drug · small molecule
lurbinectedin
Marketedupdated 3mo agoby $JAZZ Jazz Pharmaceuticals plc🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 2Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for neoplasm and small cell lung carcinoma and 9 investigational indications.
all catalysts(6)
approval · 6
Jun 15, 2020
approval
$JAZZ244.96-0.36%
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
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Apr 1, 2022
approval
$JAZZ244.96-0.36%
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
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Jul 28, 2023
approval
$JAZZ244.96-0.36%
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
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Apr 30, 2025
approval
$JAZZ244.96-0.36%
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
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Oct 2, 2025
approval
$JAZZ244.96-0.36%
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
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Feb 27, 2026
approval
$JAZZ244.96-0.36%
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
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Trials studying lurbinectedin
- phase3A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer
- phase3A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
- phase2A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer
- phase3Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)
- phase2A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
- phase2Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
- phase3Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)
- phase2Lurbinectedin + Doxorubicin In Leiomyosarcoma
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jun 15, 2027
304 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (4)
- May 29, 2040method-of-use (U-4212)US 12324806
- May 29, 2040method-of-use (U-4305)US 12433890
- May 29, 2040method-of-use (U-4252)US 12440490
- Dec 13, 2029compositionUS 77636153.3y
FDA exclusivities (2)
- Oct 2, 2028I-977Indication (3y)2.1y
- Jun 15, 2027ODE-304Orphan Drug (7y)304d
News(3)
- Recon: Lilly to broaden expanded access for unapproved obesity drug; Jazz to withdraw second-line SCLC indication for ZepzelcaWelcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.raps · 10d ago
- Enliven prices $400M offering; Jazz drug Zepzelca fails confirmatory studyPlus news about Caribou, Adial, and the Beneluxa Initiative. 💵 Enliven Therapeutics’ data and raise: The Burlingame, CA-based biotech priced a $400 million offering {$ELVN} Thursday night after sa…endpoints · 2mo ago
- Track the Lung Cancer Abstracts That are Gaining Attention at ASCO 2026Read on to see what data are poised to shape clinical discussions and decision-making in lung cancer at 2026 ASCO Annual Meeting in Chicago, Illinois.onclive · 3mo ago
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