Dihexa: where it stands with the FDA, and what it costs
No FDA-approved drug contains it, and the FDA says it has found no data on its use in people.
Go to clinicLowest per monthDihexa capsules
EllieMD · ≈ $164/mo ($458 for 84 days)
Go to clinicLowest at a clinic we link toDihexa injection
Pepti · $219/mo (≈ $235 per 30 days with its fees)
Where Dihexa stands today
No FDA-approved drug contains dihexa. FDA placed dihexa acetate in 503A Category 2 (significant safety risks) on September 29, 2023, saying it had found no human exposure data for any route, and removed it on April 22, 2026 because the nomination was withdrawn. FDA plans an advisory committee review of dihexa acetate before the end of February 2027. It is not on the 503A or 503B bulks list, is in no category, and is not in HHS's October 2026 interim policy.
For pharmacies compounding one patient's prescription (section 503A)
Not in any 503A category and not on the 503A bulks list. Removed from Category 2 on April 22, 2026 (nomination withdrawn); advisory committee review planned before the end of February 2027. Not in HHS's Oct 2026 interim policy.
“Bulk drug substances nominated but withdrawn ... Dihexa acetate FDA has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration. FDA lacks important information regarding any safety issues raised by dihexa acetate, including whether it would cause harm if administered to humans.”
Placed in 503A Category 2 on September 29, 2023
“Dihexa acetate 503A September 29, 2023”
““Dihexa Acetate” has been removed from category 2 because the nomination was withdrawn by the nominator. However, FDA has announced it intends to consult the PCAC before the end of February 2027 regarding the potential inclusion of Dihexa acetate on the 503A bulks list.”
HHS's list of six does not include dihexa
“Appendix A. List of Peptide Bulk Drug Substances Addressed by HHS Interim Enforcement Policy Regarding 503A Compounding 1. BPC-157 2. Epitalon 3. KPV 4. MOTS-c 5. Semax 6. TB-500”
FDA interim 503A bulks policy: a substance outside Category 1 gets no interim enforcement discretion
“Drug products compounded using a bulk drug substance for which each of the above circumstances are not present are not within the scope of the policy described in this guidance.”
For outsourcing facilities (section 503B)
Not on the 503B bulks list and not in any 503B category (FDA's 503B nominations list, updated March 21, 2025, does not name it)
“Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or”
The 503B bulks list holds five substances (diphenylcyclopropenone, glycolic acid, quinacrine HCl oral, squaric acid dibutyl ester, trichloroacetic acid); none of the compounds in this file
“FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:”
The FDA's compounding advisory committee
Invalid Date: Whether to include dihexa acetate on the 503A bulks list. Pending
“FDA will host an advisory committee meeting before the end of February 2027 ... The Committee will discuss the following bulk drug substances being considered for inclusion on the 503A bulks list: Cathelicidin (LL-37) GHK-Cu Dihexa acetate”
Our reading
There is no current route to lawful 503A or 503B compounding of dihexa; that could change only after the planned committee meeting and an FDA or HHS decision.
Every source above was checked again on 14 November 2026.
What 5 clinics charge
- EllieMDDihexa capsules≈ $164/mo$458 for 84 days
- Bowery ClinicDihexa capsules (10mg)$199for 30 days
- PeptiDihexa injection$219/mo≈ $235 per 30 days with its fees
What Dihexa is
- What it is
- Angiotensin IV analog (small peptide-derived molecule)
- How it works
- A small molecule built from part of angiotensin IV and studied in animals for memory; it acts on the hepatocyte growth factor (HGF/c-Met) system.
- How it is given
- Oral capsules; also sold as injections
- Also called
- dihexa acetate
Dihexa side by side
About Dihexa
Is Dihexa FDA-approved?
No. No FDA-approved drug contains Dihexa. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is Dihexa legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug contains dihexa. FDA placed dihexa acetate in 503A Category 2 (significant safety risks) on September 29, 2023, saying it had found no human exposure data for any route, and removed it on April 22, 2026 because the nomination was withdrawn. FDA plans an advisory committee review of dihexa acetate before the end of February 2027. It is not on the 503A or 503B bulks list, is in no category, and is not in HHS's October 2026 interim policy.
How much does Dihexa cost?
5 clinics publish a price. The lowest that compares per month is about $164 a month ($458 for 84 days) at EllieMD, and the middle of 3 clinics' lowest monthly prices is about $199. What a month buys differs by clinic, so each price lists what it includes. every Dihexa price
What forms does Dihexa come in?
Clinics sell it as capsules (4 prices), injection (1 price).