A human trial of oral BPC-157 was quickly canceled

[sammmy]

Phase I, pilot study in healthy volunteers, to assess the safety and pharmacokinetics of PCO-02, which active ingredient is BPC-157, a pentadecapeptide from gastric source.

Conducted in 2015.

Canceled in 2016 with NO EXPLANATION - either not effective or dangerous.

CTG Labs - NCBI

clinicaltrials.gov

 

[Deleted member 43589]

Interesting that it was cancelled but I would be hesitant to jump to any conclusions. I just sent an email to Rufino Menchaca, PhD who was the head of this study in Mexico. Hopefully he can clue us in.

 

[sammmy]

The fact that they did not publish any result and did nothing for 8 years after the trial in 2015 means that the drug company thinks the drug is not marketable or has safety concerns. This is the usual history of failing drugs.

 

[testiculus]

No it doesn't. So according to your standard then Metformin isn't safe or effective. Trials get cancelled for lots of reasons. Usually for a lack of funding. Remember BPC-157 can't be patented, so no pharma company is going to pursue doing any research with it.

 

[sammmy]

No it doesn't. So according to your standard then Metformin isn't safe or effective. Trials get cancelled for lots of reasons. Usually for a lack of funding. Remember BPC-157 can't be patented, so no pharma company is going to pursue doing any research with it.

BPC-157 and its drug delivery variations have quite a few patents already.

If there was a "lack of funding" then they wouldn't start a Phase 1 trial and complete it, which is extremely cheap in Mexico. Since the trial was completed and the results not published, the only logical conclusion is that they didn't like the results.

 

[Guided_by_Voices]

BPC-157 and its drug delivery variations have quite a few patents already.

If there was a "lack of funding" then they wouldn't start a Phase 1 trial and complete it, which is extremely cheap in Mexico. Since the trial was completed and the results not published, the only logical conclusion is that they didn't like the results.

Even if "they didn't like the results", that has no actionable meaning for this demographic and the ways we could be using it. Most here are using injectable or topical, combining with other therapies, and evaluating different doses, just to name three variables. Drug trials are often done with "hard cases" who expect the drug alone to perform miracles.

 

[Nelson Vergel]

I bet they found the oral version not to absorb well. We know that.


Intervention description:The study consists of the oral administration of PCO-02 tablets, each containing 1mg of BPC-157 or placebo. There will be two different administration schemes, which have been labeled as Phase 1a and Phase 1b.

Phase 1a: Single dose administration of 1, 3 or 6 tablets of PCO-02 or placebo.
Phase 1b: Oral administration of 3 tablets of PCO-02 or placebo three times daily for 2 weeks.
Study Goals:General: To assess, in healthy volunteers, the safety and pharmacokinetics of the oral administration of PCO-02, which pharmacological active product is BPC-157.

Primary: To assess the safety of the oral administration of BPC-157.
Secondary: To document the pharmacokinetics of BPC-157 after oral administration.
Study Design: This is a phase-I, randomized, placebo controlled, pilot study, in which a group of 42 healthy volunteers will receive orally an active compound (PCO-02) or placebo (PCO-03) to assess safety and pharmacokinetics.

 

[Deleted member 43589]

PCO-02 is actually Bepecin (BPC 157/PL 14736), I have not heard from Dr. Menchaca, which is not uncommon during the holidays. But I suspect Nelson is right, the oral tablets of Bepecin did not absorb very well, especially at such a low dose. There is no doubt in my mind that this synthetic gastric substance is completely safe and effective. It works well as I have used it successfully many times and WADA has made an extra effort to keep it out of sport.

