GLP-1 TirzepatideRx

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Source Ledger

Every primary source this site rests on, with a live link, what it supports, and the date we read it. Plus the claims we deliberately do not source, and why.

Short answer

This page lists every primary source behind the clinical, regulatory and safety statements on this site: 15 regulator documents, labeling records and trial reports, each with a working link and a plain description of which claims rest on it. Every trial in our library also links to its own ClinicalTrials.gov record and DOI.

The second table is the one most publishers omit: the claims we cannot source, stated openly rather than dressed up with a citation that does not actually support them.

Primary sources

Read on 2026-08-05. Links open on the publisher's own site — we do not mirror or paraphrase a source in place of linking it. If one of these has rotted, tell us and it goes in the corrections log rather than being quietly replaced.

Primary source ledger — 15 records, accessed 2026-08-05.
SourceTypeWhat it supports here Accessed
ZEPBOUND (tirzepatide) injection — full prescribing information
DailyMed, US National Library of Medicine
Regulatory labelingThe dose ladder (2.5 mg initiation for four weeks, 2.5 mg increments at intervals of at least four weeks, 15 mg maximum), the statement that 2.5 mg is not approved as a maintenance dosage, injection sites and rotation, storage, contraindications (MTC and MEN 2, serious hypersensitivity), the boxed warning on rodent thyroid C-cell tumours, and the warnings on severe gastrointestinal reactions, acute kidney injury from volume depletion, gallbladder disease and pancreatitis.2026-08-05
ZEPBOUND highlights of prescribing information (2026 revision, PDF)
US Food and Drug Administration, Drugs@FDA
Regulatory labelingThe current approved label including the dosing schedule applying to all approved indications, and the note that routine calcitonin monitoring or thyroid ultrasound is of uncertain value for early MTC detection.2026-08-05
FD&C Act provisions that apply to human drug compounding
US Food and Drug Administration
Regulatory frameworkThe distinction between section 503A compounding by a licensed pharmacist in a state-licensed pharmacy and section 503B compounding within an FDA-registered outsourcing facility, and the different requirements attaching to each.2026-08-05
Pharmacy compounding of human drug products under section 503A — final guidance
US Food and Drug Administration
Regulatory guidanceThe conditions under which a compounded drug is exempt from new drug approval, current good manufacturing practice and adequate-directions-for-use requirements — that is, why a compounded preparation is lawful without being FDA-approved.2026-08-05
Registration for human drug compounding outsourcing facilities under section 503B
US Food and Drug Administration
Regulatory guidanceWhat registration as an outsourcing facility involves, used on our 503A versus 503B page.2026-08-05
FDA's concerns with unapproved GLP-1 drugs used for weight loss
US Food and Drug Administration
Safety communicationThat compounded drugs should only be used where an FDA-approved drug cannot meet the patient's need and should be filled at a state-licensed pharmacy; FDA's import alert on GLP-1 active pharmaceutical ingredient from certain manufacturers; enforcement touching telehealth marketing of retatrutide and API distributors selling it; the existence of fraudulent compounded semaglutide and tirzepatide carrying false product information; and complaints that compounded GLP-1 shipments arrived warm or with inadequate ice packs.2026-08-05
FDA warns 30 telehealth companies against illegal marketing of compounded GLP-1s
US Food and Drug Administration (press announcement)
EnforcementThat 30 warning letters were issued to telehealth companies for false or misleading claims; that the primary violations were claims implying sameness with FDA-approved products and obscuring product sourcing by branding a compounded product with the telehealth firm's own name; and FDA's statement that compounded drugs are not FDA-approved, are not reviewed for safety, effectiveness or quality before marketing, and are not the same as generic drugs.2026-08-05
FDA intends to take action against non-FDA-approved GLP-1 drugs
US Food and Drug Administration (commissioner's statement)
EnforcementFDA's stated intent to restrict GLP-1 active pharmaceutical ingredients used in non-approved compounded drugs that are mass-marketed as alternatives to approved products, and its position that promotional materials may not claim compounded products are generic versions of, the same as, or clinically proven equivalent to FDA-approved drugs.2026-08-05
FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
US Food and Drug Administration
Supply statusThat FDA determined the tirzepatide injection shortage resolved on 2 October 2024, and the reminder of legal restrictions on compounding copies of FDA-approved drugs — the regulatory hinge behind the restructuring of the compounded market.2026-08-05
Tirzepatide once weekly for the treatment of obesity (SURMOUNT-1)
New England Journal of Medicine 2022;387:205-216
Randomized controlled trialThe headline weight-reduction figures at 72 weeks across the 5, 10 and 15 mg arms against placebo, and the adverse-event frequencies quoted throughout the side-effect cluster.2026-08-05
SURMOUNT-1 — PubMed record (PMID 35658024)
PubMed, US National Library of Medicine
Bibliographic recordAbstract and citation metadata for SURMOUNT-1, for readers without journal access.2026-08-05
Tirzepatide after intensive lifestyle intervention (SURMOUNT-3)
Nature Medicine 2023
Randomized controlled trialWeight reduction achieved after a lifestyle-intervention lead-in, used where we distinguish drug effect from lifestyle effect.2026-08-05
ClinicalTrials.gov study records
US National Library of Medicine
Trial registryRegistration, design, population, arms and endpoint for every trial in our library. Each trial page links directly to its own registry record by NCT number.2026-08-05
Boards of pharmacy directory
National Association of Boards of Pharmacy
Regulator directoryHow to reach the licensee lookup for each state regulator named on our state pages.2026-08-05
BeSafeRx — safely buying prescription medicines online
US Food and Drug Administration
Consumer guidanceThe consumer-facing checks behind our provider red-flag and verification pages.2026-08-05

Trial registry and DOI index

Every trial we summarize, with its registration record and digital object identifier. Our summary is a summary; the registry record and the published report are the evidence.

