Cardiovascular Atlas
About
Menu

Inclisiran (Leqvio)

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.

Also called Leqvio

  • Product
  • In this atlas

Overview

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.

Product details

Type
Medicine
Model or formulation
LEQVIO (inclisiran) injection, 284 mg/1.5 mL single-dose prefilled syringe per the label
Version
Label version 13, effective 2026-08-19 (openFDA label record)

Intended-use sources

  1. Background LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44)

    Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13. · SPL set id: 6fc0afca-4513-4c35-b594-6544aee29a44

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-08-19
    Source state
    Current
    Snapshot hash
    58e7283ce7a643577b6766337f70c3e7877adf1c139f4d23da7ec6ce0a01fd06
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/cg-openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44.json.

Claims and evidence

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)
Eligibility: inclusion criteria not stated; exclusion criteria not stated
Included
None stated
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    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.

    Applies to Recipient not specified
    • 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.
    • Prescription medicine, given by injection (Drugs@FDA route field)
    • United States (decision by the US Food and Drug Administration)
    • See the label indications; not stated in the application record
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    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
    Next evidence check due
    Not scheduled
    Sources and citations (11)

    1. Supports Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · NDA: NDA214012

      Locator
      results[0].application_number: "NDA214012"
      How it applies
      Application number of this record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-NDA214012.json.

    2. Supports Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · NDA: NDA214012

      Locator
      results[0].products[0].brand_name: "LEQVIO"
      How it applies
      Brand name.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-NDA214012.json.

    3. Supports Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · NDA: NDA214012

      Locator
      results[0].sponsor_name: "NOVARTIS"
      How it applies
      Applicant as the record writes it.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-NDA214012.json.

    4. Supports Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · NDA: NDA214012

      Locator
      results[0].submissions[0].submission_type: "ORIG"
      How it applies
      Original submission.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-NDA214012.json.

    5. Supports Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · NDA: NDA214012

      Locator
      results[0].submissions[0].submission_status: "AP"
      How it applies
      Approval status AP.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-NDA214012.json.

    6. Supports Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · NDA: NDA214012

      Locator
      results[0].submissions[0].submission_status_date: "20211222"
      How it applies
      Status date of the original submission, as eight digits.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-NDA214012.json.

    7. Supports Drugs@FDA overview page for NDA214012

      Regulator · U.S. Food and Drug Administration (Drugs@FDA) · 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.

      Locator
      Original Approvals or Tentative Approvals table, row ORIG-1
      How it applies
      Drugs@FDA page, original approval date written with slashes.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e373b8e2adf9c57a2ddcc4530e68aeb7c64b1abbb4c1f1b5d567815c4bb96a2a
      Reuse basis
      The FDA website policies page (fetched as ch-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3, hash only) says that, unless otherwise noted, the contents of the FDA website (www.fda.gov) are not copyrighted and are in the public domain. This page is on the accessdata.fda.gov host of FDA; the policy page names www.fda.gov only, so the terms for this host are unverified and the source is cite_only: facts are stated in the atlas's own words, with no quoted span. The same Drugs@FDA data in the openFDA endpoint is released under CC0 (see the openFDA source). The raw page is committed at research/snapshots/cg-fda-daf-NDA214012.html.

    8. Supports Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · NDA: NDA214012

      Locator
      results[0].submissions[0].submission_class_code_description: "Type 1 - New Molecular Entity"
      How it applies
      Submission class.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-NDA214012.json.

    9. Supports LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13. · SPL set id: 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:"
      How it applies
      Label indications, first part (version 13, effective 2026-08-19).
      Retrieved
      Source effective date
      2026-08-19
      Source state
      Current
      Snapshot hash
      58e7283ce7a643577b6766337f70c3e7877adf1c139f4d23da7ec6ce0a01fd06
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/cg-openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44.json.

    10. Supports LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13. · SPL set id: 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"
      How it applies
      Label indications, second part.
      Retrieved
      Source effective date
      2026-08-19
      Source state
      Current
      Snapshot hash
      58e7283ce7a643577b6766337f70c3e7877adf1c139f4d23da7ec6ce0a01fd06
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/cg-openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44.json.

    11. Supports LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13. · SPL set id: 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)"
      How it applies
      Label indications, third part.
      Retrieved
      Source effective date
      2026-08-19
      Source state
      Current
      Snapshot hash
      58e7283ce7a643577b6766337f70c3e7877adf1c139f4d23da7ec6ce0a01fd06
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/cg-openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44.json.

Authorization

Regulatory decision: Inclisiran (Leqvio)

Applies to Recipient not specified
  • 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.
  • Prescription medicine, given by injection (Drugs@FDA route field)
  • United States (decision by the US Food and Drug Administration)
  • See the label indications; not stated in the application record
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
NDA
Submission
NDA214012
Jurisdictions
United States; note: United States
Product version
LEQVIO (inclisiran) injection, original application
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.
Basis
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.

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.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
cardio:leqvio
Content hash
726fa63d6a8e3f2ff388ad1119f712140ed8e4d8a06e6ab380e8bafde02cf492