 

[sammmy]

They did not need it to absorb. It was a pre-trial for for BPC-157 in Ulcerative colitis, which requires topical action, not absorption. Yet nothing published in 8 years except some poster in Digestive Disease Week 2023 that few can access:

Bepecin - PharmaCotherapia - AdisInsight

PharmaCotherapia is developing bepecin (BPC 157, PL 14736), a small, chemically synthesised pentadecapeptide, which is a fragment of a protein initially

adisinsight.springer.com

 

[sammmy]

A Phase II study for BPC-157 in the form of enemas for Inflammatory Bowel Disease was started in 2002 and again radio silence after that, no results published, no phase III study initiated, which means they did not like the result or have safety concerns:

The development of PL 14736 for treatment of inflammatory bowel disease

CroRIS

www.croris.hr

This is rather sketchy and doesn't inspire confidence in the main claim behind BPC-157 that it is protective in the gastro intestinal tract. You don't prove a drug safety and effectiveness by just doing trials and not publishing anything after that. It does sound fancy to the "labrats" that it is in trial, but not after 20 years have passed and there are no results. You don't find an effective drug for IBD or Colitis and sit on it for 2 decades ...

 

[Deleted member 43589]

The only sense I can make out of this is I know athletes in several sports and at the top levels who have used this stuff to heal up injuries very quickly. If it didn't work, the novelty of this would have worn out long ago. I also see now that it is being marketed to race horse owners and trainers. These guys spend over $100K for a horse and use only the best. Go out to your closest horse track and see how the horses are treated.

Again, maybe 7 years ago, I tore the right pectoralis attachment at the bicep doing heavy dumbbells. I heard it tear, dropped the weight and had a good bit of bruising within a few minutes. It was easy a grade 2 injury. When there is bruising, the muscle has been torn to some degree. This is typically a 2-3 month rehab. I used BPC 157 ~600mcg/d, w/micro-dosing and the bruising was gone in a few days, the pain and swelling gone in 2 days. The next week I did very light weight for 40 reps and the week after I went right back to the heavy weight. I felt 100%. Had it taken me 2-3 months to rehab, I would have never wasted another dime on this stuff.

Now I also recently use it on osteoarthritis. Worthless. I got some pain relief for a few hours but no improvement in the condition of the bone or cartilage at all and have x-raw evidence.

Does it work for everyone? I have no idea but I am do not know anyone in my circles that has used it and said it was 1) worthless or 2) dangerous.

Now as to why this study ended? My guess is they ran out of funding. Getting past stage 1 gets very expensive. Most likely why BPC has not been investigated very much as well. Everyone and their dog sells the stuff already all over the internet and it is produced by the tons in China as a pentapeptide is very easy/cheap to synthesize. Going to be very expensive to get a patent and make your money back from an investment. Other than my guess, there is absolutely no evidence to suggest why this trial was ended until one of the people involved make it public. I am trying to remember but it seems BPC 157 1st hit the market in 2012 after the Chinese started selling it in quantities. Since then I am sure thousands have used this product.

I have always been on the cutting edge of being willing to try new techniques for getting bigger and stronger and had no problem doing this peptide when it came out. I remember when injectable creatine came out in the early 1990-91. I jumped right on this one as well despite all the naysayers who told us we just don't know the long term effects. No regrets here either.

 

[sammmy]

The point of this thread is that there are no human studies proving safety and effectiveness of BPC-157 and all the human "research" that is proudly stated on sites selling peptides consists of canceled and unpublished "trials".

The lack of funding argument does not apply, because there aren't even case study reports, which require minimal funding.

User anecdotal reports do not prove safety - if someone got cancer years or decades later, they won't connect it to BPC-157 usage. There aren't even studies in mice with tumors to see if it promotes metastases, so nothing was done to address this concern.

User anecdotal reports do not prove effectiveness either because in your case you don't know what your natural course of healing would have been without BPC-157. There are also negative reports on this site. A drug is not validated by the popular opinion about it that it is "safe and effective". That's what studies are for.

This peptide of 15 amino acids is actually synthesized by Genetically Modified bacteria and I am not convinced that is easy to do. Considering how inconsistent and contradictory the low quality "research" is on this, I am starting to doubt it is actually part of "human gastric juice" because that has not been confirmed independently outside Croatia. If it is not "all natural", then the whole idea that it is safe goes out of the window.

 

[Deleted member 43589]

Holy shit this is going to be a long one........this makes me remember all the mRNA vaccines that never completed stage III or IV showing long term effects. Yet millions of people all over the world took the chance and got the jab.

