The Truth about BPC-157: Why it isn’t FDA Approved and Why It Will Never Be

BPC-157 is one of the hottest compounds on the market right now with many people, especially in the bodybuilding and functional medicine space swearing by its beneficial effects for gut health and joint healing, among a whole host of other proposed possible benefits.

It is not however, a FDA approved pharmaceutical. Clinicians are prescribing it through compounding pharmacies without a clear, approved indication and people are buying it as a “research chemical” for “not human consumption” online.  After ending up on the FDA “do not compound” list in late 2023, sources of injectable BPC have become scarce.  Some have relabeled it as Pentadecapeptide Aringate or PDA (changing the acetate to an arginate) and are prescribing it for subcutaneous administration that way, while the confusion about its status has led to a vibrant oral capsule market for BPC in what appears to be a grey area of legality.  (did the FDA accidentally make this into an OTC supplement by adding it to the do not compound list?)

So if it's so effective, why is it not approved by the FDA for human use? Is there some sort of conspiracy against “good” medicines that have potential to “heal” by big pharma? Are they worried it may cut into the profits of their other drugs, such as NSAIDs, PPIs, and biologics?

While those who stand to profit from BPC-157 sales on the internet would have you believe that, the answer is no.

As far as I can tell in my deep inquiry there is no global conspiracy against BPC-157. There are, however, simple economics of drug development processes that make it so BPC-157 likely will never go through the full process of drug approval because of financial incentives.

I would even venture to believe that a pharmaceutical company like Merck would LOVE to have the exclusive rights to BPC-157. However, because of the patents being filed and the way patents work on small peptides, pushing BPC through the entire FDA product, which would cost millions of dollars, is not going to happen.

Let’s look at how we got here:

BPC-157 is not new.  Croatian researchers isolated the full, larger peptide BPC in 1998 from gastric juices and found the 15 amino acid sequence, BPC-157 to be the active part responsible for its clinical effects (the story of how it was discovered is fascinating, but that is a conversation for a different day if there is enough interest, let me know below). The first human safety study on health volunteers was conducted in 2002 and a “phase 2” double blind, randomized clinical trial (small and not sufficient for US phase 2 purposes) was conducted in 2005 with BPC-157 enemas for ulcerative colitis, with some promising effects (see research name PL 14736 to find the references).  Yes, there were human studies with BPC-157 showing no known adverse effects and safety, however since those two initial trials it appears almost all the data has been in animal models, with a few, small studies here and there for human use.

If only 10% of the animal data on BPC-157 ends up being valid and applicable to humans, this is a blockbuster drug/compound that has great potential for human use.  But this also may be part of the problem of pushing BPC through regulatory constraints (yes BPC-57 is suffering from success).

To get a drug FDA approved, a company must conduct phase 1, 2 and 3 clinical trials proving safety and efficacy of the compound through a laborious, multi year and extremely costly process.  We’re talking a decade or more and hundreds of millions of dollars.  The drug needs to be proven to work for a specific disease indication to get approval, while BPCs effects seem to be pleiotropic and the research cannot seem to focus on one, singular disease case to focus on.

Diagen is the company that currently owns the BPC-157 US patent (the European patent is expired), which was filed in 2012, approved in 2017 with an expected expiration of 2033.  These are all the conditions listed in the patent:

Conditions and Disorders:
1.    Stress-Related Diseases & Disorders
2.    Gastrointestinal Conditions
•    Ulcers in any part of the gastrointestinal tract
•    General anti-inflammatory activity
•    Gastrointestinal inflammatory diseases
•    Crohn’s disease
•    Acute pancreatitis
3.    Organoprotective Needs
•    Diseases, conditions, or disorders requiring organoprotective activity
4.    Viral Infections
•    Hepatitis A
•    Herpes strains
•    Influenza A
•    Arthropod-borne (ARBO) viruses, including:
•    Tick-borne encephalitis
•    West Nile fever
•    Dengue (types 1-4)
•    Cytomegalovirus (CMV)
•    Lymphocytic choriomeningitis (LCM) virus
•    Feline leukemia virus
5.    Oncology & Tumors
•    Melanoma and related tumors
6.    Tissue & Wound Healing
•    Accelerated healing of wounds, burns, and bone fractures
•    Regeneration of ruptured nerve linkages
•    Achilles tendon and muscle repair
•    Spinal cord injury recovery
7.    Nitric Oxide (NO)-Related Disorders
•    Hypertension
•    Hypotension
•    Anaphylaxis
•    Circulatory and septic shock
•    Thrombocyte aggregation
8.    Neurological & Autoimmune Disorders
•    Multiple sclerosis
•    Myasthenia gravis
•    Lupus erythematosus
•    Neuropathy
•    Somatosensory nerve dysfunction
•    Asthma
•    Rhinitis
•    Pemphigus
•    Eczema
9.    Neurochemical & Substance-Related Disorders
•    Catecholaminergic dysfunction
•    Schizophrenia
•    Withdrawal effects from amphetamines, drugs, and alcohol
10.    Corticosteroid & NSAID-Related Disorders
11.    Ophthalmological Conditions
•    Squamous degeneration of the macula
12.    Vascular & Circulatory Needs
•    Conditions requiring rapid reorganization of blood supply
13.    Animal Health & Reproductive Enhancement
•    Weight gain in animals
•    Increased sperm stability in storage (in animals)
14.    Liver & Pancreatic Conditions
•    Hepatic and pancreatic lesions

