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DEC 18 2026
UPCOMING · 140 DAYS TO PDUFA

Camurus Oclaiz (octreotide) $CAMX

for acromegaly

NDA · Standard Review

Accepted JUL 17 2026.

About

Acromegaly is a disorder caused by too much growth hormone in adults, leading to enlarged hands, feet, and facial features, along with joint pain, headaches, and risks like diabetes and high blood pressure. Oclaiz is a long-acting, injectable form of octreotide, a drug that mimics a natural hormone to block the release of excess growth hormone. By providing a monthly, self-administered injection, this treatment could offer a more convenient way to manage hormone levels and the symptoms of this condition.

Pivotal trial

NCT00128232 Phase 3 completed NCT00128232

Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled

Source: ClinicalTrials.gov

Also in development