drug · oligonucleotide
inclisiran
Marketedupdated 3mo agoby $NVS NOVARTIS AG🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 2Oligonucleotide 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
$NVS150.88-0.55%
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
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Jun 6, 2022
approval
$NVS150.88-0.55%
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
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Feb 17, 2023
approval
$NVS150.88-0.55%
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
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Jul 7, 2023
approval
$NVS150.88-0.55%
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
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Jun 6, 2024
approval
$NVS150.88-0.55%
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Jul 31, 2025
approval
$NVS150.88-0.55%
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Feb 12, 2026
approval
$NVS150.88-0.55%
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Feb 12, 2026
approval
$NVS150.88-0.55%
LEQVIO (INCLISIRAN SODIUM) — FDA approval
inclisiran
→
Trials studying inclisiran
- phase3Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
- phase1Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
- —Specified Drug-use Survey of Leqvio for s.c. Injection.
- phase3Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
- phase4Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
- phase3Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
- phase3Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
- phase4A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Patent cliff
source: FDA Orange Bookfirst barrier falls
Dec 22, 2026
129 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 81060223.3y
- Dec 4, 2028compositionUS 108067912.3y
- Dec 4, 2028compositionUS 88289562.3y
- Dec 4, 2028compositionUS 93705822.3y
- Aug 24, 2028compositionUS 101319072.0y
- Dec 29, 2027method-of-use (U-4414)US 82222221.4y
- May 10, 2027compositionUS 8809292268d
FDA exclusivities (3)
- Feb 12, 2029I-985Indication (3y)2.5y
- Feb 12, 2029NPPNew Product (3y)2.5y
- Dec 22, 2026NCENew Chemical Entity (5y)129d
News(5)
- Scribe’s Benjamin Oakes on a rare IPO and bringing CRISPR to the massesThe CEO spoke with BioPharma Dive about convincing investors to buy into the first gene editing IPO in more than two years.biopharma_dive · 4d ago
- Scribe records upsized $129M IPO to bankroll lipid-lowering genetic medsIn 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 · 22d 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
- Scribe aims for $96M IPO to fund clinical push for lipid-lowering genetic medsScribe Therapeutics has put its IPO plans down on paper, showing the genetic medicine company hopes to raise $96 million through its public listing.fiercebiotech · 25d ago
- Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitorMerck’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 · 29d ago
Data sources
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