> ## Documentation Index
> Fetch the complete documentation index at: https://docs.hi-doctor.ai/llms.txt
> Use this file to discover all available pages before exploring further.

# Zepbound — why it is not prescribed in the EU

> Zepbound (tirzepatide): why it has no EU marketing authorisation under that name, the SURMOUNT-1 trial results, and the EU alternative, Mounjaro.

Zepbound is the United States brand name for tirzepatide and holds no EU marketing authorisation — the European Medicines Agency has no assessment report under this name. In the European Union the same active substance is sold as Mounjaro.

## What is Zepbound?

Tirzepatide is given as a once-weekly injection under the skin. It acts on two natural gut-hormone signals at once, GLP-1 and GIP, which together lower appetite and slow how fast food leaves the stomach, so people usually eat less. In the United States, Zepbound is labelled by Eli Lilly and Company for weight reduction and for moderate to severe obstructive sleep apnoea in adults with obesity.

<Info>
  Form: pre-filled injection pen. Frequency: once a week. Status: prescription only.
</Info>

<Warning>
  Zepbound has no EU marketing authorisation for this use. No doctor in the EU can prescribe it for this use — including ours. It may be authorised in another country, or for a different condition.
</Warning>

## Not marketed in the EU

In the EU, the same active substance is sold as Mounjaro. Tirzepatide was first authorised in September 2022 for type 2 diabetes, and its licence was extended on 11 December 2023 to cover weight management alongside a reduced-calorie diet and more physical activity.

## How it works

It switches on two gut-hormone receptors at the same time, GIP and GLP-1, which together reduce appetite and slow how quickly the stomach empties.

## What the studies reported

<Note>
  Figures are the treatment-regimen estimand at week 72 from SURMOUNT-1. People with type 2 diabetes were excluded, everyone also received diet and exercise counselling, and the trial did not follow weight after treatment stopped. Every NCT identifier links to its ClinicalTrials.gov record; a readout is not the same as peer-reviewed publication.
</Note>

<AccordionGroup>
  <Accordion title="Sources">
    * ClinicalTrials.gov · NCT04184622 (SURMOUNT-1)
  </Accordion>
</AccordionGroup>

## What has been reported

| Effect                                    | 5 mg  | 10 mg | 15 mg | Placebo |
| ----------------------------------------- | ----- | ----- | ----- | ------- |
| Nausea                                    | 24.6% | 33.3% | 31.0% | 9.5%    |
| Diarrhoea                                 | 18.7% | 21.2% | 23.0% | 7.3%    |
| Constipation                              | 16.8% | 17.1% | 11.7% | 5.8%    |
| Vomiting                                  | 8.3%  | 10.7% | 12.2% | 1.7%    |
| Hair thinning (alopecia)                  | 5.1%  | 4.9%  | 5.7%  | 0.9%    |
| Stopped treatment because of side effects | 4.3%  | 7.1%  | 6.2%  | 2.6%    |

Acute pancreatitis was independently confirmed in 3 people on tirzepatide and 1 on placebo across the SURMOUNT-1 safety dataset reviewed by the EMA.

## What SURMOUNT-1 did not measure

SURMOUNT-1 did not follow weight after treatment stopped, so it provides no data on what happens when tirzepatide is discontinued. People with type 2 diabetes were excluded from the trial, meaning the side-effect profile in that group is drawn from a different dataset. All participants also received diet and exercise counselling, so the figures reflect the medicine alongside lifestyle support, not the medicine alone.

## Common questions

<AccordionGroup>
  <Accordion title="Can I get Zepbound from an EU pharmacy?">
    No. Zepbound has no EU marketing authorisation, so no doctor in the EU can
    prescribe it for this use. The same active substance, tirzepatide, is sold
    in the EU under the brand name Mounjaro, which was first authorised for
    type 2 diabetes in September 2022 and extended to weight management on
    11 December 2023.
  </Accordion>

  <Accordion title="How does Zepbound compare with Mounjaro?">
    Zepbound and Mounjaro contain exactly the same active substance —
    tirzepatide — at the same doses. Zepbound is the US brand name; Mounjaro
    is the EU brand name. The dosing schedule, side-effect profile and
    clinical trial data (SURMOUNT-1) are the same.
  </Accordion>

  <Accordion title="What happens if I stop taking tirzepatide?">
    SURMOUNT-1 did not follow weight after treatment stopped. As with other
    GLP-1-based medicines, appetite and stomach emptying return to normal once
    the medicine leaves the body, and weight that was lost may be regained.
  </Accordion>

  <Accordion title="Is tirzepatide the same as semaglutide?">
    No. Tirzepatide acts on two receptors (GIP and GLP-1), while semaglutide
    acts only on GLP-1. Both are once-weekly injections, but they are
    different molecules with different trial programmes and different
    authorised doses.
  </Accordion>

  <Accordion title="Can tirzepatide cause hair thinning?">
    In SURMOUNT-1, alopecia was reported by 5.1% (5 mg), 4.9% (10 mg) and
    5.7% (15 mg) of participants versus 0.9% on placebo. The mechanism is not
    fully understood, but it is listed in the trial safety data.
  </Accordion>
</AccordionGroup>

## A step-wise, supervised escalation (as used for tirzepatide in the EU)

<Steps>
  <Step title="Weeks 1–4">
    2.5 mg starting dose, once weekly.
  </Step>

  <Step title="From week 5">
    Step up every 4 weeks as tolerated: 5 → 7.5 → 10 → 12.5 mg.
  </Step>

  <Step title="Month 4+">
    Personalised maintenance dose, up to a maximum of 15 mg per week.
  </Step>

  <Step title="Ongoing">
    Quarterly medical reviews.
  </Step>
</Steps>

Once-weekly self-injection is given in the thigh, abdomen or upper arm, and is combined with diet and physical activity — tirzepatide complements, not replaces, lifestyle change.

## Who it is not suitable for

* Personal or family history of medullary thyroid carcinoma or MEN 2
* Pregnancy, planned pregnancy in the next 2 months, or breastfeeding
* History of pancreatitis
* Type 1 diabetes or diabetic ketoacidosis
* Severe gastroparesis

<Note>
  You pay for any medication separately at the pharmacy you choose. Hi-Doctor does not sell medications.
</Note>

## How Hi-Doctor handles it

Weight-loss treatment runs as an ongoing plan: first consultation included, then renewals reviewed by your doctor as part of ongoing care. See the [weight management programme](/library/treatments/weight-management-program) for how the categories work, and [pricing](/essentials/pricing) for how the plan is billed. Related: [Qsymia](/library/medicines/qsymia), another US weight-loss medicine without EU-wide authorisation. For the EU-authorised version of tirzepatide, see [Mounjaro](/library/medicines/mounjaro). For other weight-management options, see [semaglutide (Wegovy)](/library/medicines/wegovy) and the full [treatment areas](/essentials/treatments) Hi-Doctor covers.

## Start a consultation

<Card title="Weight-loss consultation" icon="stethoscope" href="https://hi-doctor.ai/consultation/weight-loss/1">
  Answer the weight-loss questionnaire and a registered doctor reviews it.
  They decide whether treatment is appropriate, which one, and at what dose —
  and declining is a normal outcome. See [what it costs](/essentials/pricing)
  and [how the review works](/essentials/how-it-works).
</Card>

<Warning>
  This page is reference information, not medical advice and not a prescription.
  Whether a medicine is appropriate for you is decided by a registered doctor
  after reviewing your consultation.
</Warning>