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Hot flashing right now. Hot flashing. You are, too, you angel. Do you have sweat going down your crack? You do? Yeah. I do, too. I love that. Do you have sweat going down your crack? Me too. This poor comedian, she does such a great job talking about the perils and the true discomfort of perimenopausal and menopausal hot flashes. As I've said many times before, God bless you, women. It's no doubt the stronger of the two sexes because, my goodness, I am the. The true model of having a man cold. All right, can I just tell you that, I mean, the world, like, stops on its axis when I get a man cold. And I don't. I can't even imagine if men had hot flashes. I mean, literally, I mean, the world would catch on fire. I mean, it would just. There's no way. So God bless you women for the struggle of the hot flash. I know it is a pain. Speaking of the man cold, there was this, this hilarious little British clip. The guy is lying in bed, he's like, I called for you. I called for you. You didn't come. So, you know, he calls 91 1. You ever heard of this? Hey, man, the man cold is real under the weather. How are you feeling? How do you think I feel, you stupid cold, Haven't I? Thanks a lot. Poor darling. You should have said something. I'd have come down and made you some soup. I called for you. I said, lara, Lara, you didn't come. So I dialed 999. No. Yeah, so in this clip, what's going on? We're here, 999 is 911, and I go, you know what's going on? It's like, I've got a man cold. Like, oh, my God, no, it's not a man cold. So anyway, all to say, if men suffered from hot flashes, we would all be screwed. So that is very loosely, very loosely tied in to our topic today because thank goodness for anything on the scene, anything on the scene that is safe and effective for hot flash relief. Now, I know what you're thinking. We've already got something for hot flashes, bro, that's called estrogen. Been around for a long time. So it has. So it has. But a lot of women don't want to take traditional estrogen for X, Y and Z. Although we've addressed that not too long ago. That really, the black box warning on traditional HRT needs to go away because that's all bad science stuff from a jacked up trial called whi, which let me just say now was groundbreaking. It really got us talking about the game, had us thinking about this, but it was a terrible, terrible study. So this is why we've grown and we've evolved and we've developed. Now we have something like Vioza, which is pretty darn pricey. But if you can afford Vioza, which is not what we're talking about, great. Although you got to check your liver function. So I'm all for something else that comes on the scene. Now what we're talking about is a brand new medication that just got FDA approved on October 24, 2020, 25. And it is not from the same company that has Vioza. This is actually through Bear, it's a separate company. And the non branded name is Ellen Zenitant. The brand name is Linkit. Now I know someone's going to say it different and that's fine. I don't care. L Y N K U E T to me is Linkit. Okay, so Linkit or Ellen Zenithant, which is a close cousin of fesolinitant with some changes. So again, this is great for oral prep review if you're going to get ready to do your oral boards or just if a patient asks you, hey, what's this new thing called Linkit, Because I saw this on the news because it's making its way around the new circuits. And what is this for? Hot flashes? I'm going to tell you, it is kind of like fezolinitant, otherwise known as Vioza, but it's Vioza. Ish. Okay. It's technically not the same. I mean it has different mechanism of action, it is a different structure and we're gonna talk about that. Another question is for women who cannot use traditional medication like estrogen, like women with breast cancer, can this be done for women with breast cancer? There actually is data on that as well that was published in the New England Journal of Medicine and we're gonna talk about that. Last thing we're gonna talk about is, as we talk about menopausal hot flash relief, is that there actually is brand new data on something that's not phezolinosant or elenis. It's a totally different issue. It's a more of a natural estrogen which is actually found in a type of birth control. And we covered this in a previous episode as well. It's actually estradiol. So in other words, not estradiol, not estriol, but tetral, an estrogen compound that's naturally occurring that also has been found to reduce vasomotor symptoms. As it exists in the birth control form that's now seeking approval through this separate study that was done for menopausal symptoms. So Estetrol, that is the new estrogen, it's natural, that has four groups versus estradiol, which has two, Estriol which has three. This is Estetrol and we've covered that in previous episodes. We're just going to touch on that a little bit. Those were called the E4. Get it? E4 estetral, the E4 comfort trials. That's comfort one and comfort two, because that's already been published. Just very quickly, we're just going to touch on that. If somebody asks you about this more natural estrogen called Estetrol, but because that's not the one that's currently FDA approved, we are going to focus on l' Kit or Elinzanatant. That is the brand and the non branded name. So Linket and Elinzanatant, here we go. This is Dr. Chapa's OBGYN no Spin podcast. You know, this is, excuse me, a damn fine cup of coffee I've had. I can't tell you how many cups of coffee in my life. And this, this is one of the best podcast family. We are thankful for our personal partnership with the Strong Coffee company that stands for striving to reach our natural greatness. This is not your regular cup of coffee. This cup coffee with adaptogens to boost mental and physical performance without a caffeine crash. There is a 20% discount for anything that you order through the Strong Coffee company only with the link in our show notes. Again, thank