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An independent overview of the compounded-GLP-1 telehealth market and the providers we cover — market size, what the FDA changed, and an honest read on each.

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§ Category · 01

Weight loss and metabolic peptides — GLP-1 and beyond

GLP-1 and dual-agonist drugs for weight loss and metabolic disease — what the FDA has approved, what trials have shown, and the honest version of what each compound does. Includes semaglutide, tirzepatide, liraglutide, and the broader GLP-1 class.

For three years, weight loss has been the category that ate the rest of telehealth. GLP-1 drugs reshaped what cash-pay medical brands sell, how compounding pharmacies operate, and how venture money flows. In mid-2026 the rules are clearer than they were even a year ago — and the next wave is arriving faster than most patients realize. Two oral GLP-1 drugs for obesity are now FDA-approved and on US pharmacy shelves. The compounded supply that powered the boom is being squeezed on both ends by the FDA, with a final comment deadline closing in late June. Beyond the GLP-1 class, tesamorelin (a GHRH analog approved for HIV-associated lipodystrophy) has been the only other FDA-approved body-composition peptide in the field for years; AOD-9604 and a handful of growth-hormone-axis compounds remain at the research edge. This page is the honest field-level read on all of it.

§ 01 / What is actually approved, what is compounded, what is research-only

What is actually approved, what is compounded, what is research-only

The single most useful frame for this category, in mid-2026, is the regulatory one. The drugs people talk about as if they were interchangeable have very different legal lives.

FDA-approved and on US pharmacy shelves. Most of the compounds in this category have approved drug labels in Drugs@FDA [1]. Semaglutide is approved as Ozempic (subcutaneous, NDA 209637) for type 2 diabetes, as Wegovy for chronic weight management, and as Rybelsus (oral) for type 2 diabetes; Novo's oral Wegovy pill, launched in 2026, is the obesity-indicated oral semaglutide formulation. Tirzepatide is approved as Mounjaro (NDA 215866) for type 2 diabetes and Zepbound (NDA 217806) for chronic weight management. Liraglutide, the first-generation drug in the class, is now off-patent and exists as the originator product plus at least two ANDA generics from Lupin and Biocon. Tesamorelin is the GHRH analog approved as EGRIFTA SV (BLA 022505, Theratechnologies) — but only for HIV-associated lipodystrophy, not general weight management. Foundayo, Eli Lilly's orforglipron tablet, was approved by FDA on April 1, 2026 and launched in US pharmacies on April 9 [2]. It is the first oral small-molecule GLP-1 receptor agonist — distinct from oral semaglutide because it doesn't require the strict fasting and water-intake restrictions that the Wegovy pill carries.

Compounded, not approved. Compounded versions of semaglutide and tirzepatide drove most of the telehealth weight-loss market between 2022 and 2025. The doorway that allowed that was the FDA shortage exemption. Both drugs were on the FDA Drug Shortages list in 2023 and most of 2024. Tirzepatide came off the list on December 19, 2024; semaglutide in March 2025. Once a drug is off the shortage list, the "essentially a copy" prohibition reasserts and large-volume compounding becomes much harder to justify under either Section 503A or Section 503B. The architecture is detailed in our compounded vs branded peptides explainer — short version, the supply pathway most telehealth providers used is now closed for these molecules unless an outsourcing facility is operating under a narrow patient-specific exemption or unless the bulks-list rulemaking we cover below somehow flips.

Research-only or narrow-use. AOD-9604 is a fragment of human growth hormone that has been studied for fat reduction; it is not approved as a drug for weight loss in the US and the human evidence base is thin. It is most often sold as a research compound or compounded from a 503A pharmacy on physician request. The category overlaps the growth-hormone-secretagogue cluster (CJC-1295, Ipamorelin, Sermorelin), which has its own canonical home under performance and longevity — see the cross-cutting rail at the foot of this page.

§ 02 / Two FDA actions converging in late June

Two FDA actions converging in late June

The FDA is closing both the supply door and the marketing door on compounded GLP-1s in the same month, and patients on compounded products should understand the timing.

The supply side. On April 30, 2026, FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list — the list of bulk drug substances that outsourcing facilities are allowed to compound from [3]. The agency wrote that it "did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances." Public comments are open until June 29, 2026. After that the agency will weigh the docket and issue a final determination. If finalized, the proposal closes the main remaining legal pathway for 503B outsourcing facilities to make these drugs from active pharmaceutical ingredient.

