Oral Tirzepatide (2025): Availability, Trials, and How to Talk to Your Clinician

October 7, 2025

Last Updated: Oct 07, 2025

Weight Loss
10 min read

As of October 2025, there is no FDA-approved oral tirzepatide. See availability, trials, and how to talk to your clinician.

Key takeaways
  • No FDA-approved oral tirzepatide formulations exist as of October 2025.
  • Compounding medications containing tirzepatide is only permitted when a licensed provider documents a clinically significant difference for an identified patient. Compounded medications are not FDA-approved for safety, efficacy, or quality.
  • Only injectable tirzepatide has clinical evidence supporting its efficacy.
  • Research on oral GLP-1 and dual GLP-1/GIP options, like tirzepatide, continues but faces significant formulation challenges.

Important note: Compounded GLP-1 therapies are prepared only when a licensed provider determines a clinically significant difference for an identified patient. These medications are not reviewed or approved by the FDA for safety, efficacy, or quality. Eden coordinates care; licensed providers evaluate and prescribe; partner pharmacies dispense and label. Eden and partner clinics do not offer oral tirzepatide.

You may be wondering if an oral tirzepatide pill is available yet. As of October 2025, the answer is no because the FDA hasn’t approved any oral formulations yet. Pharmacies may not compound tirzepatide unless a provider documents a clinically significant difference for an identified patient.

Several telehealth companies market compounded, orally administered tirzepatide (e.g., sublingual or rapid-dissolve tablets). These products are not FDA-approved and may lack published clinical studies that demonstrate their safety or effectiveness. 

Large clinical studies support the effectiveness of the injectable form of tirzepatide for weight management. See below for details on what researchers tested and what they found.

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Trials in Context

In the SURMOUNT-1 trial (adults without diabetes), participants lost an average of ~20% of their body weight over 72 weeks, depending on the dose, compared to the placebo group. The SURMOUNT-2 trial showed substantial weight reduction in people with both obesity and type 2 diabetes.*

Researchers are still testing oral GLP-1 and GLP-1/GIP medicines. Results may differ by drug type and dose and are only comparable when the drugs tested are head-to-head in the same study. Individual results vary based on dose, adherence, and clinical factors. Clinical trials progress through four phases to evaluate safety and effectiveness. Any future oral tirzepatide must meet these standards before FDA approval. As of October, 2025, no oral tirzepatide has.

*The SURMOUNT-1 and SURMOUNT-2 trials both used the once-weekly subcutaneous Zepbound® formulation of tirzepatide, approved to treat adults with chronic weight management with at least one weight-related condition.

Why a “Tirzepatide Pill” is Hard

Developers face biological obstacles when they attempt an oral tirzepatide. Tirzepatide is a dual-action peptide that meets a harsh environment in the digestive tract. Injectable forms bypass these barriers by delivering the drug subcutaneously (under the skin). Any “tirzepatide pill” would need sophisticated delivery. For example, it would need absorption enhancers or protective carriers.

Developers have advanced other GLP-1s already. For instance, oral semaglutide uses an absorption-enhancing approach. But what works for one molecule may not work for another, and researchers continue to test what is possible. Only strong clinical data can establish the performance of any future oral tirzepatide, and science just isn’t there yet.

Talk to Your Clinician

Discuss tirzepatide, or any weight-management medication, with a licensed healthcare professional. Whether you’re already using tirzepatide or just considering it, start by discussing goals, medical history, and what “success” may look like to you. Your clinician can decide if tirzepatide is clinically appropriate, outline a dosing plan (if applicable), and explain common side effects, rare risks, and how treatment is monitored.

Ask broadly about alternatives if tirzepatide isn’t the best match. Also ask about supportive care: nutrition, activity, and behavioral strategies, since these typically influence outcomes.

If you’re new to tirzepatide therapy, discuss how tirzepatide may interact with other medications. And if you’re already on tirzepatide, use visits to review progress, adjust dose for tolerability (if applicable), and troubleshoot practical issues like missed doses, travel, and pharmacy fulfillment.

Bring and discuss:

  • Your medical history 
  • All medications and supplements you take
  • Previous weight-management attempts and outcomes

Your provider may order baseline labs (e.g., kidney, liver, thyroid) and review potential side effects, from common GI symptoms to rare, serious risks. If you prefer an oral option, your clinician can review FDA-approved alternatives and whether any fit your health profile.

