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DEC 18 2026
UPCOMING · 80 DAYS TO PDUFA

Camurus — Oclaiz (octreotide) $CAMX

for acromegaly

NDA · Standard Review

Accepted JUL 17 2026.

About

Acromegaly is a disorder in which the body keeps making too much growth hormone after the bones have stopped growing, causing hands, feet, and facial features to enlarge and leading to joint pain, headaches, vision problems, and complications like diabetes and sleep apnea. Oclaiz is a long-acting form of octreotide, a lab-made version of the hormone somatostatin, delivered by monthly injection under the skin to block growth hormone release. Because acromegaly is driven by excess growth hormone, calming that signal at its source may help control symptoms and reduce the strain the disease puts on the body over time.

Pivotal trial

NCT00616551 Phase 3 completed NCT00616551

The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.

Source: ClinicalTrials.gov

Also in development