Drugs / SLN124
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | UK (MHRA) | — | beta-thalassemia, myelodysplastic syndrome | 2019-03-27 | “Clinical Trial Application (CTA) for the Company’s lead candidate SLN124 has been submitted to the UK Medicines and Healthcare products Regulatory Agency” silence-therapeutics.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04559971 | Sep 2020 → Mar 2021 | — | Silence Therapeutics GmbH | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT04718844 | Apr 2021 → May 2023 | inherited hemoglobinopathy, myelodysplastic syndrome | Silence Therapeutics GmbH | Completed | No outcome recorded |
| Phase 1 | NCT04176653 | Aug 2019 → Sep 2021 | beta-thalassemia intermedia, myelodysplastic syndrome | Silence Therapeutics GmbH | Withdrawn | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05499013 | Jan 2023 → Sep 2026 overdue | acquired polycythemia vera | Silence Therapeutics GmbH | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2024-06-27 | Silence Therapeutics GmbH | Results Silence Therapeutics Announces Positive Results from Ongoing SANRECO Phase 1 Study of Divesiran in Polycythemia Vera Patients silence-therapeutics.com ↗
Divesiran eliminated the need for phlebotomy in all well-controlled patients following infrequent dosing and was well tolerated |
| 2023-04-04 | Silence Therapeutics GmbH | Results Silence Therapeutics Announces Publication in Blood Demonstrating Role for Iron Regulation in Polycythemia Vera silence-therapeutics.com ↗
today announced publication of human genomic and in vivo preclinical data linking iron regulation to polycythemia vera (PV) in the latest issue of Blood, the medical journal of the American Society of Hematology (ASH), linked here. |
| 2022-09-29 | Silence Therapeutics GmbH | Results Silence Therapeutics Announces Preliminary Single Dose Results from SLN124 Phase 1 Study in Patients with Thalassemia silence-therapeutics.com ↗
Following a single dose, there were no serious adverse events, severe treatment emergent adverse events (TEAEs) that were SLN124 related or TEAEs leading to withdrawal. |
| 2022-09-08 | Silence Therapeutics GmbH | Regulatory Silence Therapeutics Announces FDA Fast Track Designation for SLN124, a Novel Investigational siRNA Therapy for the Treatment of Polycythemia Vera silence-therapeutics.com ↗ |
| 2021-12-12 | Silence Therapeutics GmbH | Results New Data from SLN124 Healthy Volunteer Study Reinforce Broad Therapeutic Potential in Hematological Diseases silence-therapeutics.com ↗ |
| 2021-05-19 | Silence Therapeutics GmbH | Results Silence Therapeutics Announces Positive Data from GEMINI Phase 1 Study of SLN124 in Healthy Volunteers silence-therapeutics.com ↗ |
| 2020-09-08 | Silence Therapeutics GmbH | Regulatory Silence Therapeutics Provides Research and Development Update silence-therapeutics.com ↗
Silence’s wholly owned lead product candidate SLN360 for the treatment of cardiovascular disease associated with high Lipoprotein(a), or Lp(a), levels, has received approval from the Food and Drug Administration (FDA) for an Investigational New Drug (IND) application to start dose escalation studies in healthy volunteers and secondary prevention patients with elevated Lp(a). |
| 2019-03-27 | Silence Therapeutics GmbH | Regulatory Silence Therapeutics submits Clinical Trial Application for SLN124 silence-therapeutics.com ↗
today announces that a Clinical Trial Application (CTA) for the Company’s lead candidate SLN124 has been submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA). |
| 2019-01-15 | Silence Therapeutics GmbH | Regulatory SLN124 granted Orphan Drug Designation by EMA for the treatment of β-Thalassemia silence-therapeutics.com ↗ |
| 2018-06-15 | Silence Therapeutics GmbH | Results Silence Therapeutics Presents Data on Lead Programme SLN124 at 23rd Annual European Hematology Association Congress silence-therapeutics.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SLN124 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04176653 ↗ |
| Action | Inhibit | “silencing of the TMPRSS6 gene” PMID 37497888 ↗ Jul 2023 |
| Modality | Small interfering RNA (siRNA) | “GalNAc conjugated double stranded fully modified siRNA” NCT04176653 ↗ |
| Route | Subcutaneous | “administered subcutaneously” PMID 37497888 ↗ Jul 2023 |
| Target | TMPRSS6 | “silencing of the TMPRSS6 gene” PMID 37497888 ↗ Jul 2023 |