Peptide Intelligence · GLP-1
Tirzepatide
Also: Mounjaro, Zepbound
A dual GIP and GLP-1 receptor agonist injected weekly. Acts on two gut-hormone pathways to lower appetite and improve glucose handling.
Approval status
FDA-approved
Type 2 diabetes (Mounjaro); chronic weight management and obstructive sleep apnea in adults with obesity (Zepbound).
Compounding status
Approved product · compounded versions are unapproved
Compounded tirzepatide is not FDA-approved. FDA has received more than 730 adverse-event reports for compounded tirzepatide as of May 31 2026 and has proposed excluding it from the 503B bulks list (Apr 30 2026).
Evidence grade
A · Human randomized trials
SURMOUNT and SURPASS phase 3 programs. In the SURMOUNT-1 DXA substudy roughly 25% of the weight lost was lean mass.
Known risks and label warnings
- Boxed warning: thyroid C-cell tumors in rodents; contraindicated with personal or family history of MTC or MEN 2
- Pancreatitis; gallbladder disease; acute kidney injury from dehydration; severe GI reactions
- Hypoglycemia with insulin or sulfonylureas
- Pulmonary aspiration under anesthesia
Interactions people ask about
- Insulin and sulfonylureas
- Oral contraceptives: reduced exposure after initiation and dose escalation (label advises backup contraception for 4 weeks)
What people often measure
Framed as things to discuss with your clinician, not a protocol.
- Weight, waist, lean mass
- Protein intake and resistance training
- Hydration and GI symptoms after dose
- Glucose/A1c if diabetic
Questions for your clinician
- Should I have a baseline DEXA?
- What protein and strength-training targets fit my situation?
- How should I handle a supply gap or a switch between products?
Get the full report by email
- The Tirzepatide status card, monitoring list and clinician questions, printable
- The pre-therapy baseline checklist: what people commonly measure before starting any injectable
- A note the next time FDA or HHS acts on this compound
Wellness guidance only, not medical advice. We never sell or dispense medication.
Regulatory timeline for Tirzepatide
2026-09-01
FDA updates its 'concerns with unapproved GLP-1 drugs' page
As of May 31 2026 FDA had received 990 adverse-event reports for compounded semaglutide and more than 730 for compounded tirzepatide, including dosing errors of 5–20×.
FDA: concerns with unapproved GLP-1 drugs2026-04-30
FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list
The proposal would end outsourcing-facility compounding of the three GLP-1s from bulk substance. Comments closed Jun 29 2026. If finalized, many compounded-GLP-1 users will face a supply transition.
FDA press announcement2026-01-13
FDA requests removal of the suicidal-ideation warning from GLP-1 labels
After review, FDA asked manufacturers to remove the suicidal behavior and ideation warning from Wegovy, Saxenda and Zepbound labels. Ozempic never carried it.
FDA Drug Safety Communication2024-07-26
FDA alerts on dosing errors with compounded GLP-1s
FDA warned health-care providers, compounders and patients about dosing errors from multi-dose vials and unit confusion with compounded semaglutide and tirzepatide.
FDA dosing-error alert
Sources and review
- SURMOUNT-1 DXA substudy (Look et al., Diabetes Obes Metab 2025)
- FDA: concerns with unapproved GLP-1 drugs (updated Sep 1 2026)
Status as of 2026-09-02. Reviewed 2026-09-02 by Curtis Holder (product); clinical review pending; next review due 2026-12-01. Regulatory status changes; we update this page after each FDA or HHS action. Wellness guidance only, not medical advice. Med.xyz does not sell, prescribe or recommend any compound.