Public record
Alirocumab: the public record
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.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2026-07-16 | |
| Label read | Praluent | BLA125559, brand-name application |
| Boxed warning | No | |
| Pregnancy section | Present | |
| Lactation section | Present | |
| Pediatric use section | Present | |
| Geriatric use section | Present |
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.
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.
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.
| Measure | Value |
|---|---|
| Total spending, 2024 | $340.6M |
| Total spending, 2023 | $475.9M |
| Change in spending, 2023 to 2024 | -28.4% |
| Claims (prescription fills), 2024 | 442,806 |
| Average spending per claim, 2024 | $769 |
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.
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.
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.
| Measure | Value |
|---|---|
| Registered studies | 118 |
| Recruiting now | 14 |
| Not yet recruiting | 6 |
| Completed | 69 |
| Terminated, withdrawn or suspended | 8 |
| Phase 3 (including phase 2/3) | 35 |
| Phase 2 (including phase 1/2) | 15 |
| Phase 1 | 18 |
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.
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.
Articles on Alirocumab
- How to Safely Stop Praluent (Alirocumab): Discontinuation Protocol
- Praluent Travel & Timezone-Shift Protocols: A Complete Clinical Guide
- Praluent Autoimmune Disease Considerations: What Clinicians Need to Know
- Praluent (Alirocumab): What to Expect Week by Week in Your First Month
- Praluent Hair and Skin Changes: What Alirocumab Actually Does to Your Integument
- Praluent Manufacturer Copay Program: How to Cut Your Alirocumab Costs in 2026