Metabolic · Dosing reference

Orforglipron dosage

Dosing as the FDA label states it, how long trials ran, and the arithmetic for working with vials.

FDA-approvedAHuman trial evidenceFDA label

Full research page Cycle-length evidence Compare Prefer Amiravo on Google

Regulatory status: FDA-approved
Human amounts: 0.8 mg once daily to start, escalated stepwise (2.5, 5.5, then optionally 9, 14.5, 17.2 mg) after at least 30 days per step; maximum 17.2 mg once daily (FOUNDAYO label)
Route studied: Oral tablet
Frequency: Once daily, with or without food
Half-life: Approximately 29-49 hours
Evidence grade: Grade A · Human trial evidence
Vial sizes on the market: Not recorded
Other forms seen: —

What Orforglipron is

Orforglipron is an oral, once-daily small-molecule (non-peptide) GLP-1 receptor agonist that the FDA approved in April 2026 as Foundayo for chronic weight management in adults with obesity or overweight with a weight-related condition.

Orforglipron binds the human GLP-1 receptor as a partial agonist biased toward G protein activation over beta-arrestin recruitment, occupying a pocket in the upper helical bundle formed by the extracellular domain, extracellular loop 2 and transmembrane helices 1, 2, 3 and 7 ^3. Species selectivity Its interaction with the primate-specific Trp33 of the receptor extracellular domain explains species-selective… How it works →

Key evidence

Wharton et al., N Engl J Med (ATTAIN-1) · 2025 · Humans (3127 adults with obesity without diabetes)
Body-weight change -7.5%, -8.4% and -11.2% with 6, 12 and 36 mg versus -2.1% with placebo; adverse events led to discontinuation in 5.3-10.3% versus 2.7% ^4. ⁴
Rosenstock et al., N Engl J Med (ACHIEVE-1) · 2025 · Humans (559 adults with type 2 diabetes on diet and exercise)
HbA1c change -1.24 to -1.48 percentage points versus -0.41 with placebo; no severe hypoglycemia reported ^5. ⁵
Rosenstock et al., Lancet (ACHIEVE-3) · 2026 · Humans (1698 adults with type 2 diabetes on metformin)
HbA1c reductions with orforglipron 12 and 36 mg were non-inferior and superior to oral semaglutide 7 and 14 mg; discontinuation for adverse events was 9-10% versus 4-5% ^6. ⁶

All studies on the research page

Schedules by time period

Label regimens and laid out week by week. Each bar is what the label states or what investigators gave participants; none is a recommendation.

FDA label

FOUNDAYO (FDA label): dosage escalation ¹

Adults with obesity, or overweight with at least one weight-related comorbid condition

FOUNDAYO tablets

oral · once daily

Week-by-week table

Period	Amount
Weeks 0–onward	0.8 mg
Weeks 5–onward	2.5 mg
Weeks 9–onward	5.5 mg (maintenance)
Weeks 13–onward	9 mg (maintenance)
Weeks 18–onward	14.5 mg (maintenance)
Weeks 22–onward	17.2 mg (maintenance)

Maximum 17.2 mg once daily (9 mg with a strong CYP3A4 inhibitor).

Each step requires at least 30 days; week numbers shown are the earliest possible. Escalation beyond 5.5 mg is optional, based on response and tolerability.

Dosing as stated on the FDA label

For chronic weight management (FOUNDAYO): start at 0.8 mg orally once daily; after at least 30 days increase to 2.5 mg, then after at least 30 days to 5.5 mg once daily ^1.
The dosage may be increased to the next level (9 mg, 14.5 mg or 17.2 mg once daily) after at least 30 days on the current dosage based on response and tolerability; the maximum is 17.2 mg once daily, and no more than one tablet should be taken per day ^1.
With a strong CYP3A4 inhibitor the maximum dosage is 9 mg once daily; strong CYP3A4 inhibitors that also inhibit OATP1B and strong CYP3A4 inducers should be avoided ^1.
If 7 or more consecutive doses are missed, the label advises reinitiating escalation at a lower dosage ^1.
Label efficacy and safety data come from an investigational orforglipron formulation presented as equivalent FOUNDAYO dosages; the trial publications report capsule doses (for example 36 mg), which ACHIEVE-4 states is equivalent to the 17.2 mg tablet ^1,7.

How long did human studies run?

No human study durations are recorded for Orforglipron.

Cycle-length evidence for Orforglipron

Side effects reported in studies

Nausea
26% (5.5 mg), 34% (9 mg), 35% (17.2 mg) versus 10% placebo · Adults with obesity or overweight, pooled Trials 1 and 2 (up to 72 weeks) ¹
Constipation
20%, 27%, 24% versus 9% · Same pooled trials ¹
Diarrhea
21%, 23%, 25% versus 11% · Same pooled trials ¹
Vomiting
13%, 21%, 24% versus 4% · Same pooled trials ¹
Dyspepsia
12%, 16%, 13% versus 4% · Same pooled trials ¹
Hair loss
4%, 4%, 5% versus 2% · Same pooled trials ¹
Discontinuation due to adverse reactions
8% overall (6%, 9%, 10%) versus 3% placebo · Same pooled trials ¹
Hypoglycemia (glucose below 54 mg/dL)
2% versus 0.2% placebo; 7% when combined with a sulfonylurea · Adults with type 2 diabetes and BMI of 27 or more (Trial 2) ¹

Full adverse-event data

Supplies and handling

Lyophilized vial
Sealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
Sterile diluent
The diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
Graduated syringes
Sized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
Alcohol prep pads
For wiping vial stoppers before each puncture.
Nitrile gloves
Clean gloves for aseptic handling.
Sharps container
Puncture-resistant container for used needles.

