Sleep & stress

DSIP

People use DSIP to try for deeper, more restoring sleep. Small studies from the 1980s tested it for insomnia.

One-time step

Research use only

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Keep scrolling: the tick box is after part 5.

Quick guide

Start here · First few nights (optional gentle start)

100 mcg

1.5units

= 112.5 mcg, the closest mark to the 100 mcg dose

051015202530 1.5

Draw to the 1.5 half-unit mark, the closest half-unit mark to the exact 1.3 units; it gives 112.5 mcg. Use a 0.3 mL U-100 insulin syringe with half-unit marks.

After that, if you are not groggy the next day, step up to the store dose of 250 mcg (3.5 units, which gives 262.5 mcg). See the step-up plan.

Range 100–500 mcg

Mixed for you

Your 15 mg vial comes mixed with 2 mL bacteriostatic water. Each unit is 75 mcg.

The 250 mcg store dose falls between syringe marks: draw to the 3.5-unit half mark, which gives 262.5 mcg.

  • How often

    Once a day

    Every night (7 days a week) during each 4-week on-cycle

  • When

    In the evening, 30 to 60 minutes before bed

  • Where

    Belly or thigh

    Under the skin

  • Storage

    In the fridge (2-8 °C / 36-46 °F)

    Use within 90 days

  • Cycle

    4 weeks on · 4 weeks off

    Full course: 1 vial

Status
Not FDA-approved. The FDA lists DSIP (under the name emideltide) among substances for compounding that may present significant safety risks, and says it lacks enough information to know whether it would cause harm in people.32
Evidence
Small human studies from the 1980s, mostly with DSIP given into a vein (IV), with mixed results. Injection under the skin has not been studied in people.
Week by week

What to expect

  • Week 1-2: Users often report deeper sleep first
  • Week 2-4: Finish round 1; take stock of your sleep
  • Week 4-8: Break: some sleep worse for a few days
  • Week 8-12: Round 2 if round 1 helped
  • Side effects: Users: groggy at higher doses; 911 for chest pain; see Side effects
More on each stage
Week 1-2
Round 1 (on). Community users most often report deeper, more restoring sleep. Some fall asleep a little faster, wake less in the night, or have more vivid dreams. In 1980s IV studies of insomnia, sleep improved more after repeated doses, with normal sleep structure after about four doses. Those doses were much larger and went into a vein. Next-day grogginess is one of the most commonly reported side effects, and users link it to taking too much.
Week 2-4
Finish round 1 at the end of week 4. Take stock of how your sleep has changed. Rebound poor sleep after stopping is reported mostly after more than 2 to 3 weeks of nightly use.
Week 4-8
Your 4-week break (weeks 5 to 8). Some users report worse sleep for several days after stopping. In small 1980s studies, better sleep held for a night to a week after the last dose, and in one open study of 7 people for 3 to 7 months. Use the break to see whether your sleep holds up on its own.
Week 8-12
Round 2 (weeks 9 to 12), only if round 1 helped. No study has followed people using DSIP this long, so long-term effects are unknown.
Side effects
Most often next-day grogginess at higher doses, a few nights of worse sleep after stopping, vivid dreams, or a mild headache. Stop and get help right away for swelling of the face or throat, trouble breathing, chest pain, or a racing heartbeat that does not settle.

Based on what people report in the community sources below. Results vary, and many responses are anecdotal.

Why people use it

Benefits and research

  • Better sleep in insomnia

    Clinical trial

    In a double-blind study of 14 middle-aged people with long-term insomnia, 7 nights of DSIP improved night sleep and daytime alertness. The study used IV doses.2

  • Sleep without a drugged feeling

    Human study

    In 6 healthy volunteers given a slow IV drip in the morning, total sleep rose by 59% over the next 130 minutes compared with placebo. Detailed tests found no sedation of the kind sleeping pills cause, and no side effects were seen.8

  • Longer-lasting sleep improvement

    Human study

    In 18 people with long-term insomnia given 6 IV doses over a week, all had normal sleep patterns by the end of a one-week follow-up. In an open study of 7 people with severe insomnia given 10 injections, sleep returned to normal in 6 of them for 3 to 7 months.45

  • Withdrawal symptoms

    Human study

    In an open hospital study of 107 patients in alcohol or opiate withdrawal, symptoms went away or improved quickly after IV DSIP in 97% of opiate and 87% of alcohol patients who could be assessed. Anxiety eased more slowly. A few patients had headaches.10

