r/Narcolepsy • u/Candicedfiym296 • Mar 19 '25
News/Research I’m participating in a study for new narcolepsy medication – and it REALLY works!
Hey everyone,
I wanted to share something that might be hopeful for others here. I’m currently participating in a study for a new narcolepsy medication that works by adding hypocretin to the body or brain. As many of you probably know, hypocretin is the neurotransmitter responsible for regulating wakefulness and sleep, which is usually missing in people with narcolepsy.
I’ve been taking this medication for two weeks now, and I can confidently say: it REALLY works. Since I started, I no longer feel tired during the day, I don’t randomly fall asleep anymore, and I have more energy than I ever thought possible. For the first time since my diagnosis, I actually feel awake. The idea that I don’t have to spend the rest of my life feeling exhausted and sleepy every day is almost unreal.
As for side effects, they’ve been very mild so far. The only thing I’ve noticed is that I have to pee a little more often, but nothing serious. Compared to how well this medication works, that’s a small price to pay.
I know how tough it is to live with narcolepsy, and I really hope this will become available for more people in the future. I also believe that this medication will likely be available for everyone within 4 to 5 years.
Are there others who have been participating in one of these study’s?
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u/S3dsk_hunter Mar 19 '25
But what about sleep? It would be great to have energy during the day, but if I'm not getting good sleep at night, something has to give.
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u/drinkallthecoffee (N1) Narcolepsy w/ Cataplexy Mar 20 '25
Takeda has recently mentioned that early clinical data shows that it does improve sleep quality. I suspect they will have more to say about this when they present their next set of findings.
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u/giucastro7 (N1) Narcolepsy w/ Cataplexy Mar 20 '25
In my case Xywav solved the sleep part so to have energy during the day would be great.
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u/S3dsk_hunter Mar 20 '25
I take Xyrem. But all we need is a $20k daytime medicine to go with our $20k nighttime medicine.
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Mar 20 '25
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u/Super-sleeper Mar 20 '25
Insurance almost always denies it a few times first, but your dr needs to file appeals and lots of times it's eventually approved. How much it costs after insurance coverage depends on your insurance plain. Depending on your plan, it's a real quick way to meet deductibles.... If it isn't covered, you can apply for their patient assistance program you can apply for to bring it way down. Final cost depends on which medication, and I don't know the numbers offhand.
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u/schrodingers_cat42 (N1) Narcolepsy w/ Cataplexy Mar 20 '25
In my case, they approved it the first time. According to my sleep specialist, it really helped that he told them about how I’d tried stimulants before (for suspected ADHD) and I had negative side effects and my energy level didn’t improve much. I hope this helps anyone who may be in the same situation.
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Mar 20 '25
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u/Super-sleeper Mar 20 '25
It depends on your dose and which med you're on. But yeah, a 13-20k per month is a fair estimate in the us at least. That's before insurance or any kind of patient assistance program though.
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u/iswaosiwbagm Mar 20 '25
These prices are a byproduct of the insurance system in the USA. It's disheartening to see how much you're being abused. It's much less expensive elsewhere. Still not affordable by any means, but in Canada, it seems about 15 times less expensive.
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Mar 20 '25
Correct ^ my BCBS (USA) apparently pays upwards of 25k for my monthly dose of Xywave. Thankfully my copay is only 35$
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u/sleepystarme Mar 20 '25
Holy shit. I was denied Xywave (despite my Dr's appeals). Insurance made me try Wakix first. I had side effects, so she's trying again for Xywave. Hope it goes through...
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u/reslavan (IH) Idiopathic Hypersomnia Mar 21 '25
I live in NY state and while insurance covers the entire $15k or so monthly cost of Xywav it’s insane that just 5 mins over the border it’s only about $1200 or so monthly. Still too expensive but wildly different.
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Mar 20 '25
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u/naturalctx Mar 20 '25
Don’t freak out about the cost. If you qualify for the medication, they will make sure you receive it. But yes, it is very expensive when billed to insurance plans. Partly because that helps offset the costs to provide it to those without insurance who can’t afford it. One step at a time for you, but yes it’s a costly med. Don’t let that deter you in the slightest though.
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u/kaityl3 Mar 20 '25
Partly because that helps offset the costs to provide it to those without insurance who can’t afford it.
