Is Risuteganib legal in Australia?

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.

Registers or lists therapeutic goods on the ARTG and schedules substances in the Poisons Standard. Many peptides are Schedule 4 (prescription only), so possession without a prescription and personal importation are restricted even when no product is registered.

The classification above is the The Longevity Archive reading of Therapeutic Goods 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.