This peptide hit the markets in the first place because athletes saw that it might work well for injuries. It was sold underground since about 2012 and those who gave it try were amazed at how well it worked. This is not popular opinion but educated observation by people that know their bodies well. Most of these same people have been using it frequently for almost 12 years which is longer than a stage IV clinical study and no one has ever been shown to have had serious side effects. Its not until the masses joined in that minor side effects started happening. But then we also get the same when people take testosterone and can't sleep.

Here is the problem which attributes to people making the decision to try a substance that has not been approved by the mighty FDA (which did approve nRNA vaccines without completing a clinical trial):

In the USA, figures from 2008 show that 33 million musculoskeletal injuries are reported per year, with 50% involving ligament and tendon injuries (James et al. 2008). Figures also show that an estimated 300,000 tendon and ligament repair surgeries are performed annually in the US alone (Pennisi 2002). Prevalence of injury is also mirrored in professional sporting populations, with the diagnostic grouping of ‘most common injury’ as skeletal muscle/tendon in nature, accounting for 45% of all diagnosed injuries (Brooks 2005). Thus, the need for a therapy that can alleviate the social and economic burden that presents itself with debilitating and recurring soft tissue injuries is apparent.​

​

We live in a medical society where surgery is the answer for everything. You can't get doctors to think outside the box because there is more money to be made with surgery. Active people are looking for other options and are willing to try what our medical society and the FDA ignore. 1000's of high level athletes found BPC 157 over the past 12 years or so to be very beneficial, keep them out of surgery and return to sport quickly.

This same thing happened back in the 60's when pharmaceutical companies and the medical community told athletes that anabolic steroids would not help grow muscle, would not increase athletic ability or speed up the healing injuries. I remember the inserts on the boxes that came with injectables. Despite these warnings we all tried them and were amazed at how well they worked. Yea, we actually got stronger and did much better in sport. No clinical trials were needed, proof so to say was in the pudding. Long term effects? NO ONE cared. Your dreams in competition and winning are all that matter. Kind of hard for those who never competed to understand how and athletes mind works but winning is the only goal. What ever might give you and edge will be used. Now look at the millions who jumped on board to use testosterone.

When GHRPs and GHRF's came out there was a group of us who read what ever research there was available, put 2 and 2 together and found Chinese lab 2who were willing to export this back in 2005. We gave them a try, did blood testing and posted our results to forums on the internet keeping very detailed records of doses and results. Look at the sales now. But how much of this has ever been approved by the FDA? But we took the chance. Now look what happened to the market regardless of clinical trials or FDA approval. Again, many times what happens in the trenches is much more important that what the FDA approves. Many times FDA approval has little to do with safety or that the product is remotely effective. It seems to be about how much money and power a company has to push their product through.

In 12 years of using BPC 157, I have had no rashes, not sleeplessness, now hives or any other side effects you read about on Reddit. Most likely any side effects that are real come from the source where the BPC 157 is made or the water being use to reconstitute. there are some allergic reaction duet to the additives in the synthesis process.

Now why would anyone invest in taking BPC 157 to clinical trials? It cost on average about $14,000 to get a patent. Why would anyone with a brain cell left in their head invest that kind of money when China produces tons every year and has for many years? Now, just of get through clinical trials it cost around $20 million. Again a whole lot of money spent on a peptide that anyone can make and is already being sold on the internet by 1000's or peptide dealers. Will the medical community use BPC 157 if it is FDA approved? Well you gotta get insurance companies to cover it and then talk doctors in to believing that sometimes surgery is not necessary. How much money is lot thinking this way? No one in the medical community is going to waste time and money doing a lot of research on anything that won't make money. Its kind of like doing research on exercise science and supplements. Find money is impossible.

One thing people who have never been a competitive athlete don't understand is often times, what happens in the trenches is much more valid that anything that goes on in a labs. Science has done quite a few studies on Usan Bolt. Oh is spring form is biomechanically incorrect. REALLY? How can you tell the fastest human he is doing it wrong? Perhaps science need to go back to the drawing board and figure out why athletes are successful doing what they do. Instead they go back and study untrained individuals and tell athletes you are doing it all wrong.