  • Lower stress-hormone response

    Animal/lab study

    In rats, DSIP reduced the stress hormone corticosterone released after a signal from the brain's stress system (CRF). It seemed to act at the pituitary, the gland under the brain that controls stress hormones.23

  • Deeper sleep, as users describe it

    Community report

    Deeper, more restoring sleep is the benefit community users report most consistently. Some also report falling asleep a little faster and fewer night wakings. Users describe it as not a strong sedative.33

What it has been studied for

  • Long-term insomnia (small double-blind trials)123Clinical trial
  • Insomnia over longer follow-up (small open studies)45Human study
  • Alcohol and opiate withdrawal (open hospital studies)1011Human study
  • Chronic pain: migraine, vasomotor headaches, tinnitus, and pain attacks (pilot study of 7 patients)12Human study
  • Narcolepsy (a single patient)13Human study
  • Add-on to anaesthesia (24 women; DSIP made anaesthesia lighter, not deeper)15Clinical trial
  • Recovery of movement after stroke29Animal/lab study
  • Seizures, as an add-on to valproate28Animal/lab study
In the body

How it works

DSIP is a short chain of 9 building blocks (amino acids). In 1977, scientists found it in the brain blood of rabbits kept asleep in a lab. It is named for the deep sleep ("delta" sleep) it caused when given to other rabbits. Nobody knows exactly how it works, because no gene or doorway (receptor) for it has been found. In animals, it gets from the blood into the brain, calms nerve cells that are too excited, and turns down the stress response. In rats, blocking the body's own DSIP stopped the extra deep sleep and growth hormone that normally follow lost sleep.

1 2 3 4 Brain Pituitary Heart Cells
Tap an item below to show it on the body.
  1. Gets from the blood into the brain (dog and guinea-pig studies). In rats it quieted brain cells that the brain's main 'go' signal normally fires up, and early studies found it brought on deep sleep in rabbits, rats, and mice (rat study).

  2. Lowered a stress hormone after a stress signal, acting at the pituitary gland (rat study). Blocking the body's own DSIP stopped growth hormone rising after lost sleep (rat study).

  3. In a small human study under anaesthesia, a dose into a vein raised heart rate. It also lowered heart-rate variability, a sign the body's calming 'rest and digest' nerves were less active.

  4. Helped the cell's power plants (mitochondria) in rat brains make energy more efficiently, and protected them when rats were short of oxygen (animal study).

Peak, half-life, clearance

Pharmacokinetics

Peak
Not established in humans for injection under the skin. In 1980s studies where DSIP was dripped slowly into a vein, sleep came on after about 1 hour; one study saw sleep promoted only in the second hour, with a slight alerting effect in the first.
Half-life
Not established in humans. In lab tests, enzymes in human and rat blood broke DSIP down quickly. In lab tests on brain tissue, enzymes split DSIP apart with a half-life of 15 minutes. Its effects outlast it: a summary of five human IV studies reported effects lasting up to 20 hours.
Cleared
How long a dose takes to leave the body has not been measured in people. Injected DSIP disappears quickly from blood because enzymes break it down. The body's own DSIP-like material in blood was found bound to a larger protein that protects it from breakdown.

Half-life is how long it takes the body to remove half of a dose.791917

Research and community

Dosing guidance

Starting dose

100 mcg

1.5 units

= 112.5 mcg, the closest mark to the 100 mcg dose

Store dose

250 mcg

3.5 units

= 262.5 mcg, the closest mark to the 250 mcg store dose

Higher

500 mcg

6.5 units

= 487.5 mcg, the closest mark to the 500 mcg dose

Once a day. In the evening, 30 to 60 minutes before bed. Every night (7 days a week) during each 4-week on-cycle. Units are for a 15 mg vial mixed with 2 mL water (7.5 mg per mL).

