FDA Events for Silence Therapeutics (SLNCF)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Silence Therapeutics (SLNCF).
Over the past two years, Silence Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
zerlasiran. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
zerlasiran - FDA Regulatory Timeline and Events
zerlasiran is a drug developed by Silence Therapeutics for the following indication: In atherosclerotic cardiovascular disease (ASCVD) patients with high lipoprotein(a) [Lp(a)] levels (≥125 nmol/L).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- zerlasiran
- Announced Date:
- November 18, 2024
- Indication:
- In atherosclerotic cardiovascular disease (ASCVD) patients with high lipoprotein(a) [Lp(a)] levels (≥125 nmol/L).
Announcement
Silence Therapeutics today presented end-of-treatment data from its Phase 2 ALPACAR-360 study of zerlasiran, a short interfering RNA (siRNA), in atherosclerotic cardiovascular disease (ASCVD) patients with high lipoprotein(a) [Lp(a)] levels (≥125 nmol/L).
AI Summary
Silence Therapeutics presented end-of-treatment data today from its Phase 2 ALPACAR-360 study of zerlasiran, a short interfering RNA (siRNA) aimed at patients with atherosclerotic cardiovascular disease (ASCVD) who have high lipoprotein(a) levels (≥125 nmol/L). The study is the first to report time-averaged Lp(a) reductions that measure the treatment’s impact over longer periods, including the time between doses.
The results showed that different dosing regimens of zerlasiran (300 mg every 16 weeks, 300 mg every 24 weeks, or 450 mg every 24 weeks) led to more than 80% mean placebo-adjusted reduction in Lp(a) levels over 36 weeks, with maximum reductions exceeding 90%. Notably, these reductions persisted until the final visit 60 weeks after the first dose, and the treatment was well tolerated. These promising results will help guide the dosing strategy for upcoming Phase 3 trials.
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Silence Therapeutics FDA Events - Frequently Asked Questions
As of now, Silence Therapeutics (SLNCF) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Silence Therapeutics (SLNCF) has reported FDA regulatory activity for zerlasiran.
The most recent FDA-related event for Silence Therapeutics occurred on November 18, 2024, involving zerlasiran. The update was categorized as "Data," with the company reporting: "Silence Therapeutics today presented end-of-treatment data from its Phase 2 ALPACAR-360 study of zerlasiran, a short interfering RNA (siRNA), in atherosclerotic cardiovascular disease (ASCVD) patients with high lipoprotein(a) [Lp(a)] levels (≥125 nmol/L)."
Currently, Silence Therapeutics has one therapy (zerlasiran) targeting the following condition: In atherosclerotic cardiovascular disease (ASCVD) patients with high lipoprotein(a) [Lp(a)] levels (≥125 nmol/L)..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (OTCMKTS:SLNCF) was last updated on 7/9/2025 by MarketBeat.com Staff
