Compounded peptide protocols are structured treatment programs built on peptides that a licensed compounding pharmacy can legally compound with a patient-specific prescription. In 2026, the clearly offerable Category 1 peptides include Sermorelin, PT-141, glutathione, and NAD+. This guide covers which protocols to offer, what each one requires, and what they return, for med spas, gyms, clinics, and entrepreneurs deciding where to start.
The Category 1 and Category 2 Landscape in 2026
The FDA sorts bulk drug substances into categories that decide what compounding pharmacies can legally prepare. Category 1 substances have enough supporting safety information on file that compounding is permitted while the FDA’s evaluation continues. Category 2 substances are still under evaluation and cannot be compounded. For a business owner, the practical question is: Category 1 is offerable today, Category 2 is not.
| Category 1: Offerable Now | Category 2: On Hold | |
|---|---|---|
| FDA status | Sufficient safety data on file; compounding permitted while review continues | Under evaluation; compounding not permitted |
| Legal to compound | Yes, with a valid patient-specific prescription | No, until the formal rule is finalized |
| Peptide examples | Sermorelin, PT-141, glutathione, NAD+ | BPC-157, TB-500, Selank, Semax, GHK-Cu, Epitalon |
| What it means for your business | Programs you can launch today | Monitor the rule; do not build programs yet |
The landscape shifted in February 2026, when HHS announced that roughly 14 Category 2 peptides, including BPC-157 and Thymosin Alpha-1, could return to Category 1 once the formal rule is finalized. The FDA’s Pharmacy Compounding Advisory Committee reviewed the proposed list on July 23-24, 2026, and returned a mixed recommendation: some substances were cleared for reclassification, others were kept under evaluation. The final status of each peptide is a one-by-one determination that lands when the FDA publishes the rule, which had not happened as of August 2026.
The demand side of this market is already large and growing. Grand View Research valued the global peptide therapeutics market at USD 140.86 billion in 2025 and projects it to reach USD 294.58 billion by 2033, a compound annual growth rate of 8.73 percent. That growth is one reason so many peptide compounds are moving toward the regulated prescription channel in the first place.
Demand for Category 2 compounds is real, but the legal door is not open. Building a program around a Category 2 peptide before the rule exists is the kind of exposure that gets businesses flagged by payment processors and advertising platforms. The disciplined move is to launch Category 1 protocols now, build the patient base, and add peptides when reclassification is final. Our FDA Category 1 peptides guide keeps the current compoundable list and the compliance requirements in one place, and our peptide therapy programs overview shows how a business runs these protocols end to end.
The Sermorelin Protocol: What a Clinic Program Looks Like
Sermorelin is the most established Category 1 peptide for clinic programs. The FDA approved it in 1997 for growth hormone deficiency in children, and the manufacturer ended commercial production in 2008 for business reasons rather than safety concerns. Instead of introducing growth hormone directly, Sermorelin signals the pituitary gland to produce and release it naturally, which is why patients describe results as gradual rather than dramatic. Patient interest is measurable: Google searches for “Sermorelin” increased more than 230 percent from August 2024 to August 2025, according to Google Ads Keyword Planner data.
The typical patient is an adult in their late 30s to 60s who wants more energy, better sleep, lean mass, and faster recovery. Longevity clinics, men’s health programs, and body-composition practices all run Sermorelin protocols, and the patients they attract are usually already paying for coaching, training, and supplements.
A standard clinic program runs 3 to 6 months with daily subcutaneous injections that patients self-administer at home. Programs are priced by dosing level, commonly 0.5 mg to 1 mg per day in clinic formularies, and the dose tier sets both the patient’s monthly price and the compounding pharmacy’s cost. Enrollment works through a patient signup with a health history, a provider review, and baseline labs before the first prescription. Most programs check in at 8 to 12 weeks to review response and side effects before renewing.
Compliance for a Sermorelin program rests on four things: a licensed Provider writes every prescription after reviewing the patient’s history, a licensed compounding pharmacy prepares the medication, the patient gives informed consent that the therapy is compounded, and follow-up is scheduled rather than assumed. You do not build the program’s clinical backbone. You bring the brand and the audience; the protocol design, provider review, compounding pharmacy, and monitoring are infrastructure. If you already offer weight loss or hormone programs, Sermorelin slots into the same signup and fulfillment flow as a second revenue line rather than a new operation.
The PT-141 Protocol: Sexual Wellness as a Program
PT-141, also known as bremelanotide, is the other Category 1 peptide worth building on, and it has a different commercial shape than Sermorelin. It is FDA approved under the brand name Vyleesi, approved in June 2019 for hypoactive sexual desire disorder in premenopausal women, and it is prescribed off-label for men and other patient groups. Where PDE5 inhibitors work on blood flow, PT-141 acts on melanocortin receptors in the central nervous system, which is why it can help patients who do not respond to sildenafil or tadalafil. The underlying need is large: sexual dysfunction affects an estimated 43 percent of women and 31 percent of men in the United States (Laumann et al., Journal of the American Medical Association).
The patient profile is distinct from the longevity crowd. These are women with low desire or arousal, men with situational erectile dysfunction or low libido, and couples who want on-demand support. Discretion matters more than anything else; these patients chose telehealth because they did not want a clinic waiting room, and they expect discreet packaging and quiet billing.
The program structure follows the medication’s on-demand nature. PT-141 is dosed as needed rather than on a daily cycle, so the protocol runs month to month instead of a fixed 3 to 6 month commitment. Monthly supplies are priced by dose count, commonly 4 to 8 doses, with refills tied to usage. The private-pay positioning keeps insurance billing and reimbursement disputes out of the operation.