Step-up plan

WhenDoseUnits
First few nights (optional gentle start) Start here100 mcg1.5 units, which gives 112.5 mcg
After that, if you are not groggy the next day Store dose250 mcg3.5 units, which gives 262.5 mcg

What the community uses

Community report
  • Lower end · intermittent; avoid rebound

    100-250 mcg, 3 times per week

    An intermittent protocol some use to avoid the rebound insomnia a few report after several weeks of daily use.33

  • Most common · standard sleep-depth protocol

    100-200 mcg once daily before bed

    The standard community sleep protocol — most often described as deepening sleep rather than forcing onset. Some report next-day grogginess above 300 mcg.33

  • Higher end · higher for severe sleep issues

    250-500 mcg once daily before bed

    A higher-dose protocol for severe sleep issues — offset by reports of next-day drowsiness, so the community generally starts low.33

  • Standard sleep protocol (not tested in trials)

    100-200 mcg under the skin once a day, 30-60 minutes before bed, for 2 to 4 weeks, then a break. The most common starting dose.33

  • Higher-dose sleep protocol (not tested in trials)

    250-500 mcg under the skin once a day before bed, for 2 to 4 weeks. Some users report next-day grogginess above 300 mcg. The store dose of 250 mcg sits at the low end of this range.33

  • Intermittent protocol (not tested in trials)

    100-250 mcg under the skin 3 evenings a week on non-back-to-back days (for example Monday, Wednesday, Friday), for 4 to 6 weeks. Used to lower the risk of tolerance and rebound.33

Research protocols

  • Insomnia trial, double-blind (16 people)

    25 nmol per kg of body weight by IV, given in the afternoon before each of 3 nights, against a placebo.1

  • What the research dose means in micrograms

    The IV studies used 25-30 nmol per kg, roughly 21-25 mcg per kg of body weight: about 1,500-1,750 mcg for a 70 kg (154 lb) person. That is far more than the store dose of 250 mcg under the skin. The two routes have never been compared.33

  • Insomnia, one week of treatment (18 people)

    6 doses of 30 nmol per kg by IV over one week, then a one-week follow-up.4

  • Healthy volunteers (6 people)

    25 nmol per kg as a slow IV drip in the morning, against a placebo.8

  • Chronic pain pilot (7 patients)

    IV DSIP on 5 days in a row, then 5 more injections every 48-72 hours.12

DSIP research is dated and limited, and community subcutaneous doses are far lower than the doses used in the old research literature. Rebound insomnia after stopping is reported. Long-term safety of repeated use is unknown.

Dosing guidance built from the cited research and community reports. It is not a prescription.

On and off

Cycling

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8

On: 4 weeks Break: 4 weeks

A full course at the store pace takes 1 vial. A mixed vial keeps for up to 90 days.

Why the break helps

No study has tested on-and-off cycles for DSIP. The research courses were short: 1 to 10 doses. In small studies, better sleep lasted after the last dose, for a night to a week, and in one open study of 7 people for 3 to 7 months. Community users run 2 to 4 weeks and then take a break. Some report worse sleep for several days after stopping, mostly after more than 2 to 3 weeks of nightly use. The break lowers that risk, lets you see whether your sleep holds up on its own, and limits nonstop use of a compound with no long-term safety data. If you get rebound poor sleep, try a shorter round next time or the community's 3-nights-a-week schedule.

What to watch for

Side effects

Common

  • Next-day grogginess, most often at doses above 200-300 mcg (community reports)

    What to do Drop to 100-200 mcg (the 1.5- to 2.5-unit marks). Do not drive or use machines while drowsy. If it keeps happening, stop.

  • Worse sleep for several days after stopping (rebound), mostly after more than 2-3 weeks of nightly use (community reports)

    What to do It usually passes. Do not restart early to fix it. Next round, use a shorter cycle or the 3-nights-a-week schedule.

  • Vivid dreams (commonly reported by community users)

    What to do Usually harmless. Lower the dose if it disturbs your sleep.

  • Mild headache (reported by a few patients in a hospital study)

    What to do Drink water and rest. If headaches keep coming back, lower the dose or stop.

  • Redness or mild soreness where you inject

    What to do Rotate sites each night. It should fade within a day or two.

Stop and get help

  • Allergic reaction: swelling of the face, lips, or throat, trouble breathing, wheezing, or a widespread rash. The FDA flags a risk of immune reactions to compounded DSIP.

    What to do Stop DSIP and call 911 (or your local emergency number) right away. Do not take it again.

  • Racing or pounding heartbeat that does not settle, chest pain, or fainting. IV DSIP raised heart rate in a small human study.

    What to do Stop DSIP and get medical help the same day. Call 911 for chest pain or fainting.

  • Infection where you inject: redness that spreads, heat, pus, red streaks, or fever

    What to do Stop injecting and see a doctor the same day.

