# Inclisiran (Leqvio)

Product · id `cardio:leqvio` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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Also called: Leqvio

Browse, condition area: Coronary and vascular disease  

## In plain language

Leqvio is the brand name of inclisiran, a small interfering RNA medicine that a health professional gives by injection to lower LDL cholesterol. The US FDA first approved it in December 2021. Its outcome trial, ORION-4, has not reported results.

## Technical summary

FDA application NDA214012, applicant Novartis (Drugs@FDA); original approval status date 2021-12-22. The current openFDA label record is version 13, effective 2026-08-19, and its manufacturer field reads Novartis Pharmaceuticals Corporation. The label describes inclisiran as an siRNA that directs breakdown of the messenger RNA for PCSK9. The label lists the use as lowering LDL-C and does not report an inclisiran outcomes result.

## Claims, with the population each applies to

## Context: United States FDA approval record NDA214012 for LEQVIO

Recipient: Recipient not specified; Population: Set by the product label. The Drugs@FDA application record names the product and applicant and gives no population; the current label states the indications.; Care setting: Prescription medicine, given by injection (Drugs@FDA route field); Geography: United States (decision by the US Food and Drug Administration); Life stage: See the label indications; not stated in the application record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)

### The US Food and Drug Administration approved LEQVIO (inclisiran) under new drug application NDA214012. The Drugs@FDA record lists an original submission (number 1, class Type 1 - New Molecular Entity) with approval status AP dated 22 December 2021, and NOVARTIS as the applicant. The current label states that LEQVIO is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, in heterozygous familial hypercholesterolemia from age 12, and in children aged 12 and older with homozygous familial hypercholesterolemia.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: Recipient: Recipient not specified; Population: Set by the product label. The Drugs@FDA application record names the product and applicant and gives no population; the current label states the indications.; Care setting: Prescription medicine, given by injection (Drugs@FDA route field); Geography: United States (decision by the US Food and Drug Administration); Life stage: See the label indications; not stated in the application record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)
- Limitations: openFDA says its data is unvalidated and not for medical decisions. The approval date is the status date of the original submission in the Drugs@FDA record, written as 20211222 there. The indications are those of the current label (version 13, effective 2026-08-19), which have changed since 2021 through supplements, so they are not the 2021 indications. The label also says cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events in adults at increased risk treated with statins or monoclonal antibody PCSK9 inhibitors; it does not say that LEQVIO itself has shown this, and this record does not claim it (the ORION-4 trial, which tests inclisiran, had not reported when this record was written). This record states the decision and the label wording only.
- Last checked: 2026-10-14
- Sources:
  1. Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012>
     Locator: results\[0\].application\_number: "NDA214012". Retrieved 2026-10-14T18:22:03Z. Source state: Current. Snapshot hash: 9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c.
     How it applies: Application number of this record.
  2. Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012>
     Locator: results\[0\].products\[0\].brand\_name: "LEQVIO". Retrieved 2026-10-14T18:22:03Z. Source state: Current. Snapshot hash: 9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c.
     How it applies: Brand name.
  3. Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012>
     Locator: results\[0\].sponsor\_name: "NOVARTIS". Retrieved 2026-10-14T18:22:03Z. Source state: Current. Snapshot hash: 9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c.
     How it applies: Applicant as the record writes it.
  4. Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012>
     Locator: results\[0\].submissions\[0\].submission\_type: "ORIG". Retrieved 2026-10-14T18:22:03Z. Source state: Current. Snapshot hash: 9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c.
     How it applies: Original submission.
  5. Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012>
     Locator: results\[0\].submissions\[0\].submission\_status: "AP". Retrieved 2026-10-14T18:22:03Z. Source state: Current. Snapshot hash: 9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c.
     How it applies: Approval status AP.
  6. Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012>
     Locator: results\[0\].submissions\[0\].submission\_status\_date: "20211222". Retrieved 2026-10-14T18:22:03Z. Source state: Current. Snapshot hash: 9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c.
     How it applies: Status date of the original submission, as eight digits.
  7. Supports: Drugs@FDA overview page for NDA214012 (Regulator, edition Page fetched 2026-10-14. It writes the approval date as month, day, year with slashes; the openFDA JSON writes the same date as eight digits.) <https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214012>
     Locator: Original Approvals or Tentative Approvals table, row ORIG-1. Retrieved 2026-10-14T18:35:14Z. Source state: Current. Snapshot hash: e373b8e2adf9c57a2ddcc4530e68aeb7c64b1abbb4c1f1b5d567815c4bb96a2a.
     How it applies: Drugs@FDA page, original approval date written with slashes.
  8. Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012>
     Locator: results\[0\].submissions\[0\].submission\_class\_code\_description: "Type 1 - New Molecular Entity". Retrieved 2026-10-14T18:22:03Z. Source state: Current. Snapshot hash: 9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c.
     How it applies: Submission class.
  9. Supports: LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44) (Label, edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13.) <https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6fc0afca-4513-4c35-b594-6544aee29a44>
     Locator: results\[0\].indications\_and\_usage\[0\]: "1 INDICATIONS AND USAGE LEQVIO ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:". Retrieved 2026-10-14T18:22:13Z. Source state: Current. Snapshot hash: 58e7283ce7a643577b6766337f70c3e7877adf1c139f4d23da7ec6ce0a01fd06.
     How it applies: Label indications, first part (version 13, effective 2026-08-19).
  10. Supports: LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44) (Label, edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13.) <https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6fc0afca-4513-4c35-b594-6544aee29a44>
     Locator: results\[0\].indications\_and\_usage\[0\]: "adults with hypercholesterolemia. adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). pediatric patients aged 12 years and older". Retrieved 2026-10-14T18:22:13Z. Source state: Current. Snapshot hash: 58e7283ce7a643577b6766337f70c3e7877adf1c139f4d23da7ec6ce0a01fd06.
     How it applies: Label indications, second part.
  11. Supports: LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44) (Label, edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13.) <https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6fc0afca-4513-4c35-b594-6544aee29a44>
     Locator: results\[0\].indications\_and\_usage\[0\]: "with homozygous familial hypercholesterolemia (HoFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE)". Retrieved 2026-10-14T18:22:13Z. Source state: Current. Snapshot hash: 58e7283ce7a643577b6766337f70c3e7877adf1c139f4d23da7ec6ce0a01fd06.
     How it applies: Label indications, third part.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-leqvio-nda214012`

- Product: Inclisiran (Leqvio) (`cardio:leqvio`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2021-12-22
- Product version: LEQVIO (inclisiran) injection, original application
- Pathway: NDA
- Submission: NDA214012
- Indication: Not read from the original approval. The 2021 label was not fetched. The current label wording (version 13, 2026-08-19) is in the linked claim; it includes uses that may have been added after 2021.
- Jurisdictions: United States; note: United States
- Applies to: Recipient: Recipient not specified; Population: Set by the product label. The Drugs@FDA application record names the product and applicant and gives no population; the current label states the indications.; Care setting: Prescription medicine, given by injection (Drugs@FDA route field); Geography: United States (decision by the US Food and Drug Administration); Life stage: See the label indications; not stated in the application record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)
- Basis: claim `cardio:claim-fda-leqvio-nda214012-approval`

## Connected pages

- Active ingredient: Inclisiran (`cardio:inclisiran`)
- Manufacturer field of the openFDA label record; the NDA applicant is also Novartis: Novartis (`cardio:novartis`)
- Files under this front: Medicines (`cardio:front-medicines`)

## Provenance

Content hash: 726fa63d6a8e3f2ff388ad1119f712140ed8e4d8a06e6ab380e8bafde02cf492
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14