Drug facts

Oral tirzepatide

Reviewed August 2026

Every approved tirzepatide product is an injection¹

Two applications in Drugs@FDA contain tirzepatide as an active ingredient: NDA 215866, marketed as Mounjaro, and NDA 217806, marketed as Zepbound. Every product listed under both — single-dose vials, single-dose pens, autoinjectors and KwikPens — is recorded with the dosage form SOLUTION and the route SUBCUTANEOUS. There is no tablet, no capsule, no troche and no sublingual form among them.

That is the whole answer to the question most people are asking, and it has not changed. If you want the fuller picture of what the approved product is and what a compounded vial is not, that is set out in how compounded tirzepatide differs from Zepbound.

The oral pill that does exist is orforglipron²

Drugs@FDA records one approved application containing orforglipron: NDA 220934, brand name FOUNDAYO, sponsored by Eli Lilly and Company, with an original approval recorded on 1 April 2026. Its products are tablets taken by the oral route, in six strengths — 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg of orforglipron.

Orforglipron is not tirzepatide³

The FOUNDAYO label describes orforglipron as a GLP-1 receptor agonist that binds to and activates the human GLP-1 receptor. Its description section gives a small-molecule chemical formula and states that orforglipron calcium is insoluble in water. The dosing is oral, once daily, tablets swallowed whole.

Tirzepatide is a different kind of thing. Its own label calls it a GIP receptor and GLP-1 receptor agonist — two receptors, not one — and describes a peptide carrying a C20 fatty diacid that binds albumin. The two drugs share a target; they are not versions of each other, and evidence for one is not evidence for the other. What tirzepatide actually does is set out in how tirzepatide works on GIP and GLP-1 receptors.

What sellers mean by “oral tirzepatide”⁴

Compounding pharmacies do sell things under that name, and their own pages describe what they are. One markets a compounded oral disintegrating tablet formulation of tirzepatide that dissolves rapidly under the tongue without the need for water, in 3 mg, 4 mg and 5 mg strengths. Another sells tirzepatide as sublingual drops suspended in a proprietary base.

Both disclose their own status plainly. The first states that compounded medications are not FDA-approved medications, and FDA does not review compounded medications for safety or efficacy, and adds that its tablet has not undergone clinical trials. The second states that its preparation has not been approved by the FDA and has not undergone FDA review for safety, effectiveness, or quality. Those are the sellers’ words, not ours.

Why the route is not a detail⁵

There is no figure in the label for how much tirzepatide reaches the bloodstream when it is held under the tongue or swallowed, because no such product was submitted or reviewed. A dose printed on a troche is a quantity of drug placed in the mouth; it is not a statement about how much arrives anywhere. That gap between the number on the package and the amount delivered is the same problem, in a different form, as the one described in the approved dosing schedule and how it steps up.

Where this sits legally⁶

The molecule in an approved vial and the molecule named on a troche may be given the same name, but only one of them sits inside an application that FDA reviewed. Nothing about the oral route inherits the evidence built for the injection. We keep the current regulatory position separately, on where compounded tirzepatide stands legally, and our checking method is written up under how we verify what is on this site.