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  1. pharmadog
  2. ›drugs
  3. ›Leqvio
drug · oligonucleotide
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inclisiran

Marketedupdated 5mo ago
by $NVS NOVARTIS AG🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval32 co-mentions · 8 sources
  • drugLEQVIO32 co-mentions · 8 sources

Oligonucleotide drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 6 investigational indications.

indications

investigational
Hyperlipidemia

targets

PCSK9 mRNA

all catalysts(8)

approval · 8
Dec 22, 2021
approval
$NVS141.00-0.04%
5y ago
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Jun 6, 2022
approval
$NVS141.00-0.04%
4y ago
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Feb 17, 2023
approval
$NVS141.00-0.04%
4y ago
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Jul 7, 2023
approval
$NVS141.00-0.04%
3y ago
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Jun 6, 2024
approval
$NVS141.00-0.04%
2y ago
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Jul 31, 2025
approval
$NVS141.00-0.04%
1y ago
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Feb 12, 2026
approval
$NVS141.00-0.04%
8mo ago
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Feb 12, 2026
approval
$NVS141.00-0.04%
8mo ago
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
view all 8 catalysts →

Trials studying inclisiran

  • phase4Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Interventionrecruitingn=6,000
  • phase3Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studiesrecruitingn=195
  • —Low-Density Lipoprotein Cholesterol Reduction With Alirocumab 150 mg Versus Inclisiran in Individuals Initiating Therapy in Routine Clinical Practicecompletedn=996
  • phase2Phase 2 Clinical Study of MWX203 Injection Alone or in Combination With Inclisiran Sodium Injection in Patients With Mixed Dyslipidemiarecruitingn=216
  • phase3A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.active not recruitingn=14,012
  • phase3Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Diseaseactive not recruitingn=17,004
  • phase1Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulationrecruitingn=120
  • —Specified Drug-use Survey of Leqvio for s.c. Injection.active not recruitingn=585

Patent cliff

source: FDA Orange Book
first barrier falls
Dec 22, 2026
78 days

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

patents (10)

  • Aug 25, 2036method-of-use (U-4249)US 10851377
  • Aug 18, 2034compositionUS 10125369
  • Aug 18, 2034compositionUS 12460206
  • Dec 12, 2029compositionUS 81060223.2y
  • Dec 4, 2028compositionUS 108067912.2y
  • Dec 4, 2028compositionUS 88289562.2y
  • Dec 4, 2028compositionUS 93705822.2y
  • Aug 24, 2028compositionUS 101319071.9y
  • Dec 29, 2027method-of-use (U-4414)US 82222221.2y
  • May 10, 2027compositionUS 8809292217d

FDA exclusivities (3)

  • Feb 12, 2029I-985Indication (3y)2.4y
  • Feb 12, 2029NPPNew Product (3y)2.4y
  • Dec 22, 2026NCENew Chemical Entity (5y)78d

News(7)

  • Novartis shareholder calls for board overhaul following costly deal setbacks: Reuters
    Novartis’ recent dual clinical setbacks have prompted questions from a major shareholder about the board’s oversight of dealmaking.
    fiercebiotech · 24d ago
  • Scribe’s early-stage IPO standout defies biotech’s derisking trend
    Scribe Therapeutics’ one-time epigenetic treatment is designed to slash the adherence burden of chronic cholesterol-lowering therapies while sidestepping the irreversibility of gene editing.
    biospace · 1mo ago
  • Scribe’s Benjamin Oakes on a rare IPO and bringing CRISPR to the masses
    The CEO spoke with BioPharma Dive about convincing investors to buy into the first gene editing IPO in more than two years.
    biopharma_dive · 1mo ago
  • Scribe records upsized $129M IPO to bankroll lipid-lowering genetic meds
    In vivo gene editing outfit Scribe Therapeutics has priced its IPO at $128.7 million, surpassing the $96 million goal set out earlier this week.
    fiercebiotech · 2mo 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 · 2mo ago
  • Scribe aims for $96M IPO to fund clinical push for lipid-lowering genetic meds
    Scribe Therapeutics has put its IPO plans down on paper, showing the genetic medicine company hopes to raise $96 million through its public listing.
    fiercebiotech · 2mo ago
  • Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor
    Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.
    biospace · 2mo ago
brand
Leqvio
generic
inclisiran
MOA
PCSK9 mRNA RNAi inhibitor
indication
Hyperlipidemia
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 1h ago
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