Public record

Alirocumab: the public record

3 tables from US federal sources. Latest data date: Nov 11, 2026.

Each table is computed from the named federal dataset as of its data date; the method is under each one.

Label

FDA label facts for alirocumab

The FDA label read for alirocumab (Praluent, application BLA125559) was last revised on 2026-07-16. It carries no boxed warning. Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.

FDA label facts for alirocumab: the figures
MeasureValueNote
Label revision date2026-07-16
Label readPraluentBLA125559, brand-name application
Boxed warningNo
Pregnancy sectionPresent
Lactation sectionPresent
Pediatric use sectionPresent
Geriatric use sectionPresent

Source: FDA drug label via openFDA, viewable on NIH DailyMed, data as of Nov 11, 2026

How this was calculated

Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.

Scope: One label: the newest prescription label for single-ingredient alirocumab from an original manufacturer

Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.

Download the data (CSV)

Medicare Part D

Medicare Part D spending on alirocumab

Medicare Part D spending on alirocumab products was $340.6M in 2024 across 442,806 claims, compared with $475.9M in 2023 (-28.4%). Average spending per claim was $769, before rebates.

Medicare Part D spending on alirocumab: the figures
MeasureValue
Total spending, 2024$340.6M
Total spending, 2023$475.9M
Change in spending, 2023 to 2024-28.4%
Claims (prescription fills), 2024442,806
Average spending per claim, 2024$769

Source: CMS, Medicare Part D Spending by Drug, data as of 2024

How this was calculated

Summed total spending and claims over every brand and generic row with this generic name in the CMS file, using the Overall manufacturer rows. Combination products excluded. Average per claim is spending divided by claims.

Scope: Every single-ingredient alirocumab product in Part D (Praluent Pen), 2024.

Gross drug cost before manufacturer rebates, so net cost is lower. Part D excludes some uses by law (for example erectile dysfunction, weight loss and hair growth), so claims reflect covered uses only. Compounded products are not included.

Download the data (CSV)

Clinical studies

Registered clinical studies of alirocumab

ClinicalTrials.gov lists 118 registered studies that name alirocumab as an intervention as of 2026-11-11. Of these, 14 are recruiting, 69 are completed and 35 are phase 3 studies.

Registered clinical studies of alirocumab: the figures
MeasureValue
Registered studies118
Recruiting now14
Not yet recruiting6
Completed69
Terminated, withdrawn or suspended8
Phase 3 (including phase 2/3)35
Phase 2 (including phase 1/2)15
Phase 118

Source: NIH National Library of Medicine, ClinicalTrials.gov, data as of Nov 11, 2026

How this was calculated

Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.

Scope: Studies whose intervention field matches alirocumab, any condition, any country, all statuses

A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.

Download the data (CSV)

Articles on Alirocumab