Trial library — 20 studies with registration identifiers.
TrialRegistrationDOI CitationOn this site
SURMOUNT-1NCT0418462210.1056/NEJMoa2206038N Engl J Med 2022;387:205-216Our summary
SURMOUNT-5NCT0582283010.1056/NEJMoa2416394N Engl J Med 2025;392:1929-1942Our summary
SURMOUNT-4NCT0466064310.1001/jama.2023.24945JAMA 2024;331:38-48Our summary
SURMOUNT-OSANCT0541200410.1056/NEJMoa2404881N Engl J Med 2024;391:1193-1205Our summary
SURPASS-2NCT0398791910.1056/NEJMoa2107519N Engl J Med 2021;385:503-515Our summary
SURPASS-CVOTNCT0425543310.1056/NEJMoa2500675N Engl J Med 2025 (presented ADA 2025)Our summary
SUMMITNCT0484755710.1056/NEJMoa2410027N Engl J Med 2025;392:427-437Our summary
SURMOUNT-3NCT0465701610.1038/s41591-023-02597-wNat Med 2023;29:2909-2918Our summary
SURMOUNT-2NCT0465700310.1016/S0140-6736(23)01200-XLancet 2023;402:613-626Our summary
ATTAIN-1NCT0586990310.1056/NEJMoa2511774N Engl J Med 2025 / FDA approval April 2026Our summary
STEP-1NCT0354893510.1056/NEJMoa2032183N Engl J Med 2021;384:989-1002Our summary
SELECTNCT0357459710.1056/NEJMoa2307563N Engl J Med 2023;389:2221-2232Our summary
STEP-8NCT0361158210.1001/jama.2021.23619JAMA 2022;327:138-150Our summary
GIP receptor pharmacology10.1038/s41574-023-00868-7Reviews in Cell Metab / Nat Rev Endocrinol 2023–2025Our summary
SURPASS-1NCT0395483410.1016/S0140-6736(21)01324-6Lancet 2021;398:143-155Our summary
SURPASS-3NCT0388297010.1016/S0140-6736(21)01443-4Lancet 2021;398:583-598Our summary
SURPASS-4NCT0373066210.1016/S0140-6736(21)02188-7Lancet 2021;398:1811-1824Our summary
SURPASS J-monoNCT0386105210.1016/S2213-8587(22)00188-7Lancet Diabetes Endocrinol 2022;10:623-633Our summary
Tirzepatide cardiovascular meta-analysisNot applicable — pre-specified meta-analysis of registered trials10.1038/s41591-022-01707-4Nat Med 2022;28:591-598Our summary
Time to weight plateau (SURMOUNT-1 and -4 analysis)NCT04184622 and NCT0466064310.1111/cob.12734Clin Obes 2025Our summary

What we do not source, and why

A citation that does not support the claim attached to it is worse than no citation. These are the claims on this site that rest on observation, commercial disclosure or judgment rather than on a citable authority, and we would rather say so than manufacture a reference.

Deliberately unsourced claims.
ClaimWhy there is no citation
Program pricesPrices are recorded from each program's own published material or, where flagged, from a named third-party review. They are commercial facts with no authoritative registry, they change without notice, and they carry a verification date rather than a citation. Where two sources disagree we publish both.
Service quality and shipping reliabilityWe hold no measurement of these we would defend, so we do not score them and do not cite anything for them.
Local clinic pricingThe $400–$600 range quoted on metro pages is a market observation, not a surveyed figure. It is labeled as such rather than presented as data.
Real-world versus trial resultsThe claim that real-world weight reduction runs below trial averages is well established across the class, but the precise gap varies by cohort and we do not attach a single number to it.

Machine-readable

The ledger is published as sources.json and sources.csv alongside the pricing and trial datasets, so an answer engine or a journalist can check what we cite without scraping this page.

Price your actual dose

Six dose tiers, sixteen tracked programs, twelve-month totals.

Open the calculator

Primary sources

Clinical, dosing and regulatory statements on this page rest on the documents below. Links go to the publisher, not to a summary of it. Prices are not sourced here — they carry a verification date instead, and the reason is set out in the source ledger.

  1. ZEPBOUND (tirzepatide) full prescribing information — DailyMed, US National Library of Medicine. Dose ladder, contraindications, warnings, storage.
  2. FDA’s concerns with unapproved GLP-1 drugs used for weight loss — US Food and Drug Administration. Compounded GLP-1 risks, API import alert, cold-chain complaints.
  3. FD&C Act provisions that apply to human drug compounding — US Food and Drug Administration. Why a compounded preparation is lawful without being FDA-approved.
  4. Tirzepatide once weekly for the treatment of obesity (SURMOUNT-1) — N Engl J Med 2022;387:205-216. Registration NCT04184622. The weight-reduction and adverse-event figures used across this site.
  5. The full source ledger — every primary source, what it supports, the date we read it, and the claims we deliberately do not source.