you to the Strong Coffee Company for offering this 20% discount unique to our podcast community with the link in our show notes. So right when we came back, right before we came back, I'm like, michael, where is that? I know we talked about estetrol, the E4, the more naturally occurring estrogen in a birth control. Where is that? So we did cover that. He did find it and we covered Nextellis. So next Stelis. One word. Nextellis. That's the natural occurring estrogen derivative in that birth control pill. And again, that's not our main focus here. But just FYI, that FDA has already approved Estetrol, that's E4.4, as a form of contraception through Nextellis. And now of course using that same compound through the E4, Comfort 1 and Comfort 2 trials is looking for approval for menopausal hot flash relief. And looks good. I mean it's definitely something that can be considered. It's like 15 milligrams or 20 milligrams. Again, that's not our main focus here, but that is recent Data as of October 2025, as well as people look for different ways to give more, potentially safer or more accepted or to rebrand this kind of menopausal hot flash therapy, these vasomotor symptoms to look at them in a new way. So anyway, I just thought that was interesting. E4s Tetriol, and that's the comfort one and comfort two trials. It got better. They got better on the trials with the E4 more natural estrogen. I don't want to focus on that. I've said that enough. I think that's good. We may put that, that reference in our show notes, but I do want to focus on the new medication which was just FDA approved five days from when we're recording this. Right? That's not bad, guys. Got it under the week. I try to do it like within the first one to two days, but I've been a little busy. Been a little busy, you know, patience get in the way, gotta see patients. I got, I got a lot of stuff cooking. I got two manuscripts in peer review, blah blah, blah. All to say is it takes a while anyway, but we got this in within five days. I think that's pretty good. On October 24, 2025, Bayer. It's actually Bayer, but anyway, Bayer did announce that their medication, which is a dual. And here it is, here's a clinical pearl. It's the quote, first and only dual neurokinin therapy. We're going to talk about it, even though we've talked about it in the past when we talked about vioza, we talked about all that science and candy receptors. K, N D, Y. You remember this? Anyone? Anyone? The way that hot flashes work is phenomenal because now we're doing central mechanism. We're doing basically neuromodulation, if you will, of the switches, the little buttons that control the brain that say, make her hot, make her sweat, turn on the heat. And we can do that at the receptor level. These are things related to substance P and neurokinin. It's amazing. All of these things have signaling messengers through the candy neuron system. And that's candy with a K and not C, A, N, D, Y. Well, again, you got to go back, listen to the vioza one for comparison because we talked about this, but this is the kndy kndy kandy as in K N D Y. That stands for the signaling system of kisspeptin neurokinin B and Dynorphin, I.e. k, N, D, Y. Kisspeptin. Neurokinin B, as in boy, dynorphin. Now, the way that these things work is that they are related. However, vioza only hits on one of the channels. So this hits more channels. In other words, hits more switches. And this is an antagonist of Neurokinin 1 and Neurokinin 3. So while Fioza knocks off one switch, this one knocks out two. And you're like, well, is that any better? Is that. Is that significant? The data seems to say so. Okay. The data says yes. Now, before we go any further, I have to clarify this because Michael is putting it in my ear. I get you. Hold on. Sheesh. Just to say. Just to be safe, I gotta say it. And I forgot. Vioza and linkhead, not a sponsor. All right, fine. Geez, man. Give me a minute. I'm trying to talk, and you're talking to me in my ear. It confuses me. Hold on, hold on. Okay, so. So sorry. Are you gonna edit that out? Leave that in there. I don't care. So inhibition of substance P and neurokinin B through the antagonism of Neurokinin 1 and Neurokinin 3. I'm gonna take this thing out of my. If you're gonna keep doing that, I'm gonna take that out. So substance B and neurokinin B through antagonism of neurokinin 1 and neurokinin 3 receptors. So that's the catch here, guys. All right, so let's compare these. Quick. Rapid fire. Rapid fire. That was my rapid fire sound effect. I don't know what has happened. It's the end of the day. I don't know. Anyway, so here we go. So vioza is a selective neurokinin 3 receptor antagonist. Hits one of them. Not bad. That's good. It's real good, and it definitely works. However, Linket or Elinzanatent, is a dual neurokinin receptor antagonist. So these are not agonists. These block the doors. Okay, so these block the doors, which oddly activates the switch. Okay, so you gotta block the door. So the new medication is a neurokinin 1 and 3 blocker, whereas Vioza only hits neurokinin 3. Both of them affect, through these candy neurons, neuroregulatory centers in the brain. Okay, now, there are some mechanism of actions here that are different. Just because you hit that other receptor, you actually get a faster reduction in symptoms compared to vioza. Again, not a sponsor And I'm not trying to pitch a medication to you, I'm just giving you the data that according to the comparison trials, and. And they weren't done head to head. If you take a look at the trial for elinzinitant, it tends to be a little bit faster than Vioza, which takes a little bit longer to give a hot flash relief. Okay. The other big difference is that while vioza or fezzolinitant did reduce hot flashes, it didn't really improve any of the sleep markers for sleep quality. Okay. Actually, some of them said it kind of affected sleep, but. But this new medication seems to affect hot flash reduction just as good as Vioza. With the added