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Why are there no long-term humans trials of Noopept?
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Mercy Gina
Why are there no long-term humans trials of Noopept?
I don't see any trials of the drug in the ClinicalTrials.gov database; it seems there is almost no study of this drug clinically besides a couple studies in Russia, let alone long-term human trials. I'm not sure where you get the idea it's used by quite a few people (is this marketing material? how many is "quite a few"?), but it seems to be considered a prodrug of another, piracetam, which is sold in some places for very specific conditions. Efficacy seems decidedly mixed, however.
Drug trials are typically funded by companies who want to manufacture and market the drug for sale. Getting a drug approved for sale can come with huge financial benefits: pharmaceuticals are very expensive. Trials can be very expensive, though, too, and you need your drug to actually be safe and effective to make any money on it. If you can't show that it's safe and effective, your drug fails.
From what I can tell, this drug is primarily sold in supplement form, in an un/underregulated fashion:
Cohen, P. A., Avula, B., Wang, Y. H., Zakharevich, I., & Khan, I. (2021). Five unapproved drugs found in cognitive enhancement supplements. Neurology: Clinical Practice, 11(3), e303-e307.
Crawford, C., Wang, Y. H., Avula, B., Bae, J. Y., Khan, I. A., & Deuster, P. A. (2020). The scoop on brain health dietary supplement products containing huperzine A. Clinical Toxicology, 58(10), 991-996.
If you sell your compound as a supplement, you don't have to show anyone it works, or even that it is safe. You might be able to make some money doing it, but it's unlikely you'll face any consequences. A possible exception is if someone can show you know it's unsafe (even then, it's easy to dodge consequences; see the tobacco industry or Purdue Pharma for examples where producers have been found liable for misleading consumers and yet the actual people responsible remain wealthy).
It seems like no one feels strongly enough that this compound is safe enough and effective enough to put their money up for a long-term trial. You would expect them to start with smaller trials, anyways, and it seems that no one has found it makes financial sense to do that, either. Many otherwise promising drugs are found to fail when exposed to rigorous clinical study.
I don't see any trials of the drug in the ClinicalTrials.gov database; it seems there is almost no study of this drug clinically besides a couple studies in Russia, let alone long-term human trials. I'm not sure where you get the idea it's used by quite a few people (is this marketing material? how many is "quite a few"?), but it seems to be considered a prodrug of another, piracetam, which is sold in some places for very specific conditions. Efficacy seems decidedly mixed, however.
Drug trials are typically funded by companies who want to manufacture and market the drug for sale. Getting a drug approved for sale can come with huge financial benefits: pharmaceuticals are very expensive. Trials can be very expensive, though, too, and you need your drug to actually be safe and effective to make any money on it. If you can't show that it's safe and effective, your drug fails.
From what I can tell, this drug is primarily sold in supplement form, in an un/underregulated fashion:
Cohen, P. A., Avula, B., Wang, Y. H., Zakharevich, I., & Khan, I. (2021). Five unapproved drugs found in cognitive enhancement supplements. Neurology: Clinical Practice, 11(3), e303-e307.
Crawford, C., Wang, Y. H., Avula, B., Bae, J. Y., Khan, I. A., & Deuster, P. A. (2020). The scoop on brain health dietary supplement products containing huperzine A. Clinical Toxicology, 58(10), 991-996.
If you sell your compound as a supplement, you don't have to show anyone it works, or even that it is safe. You might be able to make some money doing it, but it's unlikely you'll face any consequences. A possible exception is if someone can show you know it's unsafe (even then, it's easy to dodge consequences; see the tobacco industry or Purdue Pharma for examples where producers have been found liable for misleading consumers and yet the actual people responsible remain wealthy).
It seems like no one feels strongly enough that this compound is safe enough and effective enough to put their money up for a long-term trial. You would expect them to start with smaller trials, anyways, and it seems that no one has found it makes financial sense to do that, either. Many otherwise promising drugs are found to fail when exposed to rigorous clinical study.