While this list seems impressive, BPC-157 would have a much easier time coming to market if one disease state was focused on and pushed through the regulatory process. Then, more off label uses could be found.

So why isn’t Diagen pushing this amazing molecule through regulation if its so effective? Are they cash strapped? It appears so, as they are actually trying to sell the BPC patent.

So then why doesn’t another big pharmaceutical company swoop in, buy the patent, and use their exhaustive funds to get BPC FDA approved, then make billions of dollars selling the drug to an already interested market. Because big pharma is evil? Not really.

If BPC-157 was purchased today, the patent would likely expire in 2033 before the phase 1-2-3 trials would be completed, at which point all the generic manufacturers would be able to push the product on the back of all the hard work a pharmaceutical company can do (I’m not sure if FDA approval would push the expiration of the patent back, but even then it would not be so financial lucrative).

On top of this, the market is already flush with BPC-157.  Why would a company work so hard for this drug when people are getting it cheaply through compounded and grey/black market sources. Diagen seems unable to go after and sue all these people despite owning the patent, while Eli Lily with their deep pockets is going after GLP-1 compounders.

To complicate things further, over the last few years, several patents have come up for different use cases and applications of BPC-157.  Because of the way patents for small peptides work, anyone can make a small change to a molecule, adding one amino acid here or there and now have a competing product that would not fall under the patent.  For example,  N-acetylated versions of BPC-157 will likely be pushed through for patent soon.  Why would anyone spend a decade and hundreds of millions of dollars when tomorrow someone will make a small change to it and have their own product?

To get it FDA approved would require someone who so believes in the effects of BPC-157 to cough up a nice chunk of cash and support the research for its potential (I’m still bullish) restorative effects.  To get it approved, you would need to:

1. Buy the patent (its for sale)
2. Figure out a specific disease indication to apply for BPC-157 approval
3. Hire a research team to run phase 1, 2, 3 trials

The financial incentives make it so that BPC-157 will likely never go through the full FDA approval process, which is a shame given how promising this compound is.

It is also a shame given the risk calculations in my mind for these small, short chain peptides is far different than a traditional pharmaceutical drug, given this is, in some ways, replacing/replenishing an endogenous gastric peptide that appears to decrease with age/stress.  Given the human trials in early 2000’s showed no adverse events, despite using enormous doses, and the animal data corroborating this, many practitioners feel comfortable prescribing/recommending BPC-157 (I am not making such a recommendation).

The best hope for BPC is that this new regulatory environment allows for oral versions of the peptide to continue as OTC supplements (no GRAS indication has been given) while injectable forms are prescribed with modifications through compounding pharmacies as PDA or N-acetyl-BPC-157.  And if we are lucky, someone with deep pockets will experience beneficial effects of this drug and decide to fund these studies themselves for the betterment of humanity.

This could easily go south if new safety concerns were brought forward for oral/injectable forms or impurities in the production by those who are seeking to profiteer off of this compound lead to adverse events.  The large telehealth and compounding companies could fund this research to help people become more comfortable with using this compound.

If you’re interested, you can buy the BPC-157 patent here, before it expires early next decade. bpc157.si/bpc-157-stable…

In summary:
- BPC-157 is a promising compound for different cytoprotective uses
- It is not FDA approved for human use
- There is not some shadow cabal blocking the use of BPC-157
- Financial incentives make it so that BPC-157 is challenging to push through the regulatory process
- It will likely never receive FDA approval, but will be available in some form as oral supplement or through compounding pharmacies, with some modification

This is not medical advice.  I am not suggesting you use BPC-157. It is not a FDA approved as a drug and the safety profile is still not clear.  Discuss this with your doctor, with the hope that your doctor is aware of what BPC-157 is or find a doctor that is comfortable with this compound. Slightly longer version with sources hyperlinked available on my blog

Progress isn’t always good

We replaced incandescent lights with LEDs for “energy efficient”

