APPROVED
VYKAT XR, March 2025, age 4 and older. First drug on this indication.
DRUGS
In 2025 the FDA approved one hyperphagia drug. The same year a phase 3 oxytocin analogue failed.
VYKAT XR (diazoxide choline) was approved on 26 March 2025 for hyperphagia in people with PWS aged 4 and older. In September, COMPASS PWS tested nasal carbetocin in 175 people and missed the primary HQ-CT endpoint and every secondary endpoint. Development stopped. Setmelanotide has 6-month open-label Phase 2 poster data, not a Phase 3 result.
| Row | What is true | What it is not |
|---|---|---|
| VYKAT XR (diazoxide choline) | FDA approved 26 March 2025 for hyperphagia in adults and children 4 and older with PWS. First label on that indication. | Not a cure. Not a lock replacement. Not approved under age 4. Safety reporting continues. We do not dose it here. |
| Carbetocin nasal (ACP-101) | COMPASS PWS, 175 people, ages 5 to 30, 12 weeks. Missed HQ-CT and every secondary. Development stopped. | Not "almost approved." Not worth a waitlist. NCT06173531 is history. |
| Setmelanotide | Phase 2 open-label NCT06772597. 18 enrolled. ENDO 2026 poster: 17 at 6 months, mean BMI about -3.1 percent, fat about -4.2 percent, lean mass kept. Company talking Phase 3. | Not blinded. Not 200 people. Not a prescription you can ask a GP to copy from IMCIVREE's other labels. |
| Infant oxytocin | Short postnatal course. 2025 follow-up at age 3 to 4 showed better social, endocrine, and metabolic signals versus unexposed children. Safety looked acceptable in that window. | Not standard care in the US or China. Not a spray from a wellness shop. Ask only if a trial sits in your hospital. |
HOW TO READ RESULTS
In an open-label study, everyone knows they are on the drug
HQ-CT is a caregiver questionnaire. Placebo groups can also improve. That is why the carbetocin phase 3 result matters. If setmelanotide later reports phase 3 data, use the same standard. Until then, daily management is still food storage and complication prevention.