Oclaiz (octreotide subcutaneous depot) / Camurus - LARVOL DELTA

SORENTO: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET (clinicaltrials.gov) - P3 | N=332 | Active, not recruiting | Sponsor: Camurus AB | Trial completion date: Jul 2028 ➔ Nov 2028 | Trial primary completion date: Jul 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Camurus' NDA resubmission for CAM2029 in acromegaly accepted for review by the US FDA (PRNewswire) - "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 18 December 2026."

FDA filing • PDUFA • Acromegaly

Long-Term CAM2029 Octreotide Depot Maintains Biochemical and Symptom Control in Acromegaly Across A 4-Week Dosing Interval and during Intervals >28 Days: Data from the ACROINNOVA 2 Trial (ENDO 2026) - P3 | "CAM2029 is a novel, long-acting octreotide subcutaneous depot for self-administration. CAM2029 maintained stable mean AIS Overall Scores (SD) in patients with later assessments (W48, 3.6 [3.0]; W52/EOCP, 3.7 [3.1]). Conclusion Long-term CAM2029 maintains stable disease control over a 4W dosing interval and can reduce the waning control seen with other injectable SRLs."

Acromegaly • Endocrine Disorders • IGF1 • SSTR

Long-Term Safety and Efficacy of CAM2029 in Patients with Acromegaly: Results from the ACROINNOVA 2 Open-Label Extension (ENDO 2026) - "CAM2029 is a long-acting, octreotide subcutaneous depot, recently approved in Europe and the UK. CAM2029 maintains biochemical control, sustains symptom control and enhances treatment satisfaction. When loss of control follows switch to SoC treatment, biochemical control can be regained with CAM2029."

Clinical • Acromegaly • Endocrine Disorders • IGF1

MON-038 - Long-Term CAM2029 Octreotide Depot Maintains Biochemical and Symptom Control in Acromegaly Across A 4-Week Dosing Interval and during Intervals >28 Days: Data from the ACROINNOVA 2 Trial (ENDO 2026) - P3 | "CAM2029 is a novel, long-acting octreotide subcutaneous depot for self-administration. CAM2029 maintained stable mean AIS Overall Scores (SD) in patients with later assessments (W48, 3.6 [3.0]; W52/EOCP, 3.7 [3.1]). Conclusion Long-term CAM2029 maintains stable disease control over a 4W dosing interval and can reduce the waning control seen with other injectable SRLs."

Acromegaly • Endocrine Disorders • IGF1 • SSTR

MON-036 - Long-Term Safety and Efficacy of CAM2029 in Patients with Acromegaly: Results from the ACROINNOVA 2 Open-Label Extension (ENDO 2026) - "CAM2029 is a long-acting, octreotide subcutaneous depot, recently approved in Europe and the UK. CAM2029 maintains biochemical control, sustains symptom control and enhances treatment satisfaction. When loss of control follows switch to SoC treatment, biochemical control can be regained with CAM2029."

Clinical • Acromegaly • Endocrine Disorders • IGF1

ORF28-05 - Effect of CAM2029 on Long-Term Biochemical and Symptom Control in Patients with Acromegaly and IGF-I ≤2×ULN According to Prior Injectable Somatostatin Receptor Ligand Dose: Results from ACROINNOVA 2 (ENDO 2026) - P3 | "Background Many patients with acromegaly do not achieve biochemical control (insulin‑like growth factor I [IGF-I] ≤upper limit of normal [ULN]) or symptom remission with injectable somatostatin receptor ligands (SRLs) such as octreotide long acting repeatable (LAR) and lanreotide Autogel (ATG). Conclusion CAM2029 at a standard dose of 20 mg every 4W improved both biochemical and symptom control in patients with acromegaly who had IGF-I ≤2×ULN on baseline injectable SRLs, regardless of prior SRL dose. These results support CAM2029 as an effective treatment option for acromegaly, including for patients previously escalated to high doses of octreotide LAR or lanreotide ATG."

Clinical • Acromegaly • Endocrine Disorders • IGF1 • SSTR

An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: Camurus AB | Not yet recruiting ➔ Recruiting

Enrollment open • Acromegaly • Endocrine Disorders • IGF1

Efficacy and safety of CAM2029 in patients with polycystic liver disease: phase 2b POSITANO study (EASL 2026) - P2/3 | "CAM2029 reduced total liver and liver cyst volume growth, supporting further evaluation as a potential PLD treatment. The study is ongoing to evaluate long-term CAM2029 treatment in an open-label extension period up to 120 weeks."