Oclaiz (octreotide subcutaneous depot) for Acromegaly
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The FDA is expected to decide on Oclaiz for Acromegaly by December 18, 2026, under an NDA resubmission from Camurus.
What is being decided
Camurus has an NDA resubmission under FDA review for Oclaiz (octreotide subcutaneous depot) in Acromegaly. Resubmitted after a June 10, 2026 complete response letter, the second for this application, which cited findings from an inspection at a third-party manufacturing site and raised no efficacy or safety concerns. The FDA accepted the resubmission on July 17, 2026. Would be the first self-administered long-acting octreotide in the US; already approved in the EU as Oczyesa.
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
Read our full Acromegaly treatment summary
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.
The Acromegaly page has every treatment and trial →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:
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Acromegaly. Unsubscribe anytime.
Our coverage
Frequently asked questions
When will the FDA decide on Oclaiz?
The FDA's target date (PDUFA date) for Oclaiz in Acromegaly is December 18, 2026.
Who disclosed it: Camurus. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Camurus press release
What is Oclaiz being reviewed for?
Camurus submitted an NDA resubmission for Oclaiz in Acromegaly.
What to know: Resubmitted after a June 10, 2026 complete response letter, the second for this application, which cited findings from an inspection at a third-party manufacturing site and raised no efficacy or safety concerns. The FDA accepted the resubmission on July 17, 2026. Would be the first self-administered long-acting octreotide in the US; already approved in the EU as Oczyesa.
How it works: 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.
More: the Oclaiz drug page explains it in plain language.
Is there already an FDA-approved treatment for Acromegaly?
Yes. Trial Friend's drug list includes 6 FDA-approved drugs for Acromegaly.
Approved: Sandostatin (octreotide), Somavert (pegvisomant), Somatuline Depot (lanreotide), Signifor (pasireotide), Mycapssa (octreotide), Palsonify (paltusotine).
Check: the Acromegaly page also searches FDA drug labels for approved treatments.
What did the Oclaiz trials show?
The Phase 3 ACROINNOVA 1 study showed that significantly more patients on CAM2029 achieved normalized IGF-1 levels than on placebo, and the open-label ACROINNOVA 2 study confirmed that IGF-1 control and symptom reduction persisted over 52 weeks.
More: the Oclaiz drug page has the full trial history and sources.
What are the side effects of Oclaiz?
Because it delivers octreotide, the side-effect profile mirrors other somatostatin analogs: gastrointestinal symptoms (diarrhea, nausea, abdominal discomfort), gallstones with long-term use, blood sugar changes, and injection-site reactions. In the Phase 3 ACROINNOVA program, safety was consistent with the known octreotide profile.
More: the Oclaiz drug page lists the warnings in full.
Can I get Oclaiz before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 17 Acromegaly trials are recruiting now. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Camurus directly. Registered programs are listed on ClinicalTrials.gov.
How much will Oclaiz cost?
Camurus has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Oclaiz decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
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 daily.