Do not use if

  • You are pregnant, trying to get pregnant, or breastfeeding (no safety data).
  • You are under 18 (no safety data in children or teens).
  • You have severe liver or kidney disease (how the body handles DSIP has not been studied).
  • You have had an allergic reaction to DSIP.
  • You have surgery coming up: DSIP made anaesthesia lighter and raised heart rate in a small study. Tell your surgical team you use it.
  • You are going through alcohol or opioid withdrawal. Get medical care; do not use DSIP to manage it on your own.

Sources3235

Sites and technique

Injecting

Belly Thigh

Under the skin (subcutaneous)

  • Belly, 2 inches from the navel
  • Front of the thigh

Use a new spot each night: the belly at least 2 inches (5 cm) from the belly button, or the front of the thigh. Skip skin that is tender, bruised, red, or scarred.

Storage

Keep it
Keep the mixed vial in the fridge (2-8 °C / 36-46 °F), away from light. Do not leave it at room temperature, and never leave it in a hot car. Do not use it if it turns cloudy or has specks in it.
How long
Use within 90 days of mixing. A mixed vial kept in the fridge holds its strength for 60-90 days, then slowly starts to lose potency. Wipe the rubber top with an alcohol swab before every draw.

Drawing your dose

051015202530 1.5

Draw to the 1.5 half-unit mark, the closest half-unit mark to the exact 1.3 units; it gives 112.5 mcg.

Syringe: a 0.3 mL (30-unit) U-100 insulin syringe with half-unit marks, so small doses are easy to read.

  1. Each unit line on a U-100 insulin syringe holds 75 mcg. For 250 mcg, draw to the 3.5-unit half mark (262.5 mcg). For the 100 mcg gentle start, draw to the 1.5-unit half mark (112.5 mcg). 300 mcg is exactly 4 units.
  2. Online guides may assume a different amount of water or a different vial size. Their unit numbers will not match this mix. Always go by the units on this page.
  3. Before every draw, hold the syringe at eye level, flick out air bubbles, and push the plunger back to the exact line.
  4. Pinch a fold of skin, insert the needle at 45 to 90 degrees, push slowly, and wait a few seconds before pulling out.
  5. Inject 30 to 60 minutes before bed, as the community does. In one 1980s IV study, sleep was promoted in the second hour after the dose, and the first hour could feel slightly more alert.
  6. If you wake up groggy, lower the dose. Do not drive or use machines while you still feel drowsy.
  7. Forgot a dose? Skip that night and take the next one at the usual time. Do not double up.
  8. Use a new sterile syringe every time and never share one.
Stacks and interactions

Pairs well with

  • The store pairs them in its Deep Sleep stack, and DSIP with CJC-1295/Ipamorelin is the most common DSIP stack in the community: DSIP for sleep quality, ipamorelin for growth-hormone release during deep sleep. In rats, the body's own DSIP appeared to drive the growth-hormone release that comes with deep sleep. The pair has not been tested together in people.3324

  • A less common community stack for people whose poor sleep comes with anxiety: DSIP for sleep, Selank for calm. In a Russian study of 62 people with anxiety disorder or nervous exhaustion, Selank eased anxiety about as well as medazepam, a benzodiazepine (a standard anti-anxiety drug). The pair has not been tested together.3330

  • A less common community stack aimed at sleep structure: DSIP for deep sleep, Epithalon for the pineal gland and melatonin, the hormone that sets your sleep timing. A review reports Epithalon directly affects melatonin production, mostly in lab and animal studies. The pair has not been tested together.3331

Interactions

  • Sleeping pills, benzodiazepines, other sedatives, and alcohol

    Not studied together. A community safety reference flags possible added drowsiness. In one case report, a woman came off a benzodiazepine sleeping pill during a week of hospital DSIP treatment, under close medical watch.

    What to do Avoid alcohol on dosing nights. Do not stop a prescribed sleeping pill on your own; ask your prescriber first.

  • Opioid pain medicines

    Researchers proposed that DSIP acts on the body's opioid system; in mice it reduced the withdrawal that naloxone (an opioid blocker) triggers. Effects alongside prescribed opioids in people are unknown.

    What to do Talk to your prescriber before combining. Do not use DSIP to manage withdrawal on your own.

  • Anaesthesia and surgery

    In a small study, IV DSIP made anaesthesia lighter and raised heart rate.

    What to do Tell your surgeon and anaesthetist that you use DSIP, and stop before surgery if they advise it.

  • Seizure medicines such as valproate

    In rats, DSIP strengthened valproate's anti-seizure effect. This has not been studied in people.

