Sibeprenlimab
As of the edition of 20 October 2026, Sibeprenlimab is an antibody: marketed, first approved in 2025 (US); acts on TNFSF13; US protection ends in 2037.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Antibody
- Brand name
- Voyxact
- First approved
- 25 November 2025 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Otsuka
- Registered trials
- 7, 0 stopped early
- Disease areas
- Immune system; Pregnancy and women's health; Urinary and reproductive; Eye; Mouth and teeth
US protection
US protection ends in 2037.
US protection ends in 2037, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Otsuka. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Sibeprenlimab.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TNFSF13 | Tumor necrosis factor ligand superfamily member 13 | O75888 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 3 | 1 | 2 | 0 |
| Phase 3 | 2 | 0 | 2 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Originator and Lead sponsor of trials | 2018 to now |