But we deprived ourselves, and especially our eyes, of the energy needed to recharge our mitochondria everyday: infrared lights

Sometimes we have to step back to move forward Incandescents have a lot of red and bleed into infrared spectrum, that’s why they give off heat

LEDs are rich in blue and other short wave lengths and poor in red/infrared

Red and blue must be balanced for health

Daylight is ideal

TESTOSTERONE and XY chromosomes are NOT enough to make someone a "normal" man

You need:

- XY chromosomes
- SRY gene
- sensitive androgen receptors
- functioning LH receptors
- 5 alpha reductase
- normal aromatase
- 17β-Hydroxysteroid dehydrogenase III
+ more

Anything missing can lead to DSD (differences in sex development)

Let’s examine the step by step process and what happens when things go off course 👇🧵
disclaimer: this is not a commentary on who is or isn't a man

This is just a step by step journey of all the things that need to go right for "normal" masculine development, from conception to birth to puberty

the concept of intersex is complex, and researching this blew my mind

DSD, sometimes referred to as intersex is often distinctly different than transgender

ok lets begin 👇

The FDA dropped the hammer on peptides a few weeks ago 💉

But they left 𝒐𝒏𝒆 peptide off the kill list 🧪

And it happens to be the peptide I’m most excited about 👨‍🔬

It’s about to be ̶G̶o̶l̶d̶ COPPER Rush 🥉

This is the ULTIMATE thread on GHK - Copper peptide 👇 Disclaimer ⚠️

As always, this isn’t medical advice

I’m not your doctor. This is just a summary of my research and experience

And I don’t benefit financially from any of the copper peptides listed here

Proceed at your own risk

Let’s dive in

Gene therapy i̶s̶ ̶c̶o̶m̶i̶n̶g̶ is here 🧬

The first genetically modified humans are already walking among us

Building more muscle, losing fat, and de-aging 💪

For $25,000, you too can get gene therapy 💉

What's the catch?

This is the ultimate gene therapy thread 🧵👇
Before we dive in, the usual:

This is not medical advice

I am not affiliated with these gene therapy people

Learning about it just like you guys are

They make lofty claims, we will see if their claims hold true

All I know is this is exciting!

This is the thread 🧵 I never thought I’d have to write

But with so many people cheering on for WW3 and our politicians treating human blood so cheaply

☢️HOW TO SURIVE NUCLEAR FALLOUT ☢️

(You’re going to want to bookmark 🔖 and PRINT 🖨️ this out in case the internet goes away)👇
Disclaimer: I'm not a nuclear expert. Just a doctor doing research.

Went through all the FEMA, WHO, US Gov and research papers to see what the guidelines are and what was tried in the past

This is what I'm going to do to try and save my family

General information. NOT MEDICAL ADVICE

Nuclear war is terrible and I pray we never have to see this

Any approach for young male mental health (18-45) that doesn’t involve TESTOSTERONE is short sighted

T levels and pulsatile release is CRUCIAL for male mental health

This is deeper than checking a lab test 🧪

A therapist must understand what lifestyle events trigger T release👇
Sure, higher testosterone levels in man are important but this is not just a simple algorithmic check of a value

Why is testosterone released? What purpose does that serve?

How does testosterone help a man maintain his social standing?

Just took the biggest exam of my life 📝

Final board exam

9 HOURS 🕐

Culmination of 12 years of work 👶👴

Here's what I took/did to prepare for exam day 👇🧵 Usual disclaimer: Ain't medical advice

If you take all of the things I took and go into an arrhythmia I'm not responsible

I have a high caffeine tolerance and am a master of caffeination

I've taken 5+ such exams and have my flow down now

I have been seeing a LOT of CANCER in younger and younger patients 🦀

Some even in their early 30s 😪

And I’m not the only one noticing it 👀

Here’s what I think is causing a dramatic rise in YOUNG cancer cases 👇🧵 Disclaimer first: I’m a doctor but I’m not YOUR doctor. None of this is medical advice

I also am not a oncologist. This is just what I’ve been noticing in my young career and connections I’ve made

If I knew the absolute answer, I’d win a noble prize

There will be other… twitter.com/i/web/status/1…

Just finished a grueling medical residency 🏥

Supposed to be the hardest years of your life. You age quite a bit (pics day 1 vs graduation)👴

But there are biological and psychological tricks to make it much smoother 🧑‍🔬

This is how I played residency on EASY mode 👇

🧵

1. Understand and Master Circadian Biology🌞🌚

Residency involves:
- constant day/night shifting
- inconsistent schedules
- 24+ hr shifts