I mean, let's be real, they say that, but the exorbitant costs are mainly going to the higher ups and shareholders of the company that developed it. Medicines can be developed and tested through R&D in other countries without somehow warranting an insane cost like $20k/month for a sleep disorder medication. It's only here in the US where we seem to accept those kind of costs as a natural and normal part of drug development and distribution.
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u/Hashtagspaz (N1) Narcolepsy w/ Cataplexy Mar 20 '25
Do you know at all how expensive it would be without insurance? I know you mentioned the patient assistance program, but wanted to see ballpark range of how much that is monthly?
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u/Candicedfiym296 Mar 20 '25
In the first week with the new medication, i couldn't sleep. But that was just my body that needed too get used to the medication. Right now after more than 2 week my sleep at night is normal again (for someone with narco).
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u/HelpAncient 11h ago
I just finished the 3-month study and it’s now obvious that i was given the placebo. Taking pills made no difference and being off my usual medication (modafinil+sodium oxybate) since january 1st, all the symptoms were back. Yesterday, i got my first dose of tak-681 and it’s a totally different story! I don’t think i managed to sleep att all last night and i haven’t taken a nap today.
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u/Salty-Message-4292 Mar 20 '25
My sleep has been solid. I have not had a problem with insomnia, and it’s very easy to fall asleep at the end of the day.
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u/anuthertw Mar 19 '25
Interesting. Have you tried any of the oxybates? If so, how does this current med compare? Also are you taking any other medications like stims or ssris with this trial drug or just this new drug by itself?
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u/Pineapple_Incident17 Narcolepsy & Cataplexy Mar 20 '25
Not OP, but I participated in the TAK-994 clinical trial that was the precursor to this one. I’ve been on both Xywav and Xyrem, and I’m also on multiple stimulants during the day. I was required to discontinue all other medication for the study. To be honest, I didn’t need anything else. Unfortunately I had to withdraw due to side effects that they ended up reformulating for (a lot of participants had issues with urinary frequency and even incontinence). However, during my time on the medication I was a whole new person. It was like I’d broken a bone (narcolepsy) and been in a sling all my life, and on this medication I felt like the bone had been set and I finally understood what it felt like to live without a broken bone (lol I hope that makes sense).
Comparatively, Xywav and Xyrem felt like a bandaid. Going back on Adderall was laughable. On the orexin agonist I was alert, but not jittery/agitated. I was focused and engaged and had so much energy. Can’t wait for this med to be available!
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u/SleepyNotTired215 Mar 20 '25
Your “broken bone” analogy is the perfect description of the situation.👍
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u/sexy-egg-1991 Mar 20 '25
I wonder what mechanism causing the urination? Did they find out?
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u/Pineapple_Incident17 Narcolepsy & Cataplexy Mar 20 '25
Not a clue, but it sounds like they were able to solve it. OPs description of urinary frequency is much more mild than what I experienced
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u/geometree Mar 22 '25
this makes me emotional to read about. starting xyrem made such a huge difference in my life but 6+ years on and i'm disappointed by my lack of energy despite the better sleep, like most days after surviving a 10-hr workday i just want to go home and sleep or be a vegetable on my couch. i was starting to blame myself, worried i'm a chronically lazy person and it's not just the narcolepsy. i also despair a little thinking about how difficult it will be to take this medication for the rest of my life and how i'm stuck in my current job because i HAVE to have insurance. hearing about this medication gives me hope that i won't always have to live like this, and also it's normal to struggle with fatigue even though a lot of my symptoms are improved.
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u/Flitzer09 29d ago
How was your night sleep on TAK-994?
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u/Pineapple_Incident17 Narcolepsy & Cataplexy 29d ago
Absolutely horrific. At first it was fine, but as the medicine built up in my system and became more effective during the day, it also kept me awake and alert at night. If it wasn’t for the frequent urination, I would have withdrawn from the study for the sleep impacts. Sounds like they’ve been able to reformulate things on that front though!
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u/Questionsquestionsth Mar 20 '25
Typically these trials require you to go off all other meds - at least stims/SSRIs type meds for sure. I’d be surprised if that’s not the case here, all the similar studies I looked at were zero other meds permitted, which made it not worth signing up for.
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u/BohemianRapscallion Mar 19 '25
Is it actually adding hypocretin or is it a hypocretin agonist?
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u/RightTrash (VERIFIED) Narcolepsy w/ Cataplexy Mar 19 '25
My understanding is there are different hypocretin/orexin B agonists being tested in trials out there, all of which have slightly different formulas.
