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  1. pharmadog
  2. ›drugs
  3. ›Zepzelca
drug · small molecule
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lurbinectedin

Marketedupdated 5mo ago
by $JAZZ Jazz Pharmaceuticals plc🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval24 co-mentions · 6 sources
  • drugZEPZELCA24 co-mentions · 6 sources

Small 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
$JAZZ235.67+1.14%
6y ago
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
→
Apr 1, 2022
approval
$JAZZ235.67+1.14%
5y ago
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
→
Jul 28, 2023
approval
$JAZZ235.67+1.14%
3y ago
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
→
Apr 30, 2025
approval
$JAZZ235.67+1.14%
1y ago
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
→
Oct 2, 2025
approval
$JAZZ235.67+1.14%
1y ago
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
→
Feb 27, 2026
approval
$JAZZ235.67+1.14%
7mo ago
ZEPZELCA (LURBINECTEDIN) — FDA approval
lurbinectedin
→

Trials studying lurbinectedin

  • 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 Cancerrecruitingn=180
  • phase3BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)recruitingn=550
  • 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 Cancerrecruitingn=531
  • phase3A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Canceractive not recruitingn=660
  • 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)completedn=705
  • phase2Lurbinectedin in FET-Fused Tumorsrecruitingn=63
  • phase3A Study of ZL-1310 in Combination With a Checkpoint Inhibitor Versus Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancernot yet recruitingn=530
  • phase2Lurbinectedin + Doxorubicin In Leiomyosarcomaactive not recruitingn=62

Patent cliff

source: FDA Orange Book
first barrier falls
Jun 15, 2027
254 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 77636153.2y

FDA exclusivities (2)

  • Oct 2, 2028I-977Indication (3y)2.0y
  • Jun 15, 2027ODE-304Orphan Drug (7y)254d

News(4)

  • Roche, MediLink notch phase 3 lung cancer win but trail GSK on cross-trial survival
    MediLink has reported phase 3 results on a Roche-partnered antibody-drug conjugate. The small-cell lung cancer trial hit its primary endpoint, although the B7-H3-directed ADC’s median overall survi…
    fiercebiotech · 19d ago
  • Recon: Lilly to broaden expanded access for unapproved obesity drug; Jazz to withdraw second-line SCLC indication for Zepzelca
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 2mo ago
  • Enliven prices $400M offering; Jazz drug Zepzelca fails confirmatory study
    Plus 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 · 3mo ago
  • Track the Lung Cancer Abstracts That are Gaining Attention at ASCO 2026
    Read 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 · 4mo ago
brand
Zepzelca
trade names
Zepsyre, Zepzelca
generic
lurbinectedin
MOA
12.1 Mechanism of Action Lurbinectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death. Lurbinectedin inhibited human monocyte activity in vitro and reduced macrophage infiltration in implanted tumors in mice.
indication
Ewing Sarcoma
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 5m ago
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