Oclaiz (octreotide (subcutaneous depot))
An investigational treatment for Acromegaly.
The same compound appears under different names depending on the context. Here is how to identify Octreotide (subcutaneous depot) wherever you encounter it, plus the key facts at a glance.
- Generic name
- Octreotide (subcutaneous depot)
- Brand name
- Oclaiz
- Development code
- CAM2029
- Drug class
- Somatostatin analog (long-acting depot)
- Manufacturer
- Camurus
- How it's taken
- A once-monthly subcutaneous injection using a pre-filled autoinjector pen, designed for self-administration at home after training.
A monthly, self-administered octreotide injection from Camurus designed to replace clinic-administered intramuscular depots. Already approved in the EU and UK (as Oczyesa), it is under FDA review in the U.S. with a target decision date of December 18, 2026.
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Where Octreotide (subcutaneous depot) fits
Aims to control the disease with a thin-needle autoinjector pen patients can use themselves at home, instead of monthly clinic visits for deep intramuscular injections. No trial has compared it directly with Sandostatin LAR. It would compete with Sandostatin LAR and Somatuline Depot as a maintenance option.
How Octreotide (subcutaneous depot) works
Octreotide is a lab-made copy of somatostatin, the body's natural brake on growth hormone. Like the injectable octreotide used for decades, CAM2029 binds somatostatin receptors on the pituitary tumor and suppresses growth hormone release, lowering IGF-1.
What is different is the delivery. Camurus' FluidCrystal technology turns the drug into a small-volume liquid that forms a slow-release gel depot under the skin, releasing octreotide over a full month. The formulation has about 5 times the bioavailability of the standard long-acting intramuscular octreotide, and comes in a pre-filled autoinjector pen with a thin, hidden needle that patients can use themselves[2][5].
Mechanism: 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
Side effects and safety
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. Full U.S. prescribing information will come with the FDA label if approved[5][2].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Octreotide (subcutaneous depot)
A once-monthly subcutaneous injection using a pre-filled autoinjector pen, designed for self-administration at home after training. This contrasts with Sandostatin LAR, which requires a deep intramuscular injection given by a healthcare professional[2].
Clinical trial results
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[5].
The FDA first declined the U.S. application in October 2024 over findings at a third-party manufacturing site[4]. Camurus resubmitted on December 10, 2025, and the FDA set a June 10, 2026 decision date[3]. On that date it issued a second Complete Response Letter, tied to observations from the site's September 2024 inspection plus a labeling request about the oxygen absorber in the packaging, not to the drug's efficacy or safety. Camurus resubmitted again, the FDA accepted that resubmission on July 17, 2026, and the new target decision (PDUFA) date is December 18, 2026[1][2].
Main registered trial: NCT04076462 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Development history
CAM2029 was developed by Swedish company Camurus, whose FluidCrystal depot platform is also used in other long-acting medicines. The acromegaly program spans 7 clinical trials, including the 2 Phase 3 ACROINNOVA studies. The product received EU and UK marketing authorization under the name Oczyesa, and Oclaiz is its proposed U.S. brand name, while the U.S. application works through the manufacturing-facility issues raised in the June 2026 Complete Response Letter[1][2].
Explore Acromegaly trials
Other Acromegaly treatments
Acromegaly maintenance therapy is rapidly diversifying: Palsonify (paltusotine, approved September 2025) established the first once-daily oral option, Mycapssa offers oral octreotide for patients controlled on injectables, and CAM2029 targets the large group of patients who stay on long-acting injections but want to self-administer at home rather than visit a clinic monthly. Debio 4126, a long-acting octreotide in Phase 3, aims at even longer dosing intervals.
Octreotide (subcutaneous depot) in Trial Friend News and Guides
Common questions about Octreotide (subcutaneous depot)
▸What is Octreotide (subcutaneous depot) (Oclaiz)?
A monthly, self-administered octreotide injection from Camurus designed to replace clinic-administered intramuscular depots. Already approved in the EU and UK (as Oczyesa), it is under FDA review in the U.S. with a target decision date of December 18, 2026.
▸How does Octreotide (subcutaneous depot) work?
Octreotide is a lab-made copy of somatostatin, the body's natural brake on growth hormone. Like the injectable octreotide used for decades, CAM2029 binds somatostatin receptors on the pituitary tumor and suppresses growth hormone release, lowering IGF-1.