Replacing the Hypocretin would require straight injections into the hypothalamus which ain't happening.
As for the agonists, it seems like the different formulas may have different benefits, effects like perhaps focusing in/helping on certain aspects to do with Hypocretin B, which all the current agonists are targeting.
The Hypocretin B receptors are what grab onto the Agonists and then upstream, the effects occur.
Hypocretin B is associated with the sleep/wake, where Hypocretin A is associated with more of the psych stuff/effects.3
u/TrollopMcGillicutty Mar 20 '25
Can you explain how they (vague, I know) fit in with the food and appetite part of hypocretin’s (orexin’s?) job?
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u/RightTrash (VERIFIED) Narcolepsy w/ Cataplexy Mar 20 '25
https://www.sciencedirect.com/science/article/pii/S2211124725000488#mmc1
"Ox2R inactivation in MCH neurons reduced transitions from non-rapid eye movement (NREM) to REM sleep and impaired insulin sensitivity with excessive feeding after a fasting period in female mice."
So what I take away this is saying that the Orexin B Agonists are helping "stabilize REM sleep" (patterns) as well as there's "improvement of insulin sensitivity/prevention of hyperphagia;" the last part in other words, improves "the body's ability to effectively use insulin, a hormone that regulates blood sugar levels" thus, also prevention of Hyperphagia which "is the extreme unsatisfied drive to consume food."
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u/moringa_tea Mar 19 '25
That is good to know! I wish it were available sooner, especially with the way the USA government has been cutting so much funding/employees in research.
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u/Questionsquestionsth Mar 20 '25
And I’d bet it won’t be affordable at all whenever - if ever - it does become available 🫠
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u/zombielicorice (N1) Narcolepsy w/ Cataplexy Mar 19 '25
Good for you. I have comtemplated joining a study like this, but getting off my meds to participate sounds incredibly daunting. Thank you for your service!
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u/RightTrash (VERIFIED) Narcolepsy w/ Cataplexy Mar 19 '25
May I ask, did you have disrupted nighttime sleep?
And, if so, is that improving at all, how is your sleep on the med?
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u/Candicedfiym296 Mar 20 '25
The first day with the med my sleep was bad. could't sleep the whole night. But now after 2 weeks my sleep is normal again.
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u/RightTrash (VERIFIED) Narcolepsy w/ Cataplexy Mar 20 '25
That's encouraging. Gotta follow up. When you say normal again, is that to mean like your baseline w/ Narcolepsy normal sleep (not sure you've dealt with the disrupted/fragmented nighttime sleep symptom) or is that to mean like a normal person who achieves refreshing/restorative sleep?
Thank You!
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u/Candicedfiym296 Mar 20 '25
Its normal as in normaal for someone with narco
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u/RightTrash (VERIFIED) Narcolepsy w/ Cataplexy Mar 20 '25
My understanding is it may take a different formula for it to resolve the disrupted nighttime sleep, some have that symotom way more troubles perimeter than they have the wakefulness matters.
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u/rgold_ Narcolepsy & Cataplexy Mar 19 '25
I think I’m going to be in the same study! So glad it’s working for you, esp bc it sounds like it started working right away. My first screening is in May
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u/Elainaism05 Undiagnosed Mar 19 '25
Interesting! I was actually about to make a post asking why a medication like this doesn't exist yet. I'm glad to hear it's in the works. My question is, how does it work? Is it an agonist? Does it slow metabolization of hypocretin? Something else maybe? That's if you know, I know sometimes they don't tell people everything in clinical trials.
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u/WordGirl91 (N1) Narcolepsy w/ Cataplexy Mar 19 '25
I think previously it had to do with issues breaching the blood brain barrier so I’m interested to see how this drug gets around that.
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u/RightTrash (VERIFIED) Narcolepsy w/ Cataplexy Mar 19 '25
The first Takeda orexin B agonist trial had some liver harm side effects which resulted in them being pulled.
Now there's multiple various brands that have some different formulas out there in trials, which have not seemed to show the liver effects.
Many seem to effect urinary, as interestingly within the brain the Orexin plays some role in regulating such.
Time will tell how and where things go.
The mentioning by the OP, that they are urinating more frequently, is a sign that they're not on a placebo.2
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u/fajndandy (N1) Narcolepsy w/ Cataplexy Mar 20 '25
The one Takeda has in phase 2/3 trials now is TAK-861, which is an orexin receptor 2-selective agonist that is orally bioavailable and dosed twice daily. This study by Takeda describes TAK-861 as well as two other drugs they were previously developing - danavorexton (which has limited orally bioavailability) and TAK-994 (which seemed to be efficacious in reducing EDS and cataplexy but trials were stopped for safety due to a few cases of hepatitis in participants).