This is constant jet lag without travel ✈️

Rough on the body

Becomes WAY easier if you know how to shift your circadian clock at will

Everyone is talking about RFK Jr's steroid stack 💉💊

What’s way more interesting is the WILD stack of PRESIDENT JFK 🦅 🇺🇸

Spoiler: A LOT OF DRUGS 💊, including Testosterone 🐂

Let’s dive in 👇

This is the crazy story of the intersection of medicine, politics and history 🏥

Buckle up 💺

This is the closest we ever came to NUCLEAR war and a doctors had the president on so many psychotropic medications 💥

Most people DO NOT hydrate properly during #Ramadan 🌙

End up drinking a ton of water at suhoor, then urinating like a horse for the next few hours 🐎

End up thirsty and lightheaded

We aren’t camels, we are humans 🐫⏩️ 👤

Here’s the Ultimate Ramadan Hydration Guide 👇 In order to improve hydration, we want to increase the amount of water we absorb into our blood and cells

If you just drink 4 cups of water alone, very little of that is going to get absorbed

But there are some tricks we can leverage 👇

One of the SCAMs of modern medicine is that we tell patients generics are just as good

That might have been true before

It clearly is not now

I have experienced this myself with certain medications

yahoo.com/news/people-ad… There have been scandals of certain generic drug manufacturers overseas gaming the system and producing empty drugs at best, or drugs with several impurities at worst

The brand name meds are going to work better… but sometimes those are prohibitively expensive

Is it ethical to prescribe a patient a placebo 💊 pill, knowing they will likely improve on their own? Even if patients KNOW it’s a placebo, sometimes the empty pill still works

ncbi.nlm.nih.gov/pmc/articles/P…

Damn just heard that one of the guys at our BJJ gym and 4 friends OD’d on fentanyl after doing lines of cocaine 😢 . 4 deaths….

1. Stay away from recreation drugs, if not for the harms of cocaine itself, but for for the fentanyl adulteration

2. WHY IS FENTANYL IN COCAINE? Who… twitter.com/i/web/status/1… Opioid epidemic is costing so many lives…

The history of such an epidemic has blood hands from both the medical establishment, government policy and drug cartels. It’s a perfect storm

We need to aggressively treat and eliminate MOSH 🫃

Male obesity-related secondary hypogonadism

This is one of the biggest drivers of the Low T epidemic

Forget the “testosterone supplements” 💊 So many avenues for obesity to destroys testosterone, including

- HPG suppression through aromatization
- HPG suppression through adipocytokines
- OSA
- leptin resistance
- insulin resistance/SHBG decrease

Worried about endocrine disrupting chemicals (EDC)?

Many of these are lipophilic

This means they are stored in the adipose (fat) tissue

Another reason to keep body fat% ⬇️⬇️⬇️

⬆️ body fat = ⬆️ ability to accumulate these chemicals and have them slowly leak into your 🩸 For men, extra adipose tissue is a DISASTER

- lowers HPG production = less testosterone
- secrete adipocytokines = more inflammation
- store EDCs

Extra adipose tissue is EVIL

New SLEEP APNEA treatment 😴

No Bane 😷 needed

Electronic stimulator inserted surgically 🔪 to move your tongue based on breathing pattern👅

Keeps airway 🫁 open

Connects to hypoglossal nerve in 🧠 stem

For people BMI <32

Called INSPIRE (excellent branding) Taking advantage of the fact no one wants to wear a mask

This is a secret military trick I use

Fast for 24 hours before changing time zones

Flight food sucks anyways

Your liver, intestines, stomach also have a circadian clock

Meal timing can help reset their clock as well

https://twitter.com/Thomashornall/status/1606036684512014336

You will get hungry at the old time zone. When I go night shift/travel I use this to my advantage

Fast 24 hours. Then eat "breakfast" at the new time to tell my liver it's DAY TIME WAKE UP

Getting brain and digestion on new time zone is biohacking

Prolonged FASTING is/has been very popular

Most people have no idea what their doing during the fast

But even worse, they have no idea how to break it properly

As promised, this is how I break a long fast 👇 “Any fool can fast, but it takes a wise person to break a fast”

The hardest part is not the avoidance of food for multiple days, it's not refeeding properly

I have broken the fast like a fool and a wise person, and the difference is astronomical

CARNITINE 🥩is becoming an ESSENTIAL supplement 💊 for men

The more I look at it, the more confident I become of this

People are concerned about testicular health? The one thing that seems to be protective of testicular health/sperm even in the face of CHEMOTHERAPY??

Carnitine Improve fertility for both men AND women?

Carnitine!

Comparable effect to fertility drug Clomiphene

Men: onlinelibrary.wiley.com/doi/full/10.11…

Women: ncbi.nlm.nih.gov/pmc/articles/P…