Legal status · United States
Is Risuteganib legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. Risuteganib is not approved for any medical use in the United States; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 4 human studies are cited on its profile.
Risuteganib in the United States at a glance
| Classification | Investigational, not approved |
|---|---|
| FDA approval status | Not FDA approved. Phase 2 only; no phase 3 registered; most recent trial completed April 2019. |
| Human studies cited | 4 of 6 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Risuteganib profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
Risuteganib is being studied in registered clinical trials but has not received FDA marketing approval in the United States.
- 02
Lawful human access is limited to trial participation or a formal early-access scheme where one exists; there is no pharmacy product to prescribe.
- 03
Vials sold online "for research use only" are not trial material, and that label does not make human use lawful.
What Risuteganib is
An intravitreal anti-integrin peptide for dry macular degeneration and diabetic macular oedema. Six phase 2 trials in about 435 people; a 45 person dry AMD trial reported 48 percent versus 7 percent gaining 8 letters, using an asymmetric comparison. No phase 3 has been registered and the last trial completed in 2019.
Risuteganib is a synthetic peptide injected into the eye that binds several integrin heterodimers implicated in retinal oxidative stress and abnormal blood vessel growth. Allegro Ophthalmics developed it under the code ALG-1001 and the brand Luminate for diabetic macular oedema (DME) and non-exudative (dry) age-related macular degeneration, a condition with very few approved treatments.
Mechanism: In people, the mechanism has not been measured directly; the trials recorded visual acuity, and in exploratory analyses, colour vision and microperimetry. Nothing links a change in integrin signalling in a human retina to the visual acuity results.
Regulatory history: Not FDA approved. Phase 2 only; no phase 3 registered; most recent trial completed April 2019.
How FDA treats this kind of product
Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.
The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Risuteganib at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.
Risuteganib in other countries
Frequently asked questions
Is Risuteganib legal in the United States?
No. Risuteganib is not approved for any medical use in the United States; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 4 human studies are cited on its profile.
Can I buy Risuteganib in the United States?
No approved product exists to buy. In the United States Risuteganib is classified as "Investigational, not approved", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors.
Is Risuteganib FDA approved?
No. FDA status: Not FDA approved. Phase 2 only; no phase 3 registered; most recent trial completed April 2019.. Current US classification: "Investigational, not approved". On the evidence, 4 human studies are cited on its profile.
Related compounds in the United States
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Risuteganib live on its compound profile.
Risuteganib profileThis page is general information about the regulatory status of Risuteganib in the United States, current as of Sep 2026. It is not legal advice, and classifications change; check U.S. Food and Drug Administration directly or consult a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships and does not recommend where to buy anything.