    What to do Ask your neurologist before using DSIP.

  • Steroid medicines (corticosteroids such as prednisone)

    DSIP affects the stress-hormone system in animal studies. A community safety reference flags corticosteroids as a possible interaction.

    What to do Ask your prescriber before combining, and never stop a steroid medicine suddenly on your own.

Sources

Key references

Sources

  1. 1Bes et al., Neuropsychobiology 1992: DSIP in 16 chronic insomnia patients (double-blind)Clinical trial
  2. 2Schneider-Helmert, Eur Neurol 1987: DSIP and 24-hour sleep-wake behaviour in severe chronic insomnia (14 people)Clinical trial
  3. 3Monti et al., Int J Clin Pharmacol Res 1987: short-term DSIP in chronic insomniaClinical trial
  4. 4Schneider-Helmert, Eur Neurol 1986: DSIP to normalize sleep in middle-aged and elderly insomniacs (18 people)Study
  5. 5Kaeser, Eur Neurol 1984: an open clinical trial with DSIP (7 patients)Study
  6. 6Schneider-Helmert, Eur Neurol 1984: DSIP in insomnia (summary of studies)Review
  7. 7Schneider-Helmert & Schoenenberger, Neuropsychobiology 1983: effects of DSIP in man (five human studies)Review
  8. 8Schneider-Helmert et al., Int J Clin Pharmacol Ther Toxicol 1981: DSIP in 6 healthy volunteersClinical trial
  9. 9Schneider-Helmert & Schoenenberger, Experientia 1981: DSIP in 6 chronic insomniacsStudy
  10. 10Dick et al., Eur Neurol 1984: DSIP in alcohol and opiate withdrawal (107 inpatients)Study
  11. 11Dick et al., Neuropsychobiology 1983: DSIP for withdrawal symptoms (67 patients)Study
  12. 12Larbig et al., Eur Neurol 1984: DSIP in chronic pain, a pilot study (7 patients)Study
  13. 13Schneider-Helmert, Eur Neurol 1984: effects of DSIP on narcolepsy (one patient)Study
  14. 14Schneider-Helmert et al., Dtsch Med Wochenschr 1987: DSIP for delayed-sleep-phase insomnia and benzodiazepine withdrawal (case report)Study
  15. 15Pomfrett et al., Eur J Anaesthesiol 2009: DSIP as an add-on to anaesthesia (24 women)Clinical trial
  16. 16Kovalzon & Strekalova, J Neurochem 2006: DSIP, a still unresolved riddle (review)Review
  17. 17Schoenenberger, Eur Neurol 1984: characterization, properties and functions of DSIP (review)Review
  18. 18Graf & Kastin, Neurosci Biobehav Rev 1984: DSIP reviewReview
  19. 19Graf et al., Peptides 1987: breakdown of DSIP in human and rat bloodStudy
  20. 20Banks et al., Pharmacol Biochem Behav 1982: DSIP crosses the blood-brain barrier in dogsStudy
  21. 21Zlokovic et al., Peptides 1989: DSIP transport into the guinea-pig brainStudy
  22. 22Umriukhin et al., Bull Exp Biol Med 2002: DSIP blocks glutamate excitation of rat brain neuronsStudy
  23. 23Graf et al., Neuroendocrinology 1985: DSIP reduces CRF-induced corticosterone release in ratsStudy
  24. 24Iyer et al., PNAS 1988: DSIP, slow-wave sleep, and sleep-related growth hormone release in ratsStudy
  25. 25Sahu et al., Life Sci 1987: DSIP stimulates LH release in ratsStudy
  26. 26Khvatova et al., Peptides 2003: DSIP and rat brain mitochondria under low oxygenStudy
  27. 27Scherschlicht et al., Eur Neurol 1984: pharmacological effects of DSIP in rabbits, cats, and miceStudy
  28. 28Hrncic et al., Pharmacology 2006: DSIP strengthens valproate against seizures in ratsStudy
  29. 29Tukhovskaya et al., Molecules 2021: DSIP and motor recovery after stroke in ratsStudy
  30. 30Zozulia et al., Zh Nevrol Psikhiatr 2008: Selank in generalized anxiety disorder and neurastheniaStudy
  31. 31Araj et al., Int J Mol Sci 2025: overview of Epitalon (review)Review
  32. 32FDA: Certain bulk drug substances for compounding that may present significant safety risks (emideltide / DSIP entry)Reference
  33. 33Peptide Protocol Wiki: DSIP community protocols (80 reports)Community
  34. 34Peptide Protocol Wiki: DSIP dosing and storageCommunity
  35. 35Peptide Protocol Wiki: DSIP side effects, contraindications, and interactionsCommunity