advantage is that this tends to improve sleep as well. In other words, it reduces sleep disturbances. So they are similar to each other in that they both work through the candy receptors. However, this new medication takes out two receptors, so it blocks two things, whereas vioza only blocks one. The reason that the FDA approved this was because of the OASIS1 and the OASIS2 trials. These were the two randomized, double blind, phase three studies that included postmenopausal women that were between the ages of 40 and 65. They needed to have moderate to severe vasomotor symptoms. And these were big sites. All right, These are big studies. Both Oasis 1 and Oasis 2 had near 80 different sites. I think Oasis 1 was it Oasis 1, Europe. They both had Europe. Okay, so Oasis 1, here are my sites. Had sites in the US, Europe, Israel, Oasis 2, 77 sites, US, Canada and Europe. So you got a lot of different people, so you have different varieties of sampling, which I love, because it's not just one country. The intervention for these trials were daily. Ellen Zenith at 120mg or a matching placebo, and then see what happens. Okay, and this worked. Now there's also data from the Green Journal back in March of 2025. Now, this is typically the game plan, right? So if you see something that comes out where they're publishing a Phase 3 clinical trial where something worked is because technically that's the trial that was submitted to publication, and that tends to be what is being used for approval. Right? And so look how this works. So this came out in the Green journal, March of 2025, y'. All. And I'm very thankful for, you know, for 10 years I did a clinical trial work and a consultant for a variety of people, both for a device for obstetrics, which is my home, and some gynecology stuff. And that's the game plan that's fine because you've got to call awareness to something. You got to put the data out for peer review to get people to know what it is that makes sense and then it goes up for final approval. So in March of 2025 in the green Journal this was done through a systematic review and meta analysis. Not head to head trials, but looking at fezolinitant and Elinzinitant, this new medication to see if the what is the conglomerate data say for reduction in hot flash symptoms. These were all RCTs that they used and sure enough, lo and behold, they both work. However, however the one, the one winning point here outside of the onset of action that Elinzinitant seems to be a little faster is that quote, according to the green journal, Elinzinet 120mg showed a significant improvement in sleep quality. End quote. So they concluded Elinzinet provided a larger effect size in vasomotor symptom frequency and severity reduction and greatly improved sleep quality compared with fezolinitant. End quote. So there you go. But because nothing is free, while you tended to sleep better and you had quicker hot flash relief to be fair, balanced just FYI because nothing is possible in the sky, nothing, nothing is free guys. Nothing is free. This did come with more headache and some other publications, maybe a little bit of a fatigue. Okay now those are assumed to get better with time, but headache was one of the big issues here. Okay? Headache and fatigue. So we already have fezzolinitant Vioza. This new medication, Elinzinitant or Linkette just got FDA approved, seems to work a little faster, seems to improve sleep quality. However, just like Vioza, this still needs and Bayer still recommends monitoring for liver function tests just like with Vioza. So it's not like you just write the script and you send them on their way. They do need monitoring. Even though this dual molecule seems to be safer and more friendly on the liver, it does require monitoring. Okay now podcast family, as I've told you many times before, we're trying to just say what we need to say and kind of be done. And this is, you know, a pretty quick thing. I'm just doing this as awareness and I hope it is not coming out as some kind of markety thing because no one asked me to do this. Bear didn't pay for this. Vioza definitely didn't pay for this because based on the data, I mean this new medication linked seems to be kind of like Vioza plus, but it is what it is. I need to let you know it's out. And this is out. FDA approved five days ago. Although it may not be commercially available yet in all the markets. And of course, the biggest factor, the biggest factor is the money. Okay. Because I don't know how much it's going to cost, but it's not going to be cheap, I promise you that. So just letting you know what's out there, last thing and then we're going to wrap it up. How about that? We're going to wrap it up. Is is that there is data on linkhead in breast cancer patients. This actually was published in the New England Journal of Medicine. Because these patients, you know, they're very frustrated because you're like, I can't take estrogen, but I'm happy. I'm dying over here with flashes is miserable. My quality of life is horrible. I've gotten the cancer beat that's under check. But this hot flashes are now I'm suffering with this thing. But linked seem to reduce hot flash severity even in these high risk patients. And that is very, very reassuring. So even in breast cancer, this medication, Lynket, because it works centrally, reported significantly fewer hot flashes throughout the day compared to placebo, which you'd figure because placebo is placebo. So, podcast family, I think we've said what we're supposed to say. We've covered the brand new medication for hot flashes just released and approved on October 24, 2025, although it may not be commercially available yet. As always, we're thankful for you. We're glad you're part of our podcast community now that we've done all that. Now, Michael, let's take it home. This has been Dr. Chapa Zobichyn, no Spin podcast podcast family. Thank you for your support. Thank you for listening. And as always, we'll see you on another episode of the no Spin podcast.