drug · protein
lutetium Lu 177 vipivotide tetraxetan
Marketedupdated 3mo agoby $NVS NOVARTIS AG🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 4Protein 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
$NVS150.88-0.55%
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approval
lutetium Lu 177 vipivotide tetraxetan
→
Mar 28, 2025
approval
$NVS150.88-0.55%
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approval
lutetium Lu 177 vipivotide tetraxetan
→
Mar 28, 2025
approval
$NVS150.88-0.55%
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approval
lutetium Lu 177 vipivotide tetraxetan
→
Apr 7, 2026
approval
$NVS150.88-0.55%
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 Disease
- phase2Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial
- phase2Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)
- phase2Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
- phase2Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma
- phase2ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
- EP1A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 23, 2027
220 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)220d
News(10)
- ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualmsThe FDA has denied ITM Isotopes Technologies’ lead pipeline candidate for a rare group of tumors due to qualms over the drug’s manufacturing.fiercebiotech · 4d ago
- J&J pharma leader to retire; Krystal slumps on gene therapy missJennifer 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 · 10d ago
- FDA expands Pluvicto label, making it available to most metastatic prostate cancer patientsThe 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 · 11d ago
- Curium strikes up to $8B deal for radiopharma rival LantheusMonths 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 · 11d ago
- Recon: AstraZeneca, BMS discuss merger; FDA broadens indication for Novartis’ PluvictoWelcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.raps · 12d ago
- Novartis scraps mid-stage radiopharma asset as Pluvicto soarsThe 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 · 23d ago
- Novartis climbs on upbeat drug sales as key readouts loomA 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 · 24d ago
- Novartis stays 'geography-agnostic' in dealmaking amid flurry of China dealsNovartis 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 · 24d 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 · 24d ago
- Radiopharma maker AdvanCell hauls in $315M for Pluvicto challengerAdvanCell 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
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