Where people discuss it

The FDA and Big Pharma

What “not FDA-approved” really means

Some peptides, like semaglutide (Ozempic and Wegovy), are FDA-approved medicines. Most of the peptides people research are not. That label sounds like the FDA tested something and turned it down. Usually it means something else: nobody has paid for the studies the FDA needs to see. Here is why.

The FDA doesn’t test drugs. Companies do.

The FDA does not run its own drug tests. A company that wants to sell a new medicine has to test it first, and pay for it. It studies the drug in animals, then in people: first 20 to 100 volunteers, then a few hundred, then up to 3,000. Then it sends all the results to the FDA. FDA scientists review them and decide whether the benefits outweigh the risks.

So approval always starts with a company asking for it. If no company applies, the FDA has nothing to review, however promising the research looks.

Those studies cost about a billion dollars

A study in the medical journal JAMA estimated that bringing one new drug to market costs a typical company about $1.1 billion. That figure includes the money spent on drug ideas that failed along the way, because many drugs that start human testing never make it.

A patent is how a company earns that money back

A patent is a right the government gives an inventor. For up to 20 years from the day the inventor applies, nobody else may make or sell the invention without permission.

For a drug company, that right is what makes the billion-dollar bet worth it. While the patent lasts, the company is the only seller, so it can charge enough to pay back the studies and the failures. When the patent runs out, other companies can sell cheap copies, called generics, and the price drops.

The FDA adds a shorter shield of its own. For 5 years after a brand-new drug is approved, no copycat version can apply for approval. That helps, but it is much shorter than a patent can last.

Why most peptides can’t be patented

To get a patent, an invention has to be new, and it has to be something people made, not something found in nature. Most popular peptides fail one test or both.

They come from nature. Many are copies or small pieces of molecules your body already makes. KPV is a 3-building-block piece of the hormone that tans your skin. BPC-157 is copied from a protein in stomach juice. In 2013 the US Supreme Court ruled that something that exists in nature, like a human gene, cannot be patented just because someone found it and pulled it out.

They aren’t new anymore. Many were first described in research papers decades ago. Scientists were already testing KPV in the 1980s. Once something has been published, it no longer counts as new, so nobody can patent it now, and any patents from back then have long since run out.

Without a patent, a company that paid for the studies would soon face rivals selling the same peptide without having paid for any research. Few companies will spend a billion dollars on a product anyone can copy. So nobody goes first, and the large human studies never happen.

The workaround: change the molecule

Drug companies do make peptide medicines, but they change the peptide first. A changed molecule is a new invention, so it can be patented. Semaglutide is a lab-made version of GLP-1, a gut hormone your body releases after meals, changed so one shot lasts a week. Tesamorelin (Egrifta) is the body’s own growth-hormone signal with a small fatty chain added. Both went through the full studies, and both are FDA-approved.

The natural versions, and the many peptides nobody has changed and patented, stay where they are: studied in labs and animals, used by the biohacking community, and never put through large human trials.

What this means for you

When a peptide is “not FDA-approved,” it usually means no company has paid for the large human studies. It does not mean the FDA tested it and found it harmful.

It also does not mean it is proven safe or proven to work. Without those studies, nobody knows the best dose for sure, or what rare or long-term side effects it may have. And the FDA does not check research peptides for purity or strength the way it checks approved medicines. That is why this page labels every finding by the kind of study behind it, and lists who should not use it.

Sources for this section

  1. 1FDA: How drugs are developed and approved (the FDA does not test drugs; companies submit the evidence)
  2. 2FDA: The drug development process, step 3: clinical research (study sizes for each phase)
  3. 3Wouters, McKee & Luyten, JAMA 2020, corrected 2022: median cost to bring a new drug to market, $1.14 billion
  4. 4US patent law, 35 U.S.C. § 154: a patent lasts 20 years from the filing date
  5. 5FDA: Frequently asked questions on patents and exclusivity (5-year new chemical entity exclusivity)
  6. 6US Supreme Court, Association for Molecular Pathology v. Myriad Genetics (2013): naturally occurring genes cannot be patented