Compliance runs on the same backbone as Sermorelin: provider review, a valid prescription, a licensed compounding pharmacy, and informed consent. What is different is marketing. Meta and Google restrict sexual wellness advertising, so patient acquisition leans on organic content, email, and influencer partnerships rather than direct paid media. Our guide to launching a PT-141 sexual wellness brand covers the positioning and the advertising constraints in detail, including the clinical-outcomes framing that keeps campaigns compliant.
The Glutathione and NAD+ Protocols: Longevity and Detoxification as Programs
Glutathione and NAD+ round out the offerable Category 1 set, and they behave differently from Sermorelin and PT-141 because both are established in longevity and wellness clinics with strong patient demand.
Glutathione is a tripeptide that functions as the body’s master antioxidant, and it is one of the most commonly compounded injectables in clinical practice. Programs use it for detoxification, immune support, skin brightening, and recovery, and the patient base overlaps heavily with the med spa and wellness crowd that already pays for IV therapy and aesthetic services. Glutathione programs run as scheduled injection cycles, commonly twice weekly for a loading phase followed by maintenance, and they price as a monthly program with dose-based tiers.
NAD+ is a coenzyme that declines with age and supports energy metabolism, DNA repair, and cellular signaling. It has become a cornerstone of longevity medicine, offered as IV infusions and subcutaneous maintenance injections. IV NAD+ sessions are among the highest-revenue services in the longevity space, and pairing in-clinic IV loading with home subcutaneous maintenance creates a dual revenue stream with strong patient retention. NAD+ programs require patient screening for conditions where the therapy is not appropriate, and the stimulatory effect means dosing starts low and titrates.
Both programs run on the same operational backbone as the other Category 1 protocols: a provider review, a valid prescription, a licensed compounding pharmacy, informed consent, and scheduled follow-up. The distinct advantage of glutathione and NAD+ is that patient demand is already proven in the wellness market, which shortens the education phase for a new program owner. Our peptide therapy programs overview shows how a business runs these protocols end to end, and the FDA Category 1 peptides guide keeps the current compoundable list current.
Building a Protocol Library Without Building It Yourself
A protocol library is the set of programs you offer plus the rules each one runs on: who is eligible, what consent is required, how patients are monitored, and when prescriptions renew. Owners who try to assemble this from scratch spend months on clinical infrastructure before their first patient. The real work is the operational rules around it: eligibility, consent, monitoring, and renewal.
Eligibility criteria are where a protocol earns its defensibility. Each program needs a health screening at signup, explicit disqualifiers, and lab requirements where the therapy calls for them. A PT-141 protocol, for example, needs screening for cardiovascular history that would rule out the medication. These criteria are what let a program accept or decline patients consistently rather than case by case.
Consent comes next. Every patient must give informed consent that the medication is compounded and, in most cases, used off-label, and that consent has to be collected and stored as part of the patient record. Monitoring is the third element: a scheduled follow-up cadence, a response check, and a clear path for side effects. Refill and renewal cadence completes the loop. For Sermorelin that means 3 to 6 month cycles with a review before renewal; for PT-141 it means monthly refills tied to usage. A renewal requires a new provider review before the next prescription is issued.
A platform carries this work directly. Pre-built Category 1 protocols carry the eligibility criteria, consent forms, monitoring schedule, and renewal logic, so the owner does not design them. The owner sets patient pricing and branding; the platform handles the signup flow, eligibility screening, provider review through its licensed Provider Network, compounding pharmacy routing, and renewal scheduling. Prescribing rules vary by state, and the telehealth peptide prescribing guide walks through what applies where. For businesses currently selling research-use-only peptides, the transition path is the same: the same audience, sold a prescribed Category 1 program instead of an unregulated vial.
Revenue Per Protocol: What Category 1 Programs Return
Both Category 1 programs are private-pay, so revenue is cash up front with no insurance claims. Sermorelin protocols typically sell for $199 to $299 per month, and PT-141 protocols for $149 to $249 per month. The owner’s margin is the spread between the patient price and the pass-through costs of medication and provider consults, and because protocols renew in cycles, that revenue is recurring. A PT-141 program at 100 active patients averaging $179 per month nets $7,000 to $11,000 per month after costs, and a Sermorelin program priced at $199 with $60 in per-patient costs leaves $139 in gross margin per patient per month.
The platform cost is a flat monthly platform fee with no per-patient fee, so adding patients improves margin without adding fixed cost. The compounding economics of each program are what make the numbers durable: a Sermorelin patient in month 4 is worth the same as a new one, with no acquisition cost attached. Growth compounds across programs too, since Sermorelin and PT-141 patients frequently enroll in the same clinic.
One caveat applies to this math: it applies to what is legal today. Revenue projections built on Category 2 peptides come with a risk no spreadsheet captures, because the program cannot start until the FDA finalizes the rule, and inventory bought before then has nowhere to go.
Which Protocol to Offer First
The Category 1 programs described here are offerable today, the demand is measurable, and the infrastructure to run them can be in place within days rather than months. If you are deciding which peptide programs to offer, Sermorelin is the safer anchor for a longevity or performance audience, glutathione and NAD+ capture the wellness crowd that already pays for IV therapy, and PT-141 is the higher-margin add-on with a distinctly different patient base. Many owners launch one protocol first and add the others once the signup flow is proven. Book a call with Karpa Health to talk through which protocols fit your business and your market.