What is different is the delivery. Camurus' FluidCrystal technology turns the drug into a small-volume liquid that forms a slow-release gel depot under the skin, releasing octreotide over a full month. The formulation has about 5 times the bioavailability of the standard long-acting intramuscular octreotide, and comes in a pre-filled autoinjector pen with a thin, hidden needle that patients can use themselves[2][5].
▸What are the side effects of Octreotide (subcutaneous depot)?
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. Full U.S. prescribing information will come with the FDA label if approved[5][2].
▸How is Octreotide (subcutaneous depot) taken?
A once-monthly subcutaneous injection using a pre-filled autoinjector pen, designed for self-administration at home after training. This contrasts with Sandostatin LAR, which requires a deep intramuscular injection given by a healthcare professional[2].
▸Is Octreotide (subcutaneous depot) FDA approved?
Not yet. Octreotide (subcutaneous depot) is under FDA review for Acromegaly; Camurus has filed an application and a decision is due December 18, 2026. The FDA calendar page tracks the outcome.
▸Is Oclaiz (CAM2029) FDA approved?
No. Oclaiz (CAM2029), Camurus' monthly octreotide subcutaneous depot, is not FDA-approved; it has completed Phase 3 trials and is under FDA review with a target decision date of December 18, 2026. In June 2026 the FDA issued a Complete Response Letter related to observations at a third-party manufacturing facility and a labeling request about the oxygen absorber in the packaging, not to the drug's efficacy or safety, and the FDA accepted Camurus' resubmission in July 2026. The same product is already approved in the EU and UK under the name Oczyesa. The June 2026 letter was the second, after a first in October 2024 over the same manufacturing site. [4][1][2]
▸How is Oclaiz given?
Oclaiz is a once-monthly injection under the skin using a pre-filled autoinjector pen with a thin, hidden needle, designed for patients to give themselves at home after training. Camurus' FluidCrystal technology turns octreotide into a small-volume liquid that forms a slow-release gel depot under the skin and releases the drug over a full month. This contrasts with Sandostatin LAR, which requires a deep intramuscular injection given by a healthcare professional. [5][2]
▸What did the Oclaiz ACROINNOVA trials show?
In the Phase 3 ACROINNOVA 1 study, significantly more patients with acromegaly on Oclaiz (CAM2029) achieved normalized IGF-1 levels than on placebo. The open-label ACROINNOVA 2 study confirmed that IGF-1 control and symptom reduction persisted over 52 weeks. Across the ACROINNOVA program, safety was consistent with the known octreotide profile. [5][2]
▸What are the side effects of Oclaiz?
Because Oclaiz delivers octreotide, its side effects mirror other somatostatin analogs: gastrointestinal symptoms such as diarrhea, nausea and 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. Full U.S. prescribing information will come with the FDA label if Oclaiz is approved. [5][2]
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Camurus AB · June 2026. Camurus provides regulatory update on the US NDA for CAM2029 (Oclaiz) in acromegaly. https://www.camurus.com/media/press-releases/2026/camurus-provides-regulatory-update-on-the-us-nda-for-cam2029-oclaiz-in-acromegaly/
- Camurus AB · 2026-07-17. Camurus' NDA resubmission for CAM2029 in acromegaly accepted for review by the US FDA (PDUFA December 18, 2026). https://www.camurus.com/media/press-releases/2026/camurus-nda-resubmission-for-cam2029-in-acromegaly-accepted-for-review-by-the-us-fda/
- Camurus AB · 2026-01-09. Camurus announces FDA acceptance of NDA resubmission for Oclaiz for the treatment of acromegaly. https://mfn.se/all/a/camurus/camurus-ab-camurus-announces-fda-acceptance-of-nda-resubmission-for-oclaiz-for-the-treatment-of-acromegaly-fbdb1dad
- Camurus AB · October 2024. Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly. https://www.camurus.com/media/press-releases/2024/camurus-provides-regulatory-update-on-the-us-nda-for-cam2029-in-acromegaly/
- Camurus AB · July 2025. Camurus' Oczyesa receives marketing authorization for treatment of acromegaly in the EU. https://www.camurus.com/media/press-releases/2025/camurus-oczyesa-receives-marketing-authorization-for-treatment-of-acromegaly-in-the-eu/