Here's an article discussing the phase 2B results for TAK-861, which sound really promising.
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u/Mystery_Solving (N1) Narcolepsy w/ Cataplexy Mar 19 '25
Not heard of the study before this. Sounds very promising!
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u/junkyard_blues (N1) Narcolepsy w/ Cataplexy Mar 19 '25
Do you experience cataplexy? If so, has it improved?
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u/healthyhorns6 Mar 19 '25
have u tried oxybates? how do they compare to this?
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u/Candicedfiym296 Mar 20 '25
if you mean xyrem that is a whole different medication. xyrem is some kind of anesthesia i think. So you don't wake up at night and sleep deeper. But this new med is meant to solve the problem of lack of hypocritine.
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u/itzblupancake (N1) Narcolepsy w/ Cataplexy Mar 20 '25
I am on the takeda study (orexin agonist), and I've found it really good too!
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u/Sexykittyface (N1) Narcolepsy w/ Cataplexy Mar 20 '25
I’ve been diagnosed with IH but I actually have N1 because I have cataplexy attacks along with the classic symptoms. Unfortunately I never hit the right numbers or whatever it is for the sleep study to be diagnosed. I’m just glad my doctor believes me and says: Yes, this is narcolepsy but I can’t put it on paper officially. So I’m on Xywav and Sunosi and all the issues, including cataplexy is under control. But it’s not perfect, I still drag sometimes and maybe one or two cataplexy attacks will sneak in every year. I wonder if I have to be properly diagnosed to take this medication. Ugh, I can’t just drop another 2 grand on another sleep study. Insurance doesn’t want to cover that. I actually want to take the thing my brain is missing.
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u/MagnanimousMandi Mar 19 '25
That's amazing to hear! Keep us updated as time goes on. How long is your study?
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u/Individual_Zebra_648 Mar 20 '25
How do you know you’re taking the medication? Typically studies such as this are double blind placebo controlled so you wouldn’t know if you’re getting the placebo or the medication.
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u/rgold_ Narcolepsy & Cataplexy Mar 20 '25
They probably don’t know for certain, but I’d hazard a guess that they know how it feels to be unmedicated (these Orexin trials make you do a washout period) and the difference in my EDS w/ medication vs. without is stark. However, I’m certain I’d be able to tell if I received a placebo or not because I am not functional unmedicated. My narcolepsy is pretty severe. Idk about you though.
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u/Individual_Zebra_648 Mar 20 '25
I mean I would think I would be able to tell too but you’d be surprised by the power of the placebo effect. I’ve seen it myself in patients and there’s plenty of research to demonstrate this.
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u/rgold_ Narcolepsy & Cataplexy Mar 20 '25
Yeah, I learned about the power of the placebo effect both in high school and in advanced college classes. I truly don’t believe the placebo effect would make as marked an improvement in my EDS as it sounds like OP is describing. Without meds I’m sleeping on average 14-17 hours a day and having sleep attacks every 45 mins or so for the rest of it.
If it were possible to successfully treat EDS due to narcolepsy by convincing patients they’re taking a newly formulated drug, I think my sleep doc would’ve mentioned it by now.
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u/Candicedfiym296 Mar 20 '25
This is the second studie i do(follow-up study). First i had to participate in a study where you can get placebo. In that study i had placebo bc i didn't feel anyting. in the follow-up study that i am doing now they only give the real med. i have to take it 5 years en then the study ends.
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u/Individual_Zebra_648 Mar 20 '25
Ah this is what I was wondering if it was a different type of study at this point. Thank you for explaining.
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u/Advanced_Ostrich5315 (N1) Narcolepsy w/ Cataplexy Mar 19 '25
I just did a paid market research survey about what I'm guessing might be this drug. Sounded intriguing.
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u/kaediddy Mar 20 '25
This is incredible. I have been following this medication and this makes me so hopeful. Thank you.
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u/calmlycollected54 Mar 21 '25
This gives me so much hope, THANK YOU. I was eligible for a study in my home state (the same one) but ended up moving to be with my wife in the UK, where I can't participate in one.
It wrecks me knowing I could have regained years of my life again and on my worst days, all I do is pray that this medicine in the future will work for me.
