The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 10 June 2026 for Acromegaly.
Lund, Sweden — 9 January 2026 — Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission of the New Drug Application (NDA) for Oclaiz™ (CAM2029), octreotide extended-release injection, for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 10 June 2026.
Note: CAM2029 received a temporary FDA setback in acromegaly because of manufacturing‑facility quality issues, not because of problems with the drug itself. The company reports that its GEP‑NET trial programme (SORENTO) is continuing. However, all future approvals—including for NETs—will depend on the same manufacturing standards being fully resolved and accepted by regulators.”
Oczyesa for treatment of acromegaly is approved for use in the EU and UK
Lund, Sweden — 28 August 2025 — Camurus (NASDAQ STO: CAMX) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Oczyesa®, octreotide subcutaneous depot, marketing authorization for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogs.1
”Oczyesa, the first once-monthly subcutaneous octreotide treatment, has shown effective and sustained control of acromegaly and can be self-administered by patients using an autoinjector pen”, says Fredrik Tiberg, President & CEO, CSO at Camurus. ”Camurus plans to launch the treatment in the UK in the fourth quarter of 2025.”
The MHRA’s marketing authorization of Oczyesa is based on the results from a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies within the ACROINNOVA program.
Oczyesa is formulated using Camurus’ proprietary FluidCrystal® technology. The product is designed for convenient once-monthly, subcutaneous self-administration using a pre-filled autoinjector pen with a hidden, thin needle.
Oczyesa was granted marketing authorization in the EU by the European Commission on 30 June 2025.
Read more – click here for UK approval
Read more – click here for EU approval
Camurus announces completed enrolment in the Phase 3 SORENTO study of CAM2029 in patients with neuroendocrine tumours
December 14, 2023 at 02:01 am EST Lund, Sweden – 14 December 2023 – Camurus (NASDAQ STO: CAMX) today announces completed enrolment in the randomized, active-controlled Phase 3 SORENTO study evaluating the efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with neuroendocrine tumours located in the gastrointestinal tract or pancreas (GEP-NET). “The enrolment of patients in SORENTO has exceeded expectations. Going forward, we will continue to collect data for the primary endpoint assessment of superiority in progression-free survival with CAM2029 compared to current standard medical therapies with first-generation somatostatin receptor ligands”, says Fredrik Tiberg, Camurus’ President & CEO, CSO. “We are deeply grateful to study participants and clinical investigators for their contributions to this important milestone and look forward to study results when the target number of progression events in SORENTO has been reached.”
The SORENTO study enrolment has exceeded the target of 302 randomized participants across 103 clinical sites in 12 countries in North America, Europe, Asia and Australia. The primary endpoint is to demonstrate statistically significant increased progression-free survival of treatment with CAM2029 compared to standard of care in patients with metastatic, unresectable GEP-NET. Topline study results will be read out after 194 confirmed tumour progression events or deaths.
“SORENTO is the largest randomized clinical study of a somatostatin receptor ligand in GEP-NET performed to date. The rapid rate of patient enrolment reflects a high interest in CAM2029 and the SORENTO study within the global NET treating community”, says coordinating investigator for the study Dr Simron Singh, Medical oncologist at the Susan Leslie Clinic for neuroendocrine cancers, Odette Cancer Center, Sunnybrook Health Sciences center, Toronto, Canada, associate professor at the University of Toronto. “Alongside assessment of the primary endpoint of significantly improved Tumor control, self-administration of CAM2029 is evaluated in SORENTO as part of the global movement to increase patient empowerment and patient centered care.”
Original Blog
This clinical trial caught my eye. A version of octreotide long-acting which is prefilled and given subcutaneously. Plus, the manufacturers say it has a much higher bioavailability than the standard product Sandostatin LAR (bioavailability is the proportion of a drug or other substance which enters the circulation when introduced into the body and so is able to have an active effect)
CAM2029 might therefore be considered a generic of Sandostatin LAR but better both in the delivery system and bioavailability.
What is CAM2029?
CAM2029 is developed for the treatment of acromegaly and neuroendocrine tumors. The product candidate offers important potential advantages over currently marketed products, including easy administration, significantly increased bioavailability, and potential for enhanced treatment efficacy in patients for whom current treatments provide suboptimal treatment effects.
CAM2029 is a ready-to-use, long-acting subcutaneous injection depot based on the active substance octreotide formulated with Camurus’ proprietary FluidCrystal® injection depot technology. It is provided as a prefilled syringe, thus not requiring any reconstitution or conditioning prior to administration. Due to the superior ease of handling and administration, CAM2029 can be conveniently administered by the patients themselves.
CAM2029 – Key target attributes
• Subcutaneous long-acting octreotide
• Fast onset and one month duration of therapeutic plasma-levels
• Provided ready-for-use in prefilled syringes for easy self-administration
• Compatible with autoinjectors
• High bioavailability – 500% higher than Sandostatin® LAR®, with potential for better treatment effects in some patients
CAM2029 – Key publications
1. Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: a phase 2, multicenter study
Pavel M, Borson‑Chazot F, Cailleux A, Hörsch D, Lahner H, Pivonello R, Tauchmanova L, Darstein C, Olsson H, Tiberg F, Ferone D., Cancer Chemotherapy and Pharmacology (2019) 83:375–385
2. Camurus announces dosing initiated in Phase 3 study of CAM2029 in patients with Neuroendocrine Tumors.
The Sorento Clinical Trial
Purpose: The purpose of this study is to compare the effectiveness and safety of CAM2029 to both Octreotide LAR (Sandostatin LAR) or Lanreotide Autogel in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
Who can take part? Make sure you read all of the inclusion and exclusion details in the clinical trial. I picked out a key one for each. Included – Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin. Excluded – Previously received radioligand therapy (PRRT) at any time.
Where are the trials taking place? United States, Europe and Australia. The principal investigator is well-known Canadian NET specialist Simron Singh MD. They are looking for 300 participants across all sites. Recruiting now according to the clinical trials document.
Great video of FluidCrystal® injection depot from the manufacturer but it’s not clear whether any authorised drug delivery system would look like this, it could be a prototype and/or just for clinical trial use.
The Clinical Trial Document for Sorento CAM2029
The full clinical trial document can be found here or click on the picture.
Due completion Dec 2026. Trial locations across North America/Europe and Australia
This oral Somatostatin Analogue clinical study may also be of interest
Click here or click on the picture.
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Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.
General Clinical Trials Disclaimer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
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Hi Ronnie
Have you ever hd a break from your injections?
No, 144 tomorrow for me.
Thank you Ronny. Always on the cutting edge to bring important information to our Neuroendocrine Community!
someone has to be!
Hi Ronnie, have you ever had a break from you injections?
No, tomorrow is 144th