Oclaiz (octreotide subcutaneous depot) for Acromegaly
The FDA is expected to decide on Oclaiz for Acromegaly by December 18, 2026, under a NDA resubmission from Camurus.
What is being decided
Camurus has a NDA resubmission under FDA review for Oclaiz (octreotide subcutaneous depot) in Acromegaly. Resubmitted after a June 2026 complete response letter; would be the first self-administered long-acting octreotide.
Who this decision matters to
Acromegaly is a rare hormonal disorder caused by excessive growth hormone production, typically from a pituitary adenoma, resulting in abnormal growth of hands, feet, and facial features. It also causes serious health complications including heart disease, diabetes, arthritis, and increased cancer risk. Symptoms develop gradually over years.
Prevalence: Approximately 50-130 cases per million people; estimated 25,000-30,000 people in the United States with about 3,000 new cases diagnosed per year. See our full Acromegaly page for current treatments, recruiting trials, and community resources.
About the drug
Oclaiz long-acting somatostatin analog (somatostatin receptor 2 and 5 agonist) delivered as a monthly subcutaneous depot using FluidCrystal technology, enabling self-administration with an autoinjector pen Our full Oclaiz profile covers how it works, side effects in plain language, and its trial history.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Where Acromegaly treatment stands today
Acromegaly treatment is in the middle of a shift away from injection-only care. Palsonify (paltusotine), approved by the FDA in September 2025, is the first once-daily oral treatment for adults with acromegaly, and Mycapssa (oral octreotide capsules) offers an oral maintenance option for patients already controlled on injectable somatostatin analogs. Another convenience-focused option, Oclaiz (octreotide subcutaneous depot, CAM2029) — a monthly self-administered injection already approved in the EU and UK — is under FDA review with a target decision date of December 18, 2026. In active clinical trials, a long-acting octreotide formulation (Debio 4126) is recruiting in Phase 3 for patients previously treated with somatostatin analogs. Surgery (transsphenoidal resection) remains first-line treatment when the tumor is accessible, with stereotactic radiation for tumors that persist after surgery. Beyond hormone control, managing cardiovascular complications, sleep apnea, metabolic changes, and joint disease is equally important. Consulting an endocrinologist experienced in pituitary disorders ensures coordinated management of both the growth hormone excess and its systemic effects.
Meanwhile, 17 Acromegaly trials are recruiting
Whatever the FDA decides here, research on Acromegaly does not stop. A few currently enrolling studies, US sites first:
Other drugs Trial Friend tracks for Acromegaly
Get notified when new acromegaly trials open or existing trials change status, add sites, or update eligibility.
Our coverage
Frequently asked questions
When will the FDA decide on Oclaiz?
The FDA's target decision date (PDUFA date) for Oclaiz in Acromegaly is December 18, 2026, disclosed by Camurus. The agency can act before this date and occasionally runs past it.
What is Oclaiz being reviewed for?
Camurus submitted a NDA resubmission for Oclaiz in Acromegaly. Resubmitted after a June 2026 complete response letter; would be the first self-administered long-acting octreotide.
What happens after the Oclaiz decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Camurus press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified weekly.