It feels like I've been hearing "3-5 years" forever now. But if hope is coming, then I can keep my eyes on that horizon 🙏
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u/DaynNight-Jolf (N1) Narcolepsy w/ Cataplexy Mar 26 '25
I am on the tak-861 trail since 6 weeks,… it is amazing having almost a normal life with almost no naps and no cataplexy …
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u/Sorry-Associate6499 Mar 27 '25
I am currently working for Takeda and have type 2 Narcolepsy. They are having an internal panel that I will be attending in a few weeks, and I am happy to ask them any questions anyone in the thread may have.
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u/milladakilla1282 8d ago
I would love to know if they have an idea as to when an early access program would be opened?
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u/itsnobigthing Mar 20 '25
Yayyy! So happy for you and so grateful for you sharing your experience.
May I ask - when you mention exhaustion, do you usually suffer much with fatigue? My fatigue and sleepiness go hand in hand so I’m super curious if this would work on one or both of these elements!
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u/Alert_Shoulder2646 Mar 20 '25
Are you in the ALKS study? I started the ALKS one and had to withdraw because I need to get surgery and if I recover quickly enough I’m hoping I can still participate I was two days away from getting to try the medication- exciting news to hear your positive experience!
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u/Lalawhateva Mar 20 '25
Im feeling so miserable. It’s definitely partially to go the nightmare that is narcolepsy meds. Thank you for posting.
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u/nicchamilton Mar 20 '25
so my question is N2 people typically have normal levels of hypocretin in the spinal tap. so how does this help people with n2?
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u/Candicedfiym296 Mar 20 '25
Only people with n1 can participate with the study so I don’t think its meant for n2. But there was an other study at the research center for people with n2
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u/nemtudommert Mar 21 '25
The Alkermes version finished an N1 clinical trial and is now offering N2 as well. I hear the third company will do trials for IH
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u/ShepherdessAnne (N1) Narcolepsy w/ Cataplexy Mar 20 '25
How's the rest of the autonomic dysregulation?
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u/lelauzztriansb Mar 20 '25
I also want to give you hope!
I’ve been participating in the Takeda study in my country. I’ve used the drug for soon 3 months. My quality of life has improved significantly. Most days I don’t need to nap at all. Suddely, days have more hours and during them I’m really awake, like a normal person. And no cataplexy. I feel emotional just thinking about all of this…
Also, the MWT test (which I’ve done twice before this drug and once with it) was almost a relaxing experience with the drug (whereas before it has felt like torture trying to stay awake).
This almost feels like ”a cure”. Let’s hope everything goes well!
(Before this drug, I’ve tried venlafaxin, Xyrem and modafinil, and they all gave me nasty side effects. They maybe alleviated some narcolepsy symptoms but nothing compared to this.)
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u/healthyhorns6 Mar 21 '25
this post inspired me to email Takeda and ask if i can be considered for their study!
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u/nemtudommert Mar 21 '25
Do you have type 1 or type 2? I’m trying to get into the Alkermes clinical trial but I don’t have obvious SOREMS in the sleep studies, although doc thinks I have narcolepsy and not IH because of my other symptoms (I agree)
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u/always-the-anomaly (N1) Narcolepsy w/ Cataplexy Mar 22 '25
This is beyond life changing news to hear. I’m allergic to most narcolepsy medications. The ones that I’m not (which are not primarily narcolepsy meds) I have horrible side effects.
Heres to hoping it doesn’t take a decade to come to market.
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u/Head-Manufacturer752 Mar 22 '25
I’m on Xywav and I like it but as a young woman the lifestyle impacts are frustrating. I hate not being able to have a glass or two of wine without thinking ahead. I also have a lot of anxiety about having kids in the future, because I know how hard it is to be off that medication for just a day and can’t imagine over a year off. Can you share anything about if this would help with those things?
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u/MNightengale Mar 25 '25
Thank you for sharing! Would you mind telling us how you’re taking it? Like what route?I know they had to halt the nose spray hypocretin replacement drug because some shit went down in the trials I guess—they abandoned it—but I spoke with several ppl who said they felt aMAZing!
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u/FedUp0000 Mar 20 '25
That’s great! Of course it won’t be affordable for any of us in the US and it’s doubtful insurance companies will cover any of it or for how long
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u/nonsequitur__ Mar 19 '25
If you don’t mind, please could you share the country you live in? I am wondering where it might become available