The marketing side. Two months later, on June 8, 2026, FDA's Office of Compounding Quality and Compliance issued a batch of warning letters to telehealth companies marketing compounded GLP-1s with false or misleading claims. At least eight letters in that batch went to telehealth platforms, including Maximus — a provider we review. The four claim patterns FDA flagged in the batch — implying FDA approval, calling the source pharmacy "FDA-approved," equating the compound to the branded drug, and putting the telehealth brand's name on the vial — are the marketing copy that built the category. Each named company has fifteen business days from receipt to respond, which puts the response deadline around the end of June as well.

Both threads point the same direction. The window for cheap compounded GLP-1s, which was already narrowing, is narrowing further. The FDA-approved alternatives are scaling fast enough to take the demand.

§ 03 / What the trials actually show

What the trials actually show

The evidence base is now mature enough that the case-control comparisons matter more than the individual trial headlines. Three threads are worth knowing.

Semaglutide as the baseline. STEP 1 reported about 15% mean body-weight loss at 68 weeks with weekly subcutaneous semaglutide 2.4 mg versus about 2.5% with placebo, in adults with overweight or obesity without diabetes [4]. STEP 3, STEP 4, and STEP 8 followed with variations on lifestyle support, withdrawal maintenance, and a head-to-head against liraglutide [5]. The pattern is consistent. The withdrawal data — the STEP 1 trial extension — showed that participants regained about two-thirds of lost body weight within a year of stopping the drug [6]. That is the trial readout that should anchor any expectation a patient has about long-term outcomes: GLP-1 weight loss is a maintenance therapy, not a course.

Tirzepatide as the higher-ceiling alternative. SURMOUNT-1 reported about 20% mean body-weight loss at 72 weeks at the highest dose — measurably higher than semaglutide's number, in a similar population [7]. A head-to-head observational comparison published in JAMA Internal Medicine in 2024 reproduced the gap in real-world EHR data [8]. SURMOUNT-4 (maintenance), SURMOUNT-CN (Chinese cohort), and the SUMMIT trial for heart failure with preserved ejection fraction extend the data into specific populations [9]. A separate NEJM trial in 2024 reported tirzepatide's effect on obstructive sleep apnea in adults with obesity [10]. The point is not that tirzepatide is universally better — it is more effective on average, with a similar side-effect profile, often at higher cost and more variable insurance coverage.

The 2025 systematic review. The Annals of Internal Medicine published a systematic review of GLP-1 receptor agonists in adults without diabetes that aggregated the available RCTs and concluded the efficacy and safety profile for chronic weight management is now established, with the caveats this page documents below [11]. It is the cleanest single citation when a reader asks "what do the trials actually say overall."

§ 04 / The pipeline that is changing the landscape now

The pipeline that is changing the landscape now

Eight months from now this section will look different. The drugs and trials in the field as of mid-2026:

Oral GLP-1s, scaled. Novo Nordisk launched its Wegovy pill (oral semaglutide reformulated for chronic weight management) in the US in January 2026. The company reported on June 7, 2026 that the drug crossed three million US prescriptions in its first five months — "one of the strongest US pharmaceutical launches by volume on record," in its own framing [12]. Eli Lilly's Foundayo (orforglipron) launched on April 9, 2026, into a market Novo had a three-month head start in. Foundayo's distinguishing feature is that it is a small molecule rather than a peptide — that lets Lilly skip the dietary restrictions Novo has to carry on the Wegovy pill label. Lilly says ACHIEVE-4 safety data supports a planned type 2 diabetes indication filing later this year [2].

Duals, triples, and the next-generation entrants. Boehringer Ingelheim and Zealand's survodutide (GLP-1 / glucagon dual agonist) read out a 16.6% weight-loss number in phase 3 in late April 2026 [13]. Eli Lilly's retatrutide (GLP-1 / GIP / glucagon triple agonist) and Novo Nordisk's CagriSema (semaglutide plus cagrilintide) are both in late-stage trials. Smaller entrants — Structure Therapeutics, BrightGene, and ecnoglutide (cleared in China for weight loss in March 2026) — are filling specific niches. The competitive structure of this market is changing fast enough that any "best provider" or "best drug" call has a shelf life of months, not years.

What the pipeline does not change. The class-level mechanism (GLP-1 receptor agonism, plus or minus GIP, glucagon, or amylin co-agonism) is the same one the original drugs use. Side-effect profile, weight-regain pattern after discontinuation, and the maintenance-therapy framing are all carried over. A patient who could not tolerate semaglutide because of nausea is unlikely to tolerate the next dual agonist, either.

§ 05 / Safety signals worth understanding

Safety signals worth understanding

The literature has matured enough to name the signals that should be on a prescribing physician's checklist. None of these is a reason to avoid the class — but each is a reason to discuss before starting, and each has shaped what an honest review of any GLP-1 provider should say.

