindsay Clancy, pushing boundaries for new radiopharmaceuticals, and more health news from Morning Rounds
    stat · 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 3h ago
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