Long-Term Safety of New VMS Agents: What We Know So Far
Panelists discuss how long-term safety data for fezolinetant and elinzanetant remain unavailable, though short-term results show very positive outcomes with significantly higher efficacy than previous treatment options.
Episode 6
The following transcript has been edited for clarity, style, and length.
Tara K. Iyer, MD: We’ve discussed these medications quite a bit, but let's formally address the differences between fezolinetant and elinzanetant. While elinzanetant does not yet have formal FDA labeling, we have substantial data from the OASIS 1, OASIS 2, and preliminary OASIS 3 trials. What do we know so far about the long-term safety of these two therapies, and how do they compare?
Alexa Fiffick, DO, MBS, MSCP: The key takeaway is that we don’t have extensive long-term data yet. However, based on current findings, both medications appear to be safe options. The primary distinction is fezolinetant is associated with liver injury. Despite this, both drugs show significant improvement in vasomotor symptom control.
When comparing their efficacy—though not in a direct head-to-head study—fezolinetant and elinzanetant demonstrate about 75%–80% symptom improvement. This is notably higher than some other non-hormonal treatments, which typically yield a 40%–60% improvement. So far, we haven't identified many other significant side effects, making these promising options. However, we still need more data to fully understand their long-term safety profiles.