Gastrointestinal. Nausea, vomiting, and constipation are common across the class. They are usually dose-related and improve with slow titration. A 2024 Lancet Gastroenterology & Hepatology review covers the mechanism and the management in detail [14].

Gallbladder and biliary disease. A 2022 JAMA Internal Medicine meta-analysis reported elevated risk for gallbladder and biliary disease with GLP-1 receptor agonist use compared with placebo or active comparators [15]. Absolute risk is small; the effect is consistent enough to warrant counseling, especially for patients with prior gallbladder pathology.

Thyroid carcinogenic risk. The drug labels carry a boxed warning for medullary thyroid carcinoma based on rodent data. The 2024 IJMS systematic review concluded the human signal is unproven but unresolved, and the contraindication for patients with personal or family history of medullary thyroid cancer or MEN-2 syndrome remains in the label [16].

NAION (non-arteritic anterior ischaemic optic neuropathy). A 2025 Acta Ophthalmologica review and several case-series papers describe an association between semaglutide use and NAION, a rare eye condition that can cause sudden vision loss [17]. The association is not yet causal but has prompted ophthalmology professional bodies to add it to differential diagnoses in patients on semaglutide.

Muscle mass and body composition. Roughly a quarter to a third of weight lost on GLP-1 therapy comes from lean tissue rather than fat, depending on the trial and the population. A 2024 Circulation editorial frames the question — adaptive or maladaptive — and points at resistance training and adequate protein as the two evidence-supported countermeasures [18]. Pharmaceutical sponsors (Lilly, Regeneron, others) are running trials of activin-pathway inhibitors as adjunct therapies; none has approval yet.

§ 06 / Where to buy, and what an honest provider says

Where to buy, and what an honest provider says

All seven of the telehealth providers PeptideWellness covers in our reviews sell GLP-1 weight-loss programs in some form — compounded, branded, or both. The lineup as of June 2026: Henry Meds, Hims, Maximus, Mochi Health, Ro, TeleZenMD, and TrimRx. The provider overview page is the directory; each review carries our honest read on pricing, pharmacy partner, prescriber transparency, and where we'd be cautious.

What to ask a provider, regardless of which one: which entity actually compounds the product they ship, and under which legal pathway (503A patient-specific, or 503B outsourcing-facility); whether the molecule is the base form or a salt; whether the provider is currently on FDA's warning-letter list; and what happens to your prescription if the 503B bulks-list exclusion finalizes after the June 29 comment close. Our news coverage of the June 2026 enforcement wave details the four claim patterns FDA flagged and the legal framework behind them.

§ 07 / Frequently asked

Frequently asked

Is compounded semaglutide the same as Wegovy?

Chemically, the base form of semaglutide in a properly sourced compounded preparation is the same active molecule as in Wegovy. The regulatory and quality apparatus around the molecule is not the same. A branded manufacturer makes the drug under CGMP in a process FDA reviewed, with each lot tested to specifications FDA reviewed. A compounded preparation made by a 503A pharmacy with intermittent state inspections is not subject to those same checks. FDA's stance, articulated in the June 2026 warning letters, is that marketing copy that elides this distinction is misleading.

Is oral semaglutide (Wegovy pill, Rybelsus) as effective as the injection?

Roughly comparable for many patients, with some caveats. The pill has strict dosing instructions — empty stomach, with a small amount of water, then 30 minutes before food — because bioavailability is heavily affected by anything else in the stomach. Patients who can keep that protocol tend to do well; patients who can't may see lower exposure. Foundayo (Lilly's oral) does not have the same restrictions because it is a small molecule rather than a peptide.

What happens to weight after stopping a GLP-1?

On average, about two-thirds of lost body weight returns within a year of discontinuation, per the STEP 1 extension data [6]. The class is best understood as a maintenance therapy. Tapering and continuation strategies are an active area of research; there is no established protocol for stopping permanently without weight regain.

Does tirzepatide work better than semaglutide?

On average, yes, in head-to-head meta-analysis (about 20% versus 15% mean weight loss in the SURMOUNT-1 / STEP 1 comparable populations) [8]. Individual response varies. Cost and insurance coverage differ. Both have similar side-effect profiles. The right answer for a given patient depends on prior tolerance, coverage, and what they are optimizing for.

Is the compounded GLP-1 supply going away?

The supply pathway most telehealth providers used (503B outsourcing facilities compounding from bulk under the shortage exemption) is already closed for these molecules. The narrower 503A patient-specific pathway remains, but it does not support the volumes that built the cash-pay market. If FDA finalizes the bulks-list exclusion after the June 29 comment close [3], the 503B doorway closes definitively. The branded FDA-approved alternatives — Wegovy, Zepbound, Foundayo, Mounjaro, Ozempic, Rybelsus, Saxenda — are the legal supply path for ongoing therapy.