On the BPC 157, it goes like this.....if you believe it needs to compete a clinical trial and approved by the FDA, then by all means it is your body, don't take it. I took the leap of faith a long time ago and still use it when I am injured. As most athletes do, we take chances trying to find things that give us an edge. If it works we use it, those that don't get tossed out and on to the next one. Most here are not athletes and never have been so my advice is if you have a grade 1 or grade II muscular injury you will have a choice, Go to a doctor, pay for a MRI, go through physical therapy/surgery until you are healed or take a chance using one of the may peptide that are used frequently for healing. As I mentioned, I used PEG-MGF and IGF-1 Lr3 to speed up recovery after quadriceps reattachment surgery in 2010. My surgeon did not even want to know what I was doing but damned if I was not back doing full squats after 5 week. My surgeon said he had done quite a few of these surgeries on professional athletes and never seen anyone recovery as quickly. Why, because I was willing to go outside of the box and use things that were not FDA approved, and no studies backing my techniques and certainly no clinical trials. Ricky? Moist definitely, but that is how athletes think.

The right to try is not for everyone. It has to be a personal decision and you accept the consequences good or bad, just like taking an mRNA vaccine.

BPC 157, also known as Body Protection Compound 157, is a peptide that was first discovered in the gastric juice of humans in the late 1990s. It is a 15 amino acid long peptide that has been thought to have a variety of beneficial effects on the body, including promoting healing of injuries, reducing inflammation, and protecting the gut. Neither gastric juices or genetically modified bacteria are use to synthesize BPC 157 in a lab.

BPC 157 was discover buy research conducted by Dr. Slawomir Makowski and his team at the University of Zagreb in Croatia. They were studying the healing properties of gastric juice when they discovered the peptide, which they found to be particularly effective at promoting the healing of injuries to the stomach and intestines.

The amino acid sequence of the natural gastric substance were analyzed is used to synthesize BPC 157. It has been synthesized in the lab by using the amino acid sequence Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val. A more technical description, peptide synthesis is the production of peptides, compounds where multiple amino acids are linked via amide bonds, also known as peptide bonds. Peptides are chemically synthesized by the condensation reaction of the carboxyl group of one amino acid to the amino group of another. This peptide has a molecular formula of C62H98N16O22.

How peptides are synthesized:

Conclusion, BPC 157 is sold in gray markets, Its not approved by the FDA, there is very little human science on it, no clinical trials, it can't even be sold for human use. However there is tons of anecdotal evidence that it works to heal injuries. It is your body and your choice to use substances like this. You get either the benefits or the consequences. So it has to be your choice. If you need clinical trials and the FDA to approve this substance, then by all means DO NOT use it. Its too late for me, I made the decision over 12 years ago. There is not one peptide or SARM I have not used and I tossed those that did not work and kept the ones that do work. What works for me may not work for anyone else. But it is your right to try or not. Buying these products is not illegal, but selling them for human use seems to be against the FDA rules. They are also illegal if you compete in any sport that uses WADA drug testing standards. So buyer beware!

 

[sammmy]

This thread is not about FDA or CDC approvals or what anyone thinks of their process.

I personally do not care if a drug is not FDA approved, as long as it has consistent research demonstrating that it is safe and effective. This is not the case of BPC-157. The "research" on BPC-157 appears inconsistent, contradictory, and frankly speaking manipulated.

This "research" is coming from Croatia and China, which we can guess are the main manufacturers and have financial interest to exaggerate the positive results and downplay the dangers, which they didn't even bother to investigate - not even a mice study on the possibility to enhance tumor metastases. First the "research" claimed it enhances VEGF because that speeds up wound healing, then another "research" claims it suppresses VEGF because otherwise that would lead to tumor metastases. So which one is it?

Medicine in Croatia and China is not under the jurisdiction of the US FDA and the studies there are not at all expensive to do - yet they are either missing or not finishing successfully. Case report studies do not require any funding, yet are missing on BPC-157.