About Compounded Products

Compounding creates an individualized medication for specific patient needs. Compounded tirzepatide is different from FDA-approved medications. Mounjaro® and Zepbound® underwent FDA review for safety and effectiveness, while compounded versions have not. The brand that makes medications containing tirzepatide does not sell its raw drug ingredient to compounding pharmacies. If you’re offered compounded tirzepatide, ask the pharmacy where they get the ingredient and how they verify it’s high quality.

Important note: Compounded GLP-1 therapies are prepared only when a licensed provider determines a clinically significant difference for an identified patient. These medications are not reviewed or approved by the FDA for safety, efficacy, or quality.

Conclusion

As of October 2025, the FDA has not approved any oral tirzepatide medications. Providers prescribe tirzepatide as a subcutaneous injection. Pharmacies do not compound tirzepatide unless a provider determines a clinically significant difference for an identified patient.

Researchers continue to evaluate oral options, and feasibility and timelines depend on study results and regulatory review. Currently, there are only injectable medications containing tirzepatide that are FDA-approved.

Discuss weight-management options with your healthcare provider, including risks, benefits, and monitoring, and pair medication with nutrition, activity, and behavioral support under licensed healthcare guidance.

Disclaimer: The FDA does not approve compounded medications for safety, quality, or manufacturing. Prescriptions and a medical evaluation are required for certain products. The information provided on this blog is for general informational purposes only. It is not intended as a substitute for professional advice from a qualified healthcare professional and should not be relied upon as personal health advice. The information contained in this blog is not meant to diagnose, treat, cure, or prevent any disease. Readers are advised to consult with a qualified healthcare professional for any medical concerns, including side effects. Use of this blog's information is at your own risk. The blog owner is not responsible for any adverse effects or consequences resulting from the use of any suggestions or information provided in this blog.

Eden is not a medical provider. Eden connects individuals with independent licensed healthcare providers who independently evaluate each patient to determine whether a prescription treatment program is appropriate. All prescriptions are written at the sole discretion of the licensed provider. Medications are filled by state-licensed pharmacies. Please consult a licensed healthcare provider before making any medical decisions.

Frequently asked questions

Is an oral version of tirzepatide currently available?

As of October 2025, the FDA has not approved oral tirzepatide. The only approved form is an injection. Researchers continue to study oral formulations.

How effective is injectable tirzepatide for weight loss?

Clinical trials show substantial weight loss over time under medical supervision. Results vary by dose, population, and adherence.

What should I discuss with my healthcare provider about tirzepatide?

Ask if it is clinically appropriate based on your medical history, baseline tests, monitoring plans, potential side effects, and lifestyle supports.

Who might not be a suitable candidate for tirzepatide treatment?

This depends on labeled indications, contraindications, and clinical judgment. Share your medical history, including endocrine conditions, pancreatitis history, pregnancy and breastfeeding status, and age with your provider.

Eden is an independent healthcare platform and is not affiliated with, endorsed by, or sponsored by Eli Lilly and Company.

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References

Eli Lilly and Company. (2022). HIGHLIGHTS OF PRESCRIBING INFORMATION. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf

Garvey, W. T., Frias, J. P., Jastreboff, A. M., Roux, C. W. L., Sattar, N., Aizenberg, D., Mao, H., Zhang, S., Ahmad, N. N., Bunck, M. C., Benabbad, I., Zhang, X. M., Abalos, F. H., Manghi, F. C., Zaidman, C. J., Vico, M. L., Aizenberg, D., Costanzo, P. R., Serra, L. P., . . . Jones, T. (2023). Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. The Lancet, 402(10402), 613–626. https://doi.org/10.1016/s0140-6736(23)01200-x

HIGHLIGHTS OF PRESCRIBING INFORMATION. (2023). [Prescribing information]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf

Jastreboff, A. M., Aronne, L. J., Ahmad, N. N., Wharton, S., Connery, L., Alves, B., Kiyosue, A., Zhang, S., Liu, B., Bunck, M. C., & Stefanski, A. (2022). Tirzepatide once weekly for the treatment of obesity. New England Journal of Medicine, 387(3), 205–216. https://doi.org/10.1056/nejmoa2206038