Minor nit: Last December a judge overturned the Purdue Pharma settlement that would have shielded the Sackler family from civil suits. The safety of their wealth is uncertain at this point.More
I agree it's extremely unlikely the Sackler family will come out of this not wealthy. I have no doubt they took steps to shield their assets long ago, so your cynicism is warranted.More
I don't see any trials of the drug in the ClinicalTrials.gov database; it seems there is almost no study of this drug clinically besides a couple studies in Russia, let alone long-term human trials. I'm not sure where you get the idea it's used by quite a few people (is this marketing material? how many is "quite a few"?), but it seems to be considered a prodrug of another, piracetam, which is sold in some places for very specific conditions. Efficacy seems decidedly mixed, however.
Drug trials are typically funded by companies who want to manufacture and market the drug for sale. Getting a drug approved for sale can come with huge financial benefits: pharmaceuticals are very expensive. Trials can be very expensive, though, too, and you need your drug to actually be safe and effective to make any money on it. If you can't show that it's safe and effective, your drug fails.
From what I can tell, this drug is primarily sold in supplement form, in an un/underregulated fashion:
Cohen, P. A., Avula, B., Wang, Y. H., Zakharevich, I., & Khan, I. (2021). Five unapproved drugs found in cognitive enhancement supplements. Neurology: Clinical Practice, 11(3), e303-e307.
Crawford, C., Wang, Y. H., Avula, B., Bae, J. Y., Khan, I. A., & Deuster, P. A. (2020). The scoop on brain health dietary supplement products containing huperzine A. Clinical Toxicology, 58(10), 991-996.
If you sell your compound as a supplement, you don't have to show anyone it works, or even that it is safe. You might be able to make some money doing it, but it's unlikely you'll face any consequences. A possible exception is if someone can show you know it's unsafe (even then, it's easy to dodge consequences; see the tobacco industry or Purdue Pharma for examples where producers have been found liable for misleading consumers and yet the actual people responsible remain wealthy).
It seems like no one feels strongly enough that this compound is safe enough and effective enough to put their money up for a long-term trial. You would expect them to start with smaller trials, anyways, and it seems that no one has found it makes financial sense to do that, either. Many otherwise promising drugs are found to fail when exposed to rigorous clinical study.
I don't see any trials of the drug in the ClinicalTrials.gov database; it seems there is almost no study of this drug clinically besides a couple studies in Russia, let alone long-term human trials. I'm not sure where you get the idea it's used by quite a few people (is this marketing material? how many is "quite a few"?), but it seems to be considered a prodrug of another, piracetam, which is sold in some places for very specific conditions. Efficacy seems decidedly mixed, however.
Drug trials are typically funded by companies who want to manufacture and market the drug for sale. Getting a drug approved for sale can come with huge financial benefits: pharmaceuticals are very expensive. Trials can be very expensive, though, too, and you need your drug to actually be safe and effective to make any money on it. If you can't show that it's safe and effective, your drug fails.
From what I can tell, this drug is primarily sold in supplement form, in an un/underregulated fashion:
Cohen, P. A., Avula, B., Wang, Y. H., Zakharevich, I., & Khan, I. (2021). Five unapproved drugs found in cognitive enhancement supplements. Neurology: Clinical Practice, 11(3), e303-e307.
Crawford, C., Wang, Y. H., Avula, B., Bae, J. Y., Khan, I. A., & Deuster, P. A. (2020). The scoop on brain health dietary supplement products containing huperzine A. Clinical Toxicology, 58(10), 991-996.
If you sell your compound as a supplement, you don't have to show anyone it works, or even that it is safe. You might be able to make some money doing it, but it's unlikely you'll face any consequences. A possible exception is if someone can show you know it's unsafe (even then, it's easy to dodge consequences; see the tobacco industry or Purdue Pharma for examples where producers have been found liable for misleading consumers and yet the actual people responsible remain wealthy).
It seems like no one feels strongly enough that this compound is safe enough and effective enough to put their money up for a long-term trial. You would expect them to start with smaller trials, anyways, and it seems that no one has found it makes financial sense to do that, either. Many otherwise promising drugs are found to fail when exposed to rigorous clinical study.
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