§ 08 / References

References

  1. FDA — Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
  2. Lilly says Foundayo safety confirmed in ACHIEVE-4 trial. Pharmaphorum, April 16, 2026. https://pharmaphorum.com/news/lilly-says-foundayo-safety-confirmed-achieve-4-trial
  3. FDA — Press release: "FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List," April 30, 2026. https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
  4. Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384:989-1002. PMID 33567185. https://pubmed.ncbi.nlm.nih.gov/33567185/
  5. Rubino DM, Greenway FL, Khalid U, et al. Effect of weekly subcutaneous semaglutide vs daily liraglutide on body weight in adults with overweight or obesity without diabetes: the STEP 8 randomized clinical trial. JAMA. 2022;327:138-150. PMID 35015037. https://pubmed.ncbi.nlm.nih.gov/35015037/
  6. Wilding JPH, Batterham RL, Davies M, et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: the STEP 1 trial extension. Diabetes Obes Metab. 2022;24:1553-1564. PMID 35441470. https://pubmed.ncbi.nlm.nih.gov/35441470/
  7. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387:205-216. PMID 35658024. https://pubmed.ncbi.nlm.nih.gov/35658024/
  8. Semaglutide vs tirzepatide for weight loss in adults with overweight or obesity. JAMA Intern Med. 2024. PMID 38976257. https://pubmed.ncbi.nlm.nih.gov/38976257/
  9. Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity (SUMMIT). N Engl J Med. 2025. PMID 39555826. https://pubmed.ncbi.nlm.nih.gov/39555826/
  10. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. N Engl J Med. 2024. PMID 38912654. https://pubmed.ncbi.nlm.nih.gov/38912654/
  11. Efficacy and safety of GLP-1 receptor agonists for weight loss among adults without diabetes: a systematic review of RCTs. Ann Intern Med. 2025. PMID 39761578. https://pubmed.ncbi.nlm.nih.gov/39761578/
  12. Novo Nordisk — Press release: "Wegovy® pill prescriptions surpass 3 million...," June 7, 2026. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916566
  13. Boehringer/Zealand dual-acting drug causes 16.6% weight loss. Pharmaphorum, April 28, 2026. https://pharmaphorum.com/news/boehringerzealand-dual-acting-drug-causes-166-weight-loss
  14. Gastrointestinal effects of GLP-1 receptor agonists: mechanisms, management, and future directions. Lancet Gastroenterol Hepatol. 2024. PMID 39096914. https://pubmed.ncbi.nlm.nih.gov/39096914/
  15. He L, Wang J, Ping F, et al. Association of GLP-1 receptor agonist use with risk of gallbladder and biliary diseases: a systematic review and meta-analysis of RCTs. JAMA Intern Med. 2022;182:513-519. PMID 35344001. https://pubmed.ncbi.nlm.nih.gov/35344001/
  16. Assessment of Thyroid Carcinogenic Risk and Safety Profile of GLP1-RA Semaglutide (Ozempic) Therapy for Diabetes Mellitus and Obesity: A Systematic Literature Review. Int J Mol Sci. 2024. PMID 38673931. https://pubmed.ncbi.nlm.nih.gov/38673931/
  17. Semaglutide and non-arteritic anterior ischaemic optic neuropathy: review and interpretation of reported association. Acta Ophthalmol. 2025. PMID 40055951. https://pubmed.ncbi.nlm.nih.gov/40055951/
  18. Muscle Mass and GLP-1 Receptor Agonists: Adaptive or Maladaptive Response to Weight Loss? Circulation. 2024. PMID 39401279. https://pubmed.ncbi.nlm.nih.gov/39401279/

Editorial note: Informational only — not medical advice. Decisions about GLP-1 therapy — compounded, branded, oral, or injectable — should be made with a licensed healthcare provider familiar with your medical history. Last reviewed June 2026.

§ The compounds in this category

What we cover under weight loss.

§ The drug class itself

About the GLP-1 class itself.

GLP-1 receptor agonists are peptides (and, increasingly, small molecules) that mimic glucagon-like peptide-1, an incretin hormone that drives glucose-dependent insulin secretion, slows gastric emptying, and signals satiety in the hypothalamus. We treat each approved or compounded drug in its own page; the class itself — biology, chronology, the pipeline (orforglipron, retatrutide, MariTide, CagriSema), and the hard definitional lines — lives in a dedicated explainer.

Read the GLP-1 class field guide
§ Cross-cutting peptides

Cross-cutting peptides.

Some peptides have more than one goal. Their canonical home stays where the primary use sits — but they surface here too, tagged for the secondary read.

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