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PEPLUX

Emideltide, also called DSIP

DSIP Injection

Also called DSIP, Delta sleep-inducing peptide.

Illustrative PEPLUX product vial in a purple-lit studio
Product illustration

Product form

Subcutaneous injection

The process

Licensed provider review

DSIP Injection cost

$229 per month

*If medically eligible.
Medication
Included
Clinician visit
Included
Baseline labs
Included
Lab retests
Included when ordered by your provider
Shipping
Included
Patient portal access
Included
Care-team chat support
Included

Considering more than one product?

  • Two products prescribed together: $349 per month
  • Three products prescribed together: $479 per month
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Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

FDA status, checked on October 13, 2026

DSIP Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Order now

No compounding pathway today.

*If medically eligible.

Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.

Prescription products require an online evaluation with a licensed provider. Not all patients qualify.

States served: not yet confirmed. How state availability works

What is DSIP Injection?

Emideltide, also called delta sleep-inducing peptide or DSIP. The dispensing pharmacy must document its identity and formulation before ordering is enabled.

Adults seeking a provider discussion about emideltide after reviewing its evidence limitations and risks. Its common name does not establish an effect on sleep or any other clinical outcome.

Key risks

  • Safety in people has not been established. Side effects and longer-term risks of emideltide are not adequately characterized.
  • Immune reactions to the peptide or impurities are a concern, and limited safety information makes the frequency of adverse effects uncertain.
All risks and who should not use it

FDA status

FDA status for DSIP Injection.

Rendered from our regulatory records, which cite FDA, Federal Register and label documents directly. Each record shows the date we last checked it.

No compounding pathway today.

DSIP Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

DSIP Injection

No compounding pathway today.

FDA’s documents list it as Emideltide (DSIP).

Emideltide (DSIP) is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 in April 2026 after the nominations were withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee did not recommend it on July 24, 2026, and nothing favorable is pending.

Basis
FDA's 503A categories document of April 15, 2026 announced the removal of emideltide from Category 2, effective seven days later, because its nominations were withdrawn. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page says compounded emideltide may pose a risk of immunogenicity and that FDA has not identified safety-related information for the proposed route of administration.
Checked on
October 13, 2026

How it works

DSIP Injection mechanism.

DSIP is another name for emideltide. The product name alone does not explain how a formulation behaves in people or establish a treatment mechanism. Ingredient identity and formulation require confirmation before any treatment decision.

That describes what the molecule does in the body. It is not a claim about what it will do for you.

What the evidence supports

DSIP Injection: evidence and limitations.

The available safety information for emideltide is limited. PEPLUX has not verified clinical evidence that establishes this formulation as safe and effective for a clinical use. The name DSIP should not be interpreted as proof of a sleep benefit.

Risks

DSIP Injection risks and side effects.

  • Safety in people has not been established. Side effects and longer-term risks of emideltide are not adequately characterized.
  • Immune reactions to the peptide or impurities are a concern, and limited safety information makes the frequency of adverse effects uncertain.
  • Injection can cause pain, redness, swelling or bruising. Infection is possible if the product or injection technique is not sterile.
  • Safety information is insufficient for use during pregnancy or breastfeeding or in people under 18. These groups should not use this product.
  • Seek urgent medical care for trouble breathing, swelling of the face or throat, or other signs of a serious allergic reaction.

This information is educational and is not medical advice. It does not establish a provider–patient relationship.

Clinical review

What your prescriber will consider.

These are decision factors a licensed provider weighs when deciding whether this product is appropriate for you. They are not instructions, and there is no dosing protocol on this page.

  • The reason for seeking treatment, existing medical evaluation and whether an established treatment should come first

  • All medicines and supplements, including sedating products and medicines acting on the nervous system

  • Any prior allergic or immune reaction and the limited information about interactions and long-term use

  • Pregnancy, breastfeeding, plans to conceive and any applicable anti-doping rules

PEPLUX does not publish self-administration protocols. Dose, frequency and duration are set by your prescriber against your own history and reviewed over time.

Lot documents

What a certificate of analysis should cover.

When a pharmacy is named, each lot's certificate of analysis is expected to cover the tests below. No certificate exists or is published yet.

  • Potency
  • Sterility
  • Endotoxin
  • pH

Sport and anti-doping

WADA status.

  • Not named on the WADA 2026 Prohibited List. Not named on the 2026 list. Whether the S0 class (substances with no government approval for human therapeutic use) reaches it has not been confirmed.

The list is revised every year. If you compete, check the current list and your federation’s own rules.

Straight answers

Common questions about DSIP Injection.

What is the FDA status of DSIP Injection?
No compounding pathway today. Emideltide (DSIP) is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 in April 2026 after the nominations were withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee did not recommend it on July 24, 2026, and nothing favorable is pending. Checked against primary sources on October 13, 2026.
Is compounded DSIP Injection an approved drug?
No. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. DSIP Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established. PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.
What does the evidence support for DSIP Injection, and what does it not?
The available safety information for emideltide is limited. PEPLUX has not verified clinical evidence that establishes this formulation as safe and effective for a clinical use. The name DSIP should not be interpreted as proof of a sleep benefit.
What are the risks of DSIP Injection?
Safety in people has not been established. Side effects and longer-term risks of emideltide are not adequately characterized. The full list of side effects, and of who should not use DSIP Injection, is in the risks section of this page. Your prescriber reviews your history before deciding whether it is appropriate for you.
Does DSIP Injection require baseline labs?
Your prescriber determines whether baseline labs are needed before considering DSIP Injection. Baseline labs are included in the price.
What does DSIP Injection cost?
$229 per month. Medication: included. Clinician visit: included. Baseline labs: included. Lab retests: included when ordered by your provider. Shipping: included. Patient portal access: included. Care-team chat support: included. *If medically eligible.
Is DSIP Injection prohibited in sport?
Not named on the WADA 2026 Prohibited List. Not named on the 2026 list. Whether the S0 class (substances with no government approval for human therapeutic use) reaches it has not been confirmed.
How is DSIP Injection given?
Subcutaneous injection. Your prescriber decides whether it is appropriate for you and sets the regimen. PEPLUX does not publish dosing.

Next step

A licensed provider reviews every request.

DSIP Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Order now

No compounding pathway today.

*If medically eligible.

Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

Also offered

Other products.

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