Getting an US patent is obviously not that expensive either because BPC-157 has such patent in 2017 granted to a Slovenian company Diagen. The patent is for salts of BPC-157 that are stable at acidic pH (wasn't BPC-157 supposed to be stable since it is "natural part of gastric juice"???):

WO2014142764A1 - New stable pentadecapeptide salts, a process for preparation thereof, a use thereof in the manufacture of pharmaceutical preparations and a use thereof in therapy - Google Patents

New Stable Pentadecapeptide Salts, a Process for Preparation Thereof, a Use Thereof in the Manufacture of Pharmaceutical Preparations and a Use Thereof in Therapy The present invention discloses new stable pentadecapeptide salts of formula (I): Gly Glu Pro Pro Pro Gly Lys Pro Ala Asp Asp Ala Gly...

patents.google.com

 

[sammmy]

Actually the US patent was obtained in 2013:

US9850282B2 - Stable pentadecapeptide salts, a process for preparation thereof, a use thereof in the manufacture of pharmaceutical preparations and a use thereof in therapy - Google Patents

Stable pentadecapeptide salts of formula (I): (I) SEQ ID NO 1 Gly Glu Pro Pro Pro Gly Lys Pro Ala Asp Asp Ala 1               5                   10            Gly Leu Val · n BAA         15 wherein n means 1, 2 or 3, and BAA means...

patents.google.com

 

[Deleted member 43589]

So @sammmy, exactly what is the purpose of this thread? You have posted on several occasion about how you think BPC 157 is worthless and any research around it is sketchy. So what is the purpose? A group of scientists wanted to investigate a product and started clinical trials and then stopped the process. This is all we know other than conjecture. Your guess is as good as mine and neither or us has any facts. So until one of us find out the facts, what is the purpose of any further postings?

Patents....Sammy my best friend has several patents, depending on how complex the patent is, the fee can go around $2000. Medical patents are up there. You will also have research and legal expenses through patent attorneys that could cost up to $15-16,000. As you found through your posting, medical patents are very technical and cost big bucks to produce. All to turn around and your top secret proprietary information is already being sold and produced in China. Before you can get the patent approved the product is being sold all over the internet. There goes your investment. Only very large pharmaceutical companies can deal with issues and fight those who steal their proprietary rights. Legal fees to fight patent infringement are very expensive. When it comes to going after Chinese business, IMPOSSIBLE. No one is going to invest this kind of money into a peptide that can be synthesized by any lab with the synthesis equipment.

Retatrutide (LY-3437943) is an experimental drug for obesity developed by American pharmaceutical company Eli Lilly. As of now they are in the middle of stage II clinical trial. Also known as GGG Tri-agonist, GLP-1/GIP/glucagon tri-agonist, or LY3437943, this injectable medication is hopefully set for FDA approval. Yet I can buy it right now. As much money as Eli Lilly has spent, this product is already being sold on the black market by the Chinese. Retatrutide is in the same class as other weight loss drugs like Semaglutide (Novo Disk) and Tirzepatide (Eli Lilly). All of these products were sold black market and used by 1000's long before the FDA every approved the drug for use. People who used them took the risk only because other reported the tremendous weight loss. Why do people take such risks?

Sammy as I said, you have made it clear through quite a few posting that you don't want to use BPC 157. This is most likely why you started this thread in an attempt to cast some negative light on the product because you don't care for it. The fact is YOU don't have any idea why the trial was cancelled and until you do have facts, what you are saying is untrue and unfair to those who are researching it.

 

[Deleted member 43589]

Total cost of developing a drug ins the USA - $2.6 billion

Drug development cost United States 1970-2016 | Statista

The cost of drug development totaled approximately one billion U.S.

www.statista.com

90% of clinical trails fail

 

[sammmy]

Proving drug safety and effectiveness requires good quality research, not an expensive trial for FDA approval, so that excuse for the really low quality, missing, or contradictory "research" on BPC-157 doesn't fly. Nobody wants it to be FDA approved, but everyone should demand it is well researched, which it is currently not.

You clearly have no idea what a case study is. Case studies are extremely cheap and are just the doctor reporting on results of a patient that may have bought the drug themselves and used it. This usually costs $0 to the researcher.

Why China and Croatia do not have even case studies is the main question. It could be because the drug is not that effective, or they know it is dangerous, or because they don't want to popularize it only for someone else in US to market it.

If you believe BPC-157 is "safe and effective" based on that garbage low quality contradictory research from China and Croatia, basically any drug is good for you.