Step-by-step reconstitution guide Storage and transport accessories

Storage

Store approved tablets as directed in the current label; research materials per supplier documentation.

Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.

Handling mistakes and troubleshooting

Added the wrong volume of diluent: The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.
Shook the vial and it foamed: Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.
The solution is cloudy or has particles: Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.
The powder cake looks melted or shrunken before reconstitution: This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.
Liquid sprayed back when the needle was removed: Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.

Regulatory status

Status: FDA-approved as FOUNDAYO tablets (NDA 220934, original approval April 1, 2026) for reducing excess body weight and maintaining reduction long term in adults with obesity, or overweight with at least one weight-related comorbid condition, with diet and physical activity; the label is current as of the August 13, 2026 DailyMed version and does not include a type 2 diabetes indication ^1,2.
United States (FDA): FDA-approved under NDA 220934 (FOUNDAYO, Eli Lilly and Co.), original approval April 1, 2026, per Drugs@FDA records retrieved 2026-10-24 ^2; label reviewed from the August 13, 2026 DailyMed version ^1.
Sport (WADA): Orforglipron is not named in the 2026 Prohibited List text reviewed; it is not a peptide hormone and, being approved, is outside the S0 non-approved class ^8.

Status varies by country and changes over time. How we describe regulatory status.

Orforglipron compared with related compounds

Compound	Status	Evidence	Human amounts	Half-life
Orforglipron	FDA-approved	A	FDA label	Approximately 29-49 hours
Semaglutide	FDA-approved	A	FDA label	Approximately 1 week; present in the cir
Liraglutide	FDA-approved	A	FDA label	Approximately 13 hours after subcutaneou
Tesofensine	Investigational	B	Trial doses	About 234 hours (M1 metabolite about 374
Mazdutide	Approved outside the US	A	Trial doses	150.9 to 403.5 hours (phase 1b in overwe
Cagrilintide	Investigational	A	Trial doses	159 to 195 hours (phase 1b, co-administe

Frequently asked questions

What doses of Orforglipron have been studied in humans?

Orforglipron is FDA-approved, so the label states the dosing for the approved product. This page quotes it, with citations. It does not apply to research-grade material.

Is there an established Orforglipron cycle length?

No. We found no human studies that report treatment duration for Orforglipron.

How much bacteriostatic water should be added to a Orforglipron vial?

There is no compound-specific volume. The diluent volume only sets the concentration: concentration = mass in the vial ÷ volume added (for example, 10 mg in 2 mL gives 5 mg/mL). The calculator on this page shows the arithmetic for any combination.

How many units is a given amount on an insulin syringe?

On a U-100 syringe, 100 units = 1 mL. Units for an amount = amount ÷ (concentration per unit). The calculator converts any amount you enter at the concentration you choose; a unit is a volume mark, not an amount of compound.

What is the half-life of Orforglipron?

Approximately 29-49 hours

Is Orforglipron FDA-approved?

FDA-approved. FDA-approved as FOUNDAYO tablets (NDA 220934, original approval April 1, 2026) for reducing excess body weight and maintaining reduction long term in adults with obesity, or overweight with at least one weight-related comorbid condition, with diet and physical activity; the label is current as of the August 13, 2026 DailyMed version and does not include a type 2 diabetes indication ^1,2.

References

FOUNDAYO (orforglipron) tablets, for oral use, prescribing information (DailyMed SPL version 10, published Aug 13, 2026) FDA label (DailyMed). 2026
Drugs@FDA application NDA 220934 (FOUNDAYO, Eli Lilly and Co; original approval 2026-04-01) via openFDA FDA (openFDA Drugs@FDA). 2026
Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist Proc Natl Acad Sci U S A. 2020
Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment N Engl J Med. 2025
Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes N Engl J Med. 2025
Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (ACHIEVE-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial Lancet. 2026
Cardiovascular safety of orforglipron versus insulin glargine in adults with type 2 diabetes at increased cardiovascular risk (ACHIEVE-4): a phase 3, event-driven, randomised, open-label, non-inferiority, active comparator trial Lancet. 2026
Tractatenblad 2026 Nr. 25: Anti-doping convention (ETS No. 135), amendment to the appendix - The 2026 Prohibited List, World Anti-Doping Code (English text; entry into force 1 January 2026) Tractatenblad van het Koninkrijk der Nederlanden (official government publication). 2026
PubChem compound record for orforglipron (CID 137319706) PubChem. 2026

Last reviewed October 24, 2026 by the Amiravo editorial team. Editorial policy · Report an error