TrackurStackevidence-graded reference + tracker
Semaglutide
fig.1 — stylized molecular motif
Metabolic

Semaglutide

Ozempic · Wegovy · Rybelsus

Largest absolute brand-search footprint of any peptide; the cultural event that normalized injectables; oral Wegovy approved 22 Dec 2025.

Evidence
AFDA-approved RCTs
Status
FDA-approvedas of 2026-06
Approval
FDA-approved
Category
Metabolic
Route
Subcutaneous · Oral
Demand rank
#1 most-searched
Compare Semaglutide with another
01Dosing & Protocol
Typical · reference only
Wegovy SC 2.4 mg once weekly (maintenance; HD 7.2 mg optional); Ozempic 0.5-2 mg weekly; oral Wegovy 25 mg daily; Rybelsus 7-14 mg daily
Titration
Wegovy SC 16-wk: 0.25>0.5>1.0>1.7>2.4 mg (4 wks each)
Reconstitution — illustrative, not a recommendation
Compounded (illustrative): 5 mg vial + 2.0 mL BAC water = 2.5 mg/mL; 0.25 mg = 10 U, 2.4 mg = 96 U on U-100. Wrong concentration drives the documented 5-20x overdoses.
Reconstitution calculatorlive tool
10units
on a U-100 syringedraw to the 10 mark
020406080100
Concentration2.5 mg/mL
Draw volume0.1 mL
Illustrative, not a recommendation. mg vs mcg confusion drives 5–1000× overdoses — always recompute for your own vial and syringe.
Missed dose: Wegovy: 2-day rule (NOT Ozempic's 5-day rule). Units are not milligrams. mg-vs-mcg confusion drives documented 5–1000× overdoses — always recompute for your own vial.
02Regulatory Status
Removal from Category 2 ≠ legal to compound ≠ FDA-approved. Compounded semaglutide is largely cornered now the shortage has resolved; salt forms (sodium/acetate) are different actives with no lawful basis.
Pre-clinical
Phase 1
Phase 2
Phase 3
Approved
Status
FDA-approved
503A bulks
Not on the bulks list
Category 2
n/a (approved drug)
PCAC review
none scheduled
WADA
Not listed
03Evidence — the honest read
What the evidence actually shows

Multiple large RCTs; SELECT 20% MACE reduction; MASH accelerated approval (Aug 2025). Tirzepatide beats it on weight loss.

What grade A means — how we grade →
04Safety
Contraindications
  • Personal/family medullary thyroid carcinoma or MEN-2hard stop
  • Pregnancy/breastfeedinghard stop
  • Pancreatitis history (relative)
Key interactions
  • Insulin/sulfonylureas -> hypoglycemia (warning; reduce those agents)
  • Oral contraceptives (caution; less than tirzepatide)
  • Anesthesia/sedation -> retained gastric contents/aspiration (warning)
  • Warfarin/NTI oral drugs -> more frequent INR (caution)
Serious signals
  • Acute pancreatitis
  • Gallbladder disease
  • Dehydration->AKI with vomiting
  • Dysesthesia ~22% on HD 7.2 mg
Monitoring
Glucose (esp. with insulin/SU); watch pancreatitis/gallbladder; renal function if GI losses.
05Related in Metabolic
Tirzepatide
FDA-approved RCTs
grade A →
Retatrutide
human trials
grade B →
Cagrilintide / CagriSema
human trials
grade B →
MOTS-c
animal-only
grade D →
06Sources

The primary sources behind this monograph — each opens the registry so you can verify the claim yourself. Last verified 2026-06-13.

FDA labelFDA label — application 209637FDA approval & label · NDA/BLA 209637How we source & verify — the full method →

Beyond these primaries, every monograph is distilled from TrackurStack’s research dossier — 584 de-duplicated sources across 4 research iterations, adversarially verified against primary sources.

Not medical or legal advice. Educational / harm-reduction reference. Regulatory and dosing claims in this field move monthly — re-verify against primary sources (FDA docket FDA-2025-N-6895, DailyMed, ClinicalTrials.gov) before acting.
Last reviewed — 2026-06-13 · confidence: high
Metabolic

Semaglutide

Ozempic · Wegovy · Rybelsus · oral Wegovy

Largest absolute brand-search footprint of any peptide; the cultural event that normalized injectables; oral Wegovy approved 22 Dec 2025.

Evidence
A
FDA-approved RCTs
Status
FDA-approved
as of 2026-06
FDA approval
Approved
on-label use exists
Route
Subcutaneous · Oral
FDA label
Demand
#1
most-searched
WADA
Not listed
sport-legal
01

Dosing & protocol

FDA label. Dosing reference per the FDA label.
Typical — reference only

Wegovy SC 2.4 mg once weekly (maintenance; HD 7.2 mg optional); Ozempic 0.5-2 mg weekly; oral Wegovy 25 mg daily; Rybelsus 7-14 mg daily

Worked reconstitution example

Compounded (illustrative): 5 mg vial + 2.0 mL BAC water = 2.5 mg/mL; 0.25 mg = 10 U, 2.4 mg = 96 U on U-100. Wrong concentration drives the documented 5-20x overdoses.

Titration

Wegovy SC 16-wk: 0.25>0.5>1.0>1.7>2.4 mg (4 wks each)

Missed dose: Wegovy: 2-day rule (NOT Ozempic's 5-day rule). Units are not milligrams. mg-vs-mcg confusion drives documented 5–1000× overdoses — always recompute for your own vial (use the calculator →).
02

Regulatory status

Removal from Category 2 ≠ legal to compound ≠ FDA-approved. Compounded semaglutide is largely cornered now the shortage has resolved; salt forms (sodium/acetate) are different actives with no lawful basis.
Pre-clinical
Phase 1
Phase 2
Phase 3
Approved
StatusFDA-approved
503A bulksNot on the bulks list
Category 2 (2026)n/a (approved drug)
PCAC reviewnone scheduled
WADANot listed
03

Evidence — the honest read

AFDA-approved RCTs

Multiple large RCTs; SELECT 20% MACE reduction; MASH accelerated approval (Aug 2025). Tirzepatide beats it on weight loss.

What grade A means · how we grade
04

Safety

Contraindications
  • Personal/family medullary thyroid carcinoma or MEN-2hard stop
  • Pregnancy/breastfeedinghard stop
  • Pancreatitis history (relative)
Key interactions
  • Insulin/sulfonylureas -> hypoglycemia (warning; reduce those agents)
  • Oral contraceptives (caution; less than tirzepatide)
  • Anesthesia/sedation -> retained gastric contents/aspiration (warning)
  • Warfarin/NTI oral drugs -> more frequent INR (caution)
Serious signals
  • Acute pancreatitis
  • Gallbladder disease
  • Dehydration->AKI with vomiting
  • Dysesthesia ~22% on HD 7.2 mg
Monitoring

Glucose (esp. with insulin/SU); watch pancreatitis/gallbladder; renal function if GI losses.

06

Sources

The primary sources behind this monograph — each opens the registry so you can verify the claim yourself. Last verified 2026-06-13.

FDA labelFDA label — application 209637FDA approval & label · NDA/BLA 209637How we source & verify — the full method →

Beyond these primaries, every monograph is distilled from TrackurStack’s research dossier — 584 de-duplicated sources across 4 research iterations, adversarially verified against primary sources.

Not medical or legal advice. Educational / harm-reduction reference. Regulatory and dosing claims in this field move monthly — re-verify against primary sources (FDA docket FDA-2025-N-6895, DailyMed, ClinicalTrials.gov) before acting.
Last reviewed — 2026-06-13 · confidence: high