Minerva Awaits Verdict for Schizophrenia Drug from FDA

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Roluperidone for negative symptoms.

''According to Minerva, roluperidone blocks serotonin, sigma and α-adrenergic receptors, all of which play a role in the regulation of anxiety, sleep, cognition and mood. Roluperidone targets a specific subtype of the serotonin receptor called 5-HT2A without directly blocking dopaminergic receptors, allowing it to avoid the typical side effects associated with first- and second-generation antipsychotic medications.

This mechanism of action positions roluperidone as a potential answer to the negative symptoms of schizophrenia, which include lack of motivation and social withdrawal.‘’

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Wow. I didnt know there was research for the negative symptoms

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Tell me about Roluperidone in the style of a standup comedian:

Ladies and gentlemen, gather 'round! :microphone::performing_arts: Let me introduce you to the star of our show tonight: Roluperidone! :star2:

Now, Roluperidone isn’t your average party guest. No, no! It’s not here to tell knock-knock jokes or perform magic tricks. It’s got a more serious gig: treating schizophrenia. :exploding_head:

Picture this: Roluperidone struts into the brain like it owns the joint. It’s got a backstage pass to the 5-HT 2A and σ 2 receptors. Yeah, those are the VIP sections where neurotransmitters hang out, sippin’ on serotonin cocktails. :tropical_drink:

But wait, there’s more! Roluperidone’s got a side hustle—it’s got some affinity for the H 1 receptor too. You know, the one that deals with histamine. So, while it’s battling psychosis, it’s also doing a little dance with drowsiness. :man_dancing::zzz:

Now, let’s talk about its pre-clinical mojo. Roluperidone’s like a backstage magician, pulling out the Brain-Derived Neurotrophic Factor (“BDNF”) from its hat. BDNF’s the rockstar associated with neurogenesis, neuroplasticity, and memory. :brain::star2:

But here’s the plot twist: Roluperidone had its moment in the spotlight during phase III clinical trials. The crowd held its breath, waiting for the grand finale. And… drumroll, please! :drum:

Plot twist #2: The trial didn’t quite hit the high notes. It missed the primary endpoint of reducing negative symptoms. The audience gasped! :scream_cat:

But hold your applause! In a surprise comeback, Roluperidone submitted a New Drug Application (NDA) to the FDA. It’s like the Rocky Balboa of antipsychotics—down but not out! :boxing_glove:

And guess what? The FDA sent a refusal-to-file letter. Ouch! But Roluperidone’s not giving up. It’s got that gritty determination, like a standup comic facing a tough crowd. “I’ll be back!” it says. :studio_microphone:

So, folks, keep an eye on Roluperidone. It’s the underdog, the dark horse, the wildcard. And who knows? Maybe one day, it’ll steal the show and have us all laughing at life’s crazy twists and turns. :crazy_face::clap:

Remember, don’t mix it with alcohol—unless you want your brain doing the Macarena! :man_dancing::beers: And that’s the Roluperidone saga, my friends. Stay tuned for the next episode of “Antipsychotics Unplugged”! :notes::tv:.

Source: Conversation with Bing, 21/02/2024
(1) Roluperidone - Wikipedia. Roluperidone - Wikipedia.
(2) Efficacy and Safety of Roluperidone for the Treatment of Negative … Efficacy and Safety of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia | Schizophrenia Bulletin | Oxford Academic.
(3) Roluperidone (MIN-101) • Minerva Neurosciences. Roluperidone (MIN-101) • Minerva Neurosciences.
(4) en.wikipedia.org. Roluperidone - Wikipedia.

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As always, if its use is finally permitted, one will have to wait a year or ten for the marketing hype to fade and for side-effects to become known. But still it’s better to have more drugs than fewer.

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So, if it plays a role in cognition, it may help cognition, too?

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The medication should positively impact cognition as well. It depends on the concept you have of negative symptoms and cognitive symptoms.

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I asked A.I.

did Roluperidone miss it’s primary end point in phase 3 trials

And it said

Roluperidone, a drug being investigated for the treatment of negative symptoms in schizophrenia, unfortunately failed to meet its primary endpoints in a Phase III clinical trial². The study included 513 patients with schizophrenia who were administered either 32 mg/day or 64 mg/day of roluperidone, or a placebo for 12 weeks³⁴. Despite the setback, research in this field continues, and scientists remain committed to finding effective treatments for this challenging condition.

Source: Conversation with Bing, 22/02/2024
(1) Minerva Neurosciences’ roluperidone fails in Phase III study. https://www.clinicaltrialsarena.com/news/roluperidone-schizophrenia-data/.
(2) Minerva Neurosciences Announces Publication of Roluperidone Phase 3 … https://ir.minervaneurosciences.com/news-releases/news-release-details/minerva-neurosciences-announces-publication-roluperidone-phase-3.
(3) Minerva Neurosciences Announces Publication of Roluperidone - GlobeNewswire. Minerva Neurosciences Announces Publication of Roluperidone.
(4) ROLUPERIDONE: Topline results from the Phase 3 trial: A Multicenter … https://ir.minervaneurosciences.com/static-files/c4ab2610-9da5-4024-b29c-1353136f5192.

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Yes, the medication had failed in previous tests. But I think that now they added more tests and did more medical trials. Hopefully it will be approved.

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I don’t have a clue what’s going on with it to be honest…

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If I remember correctly phase three was conducted during the pandemic and there was an unusually high response to the placebo. I remember a couple of years ago there was a guy on Reddit posting about it. Not sure how he got the drug but he said he definitely had a little more get up and go on it. Same thing with Rl-007. A guy on Reddit was a part of the trial for it and said he’d never been more productive in his life on it so if roluperidone gets denied there’s still that to hope for.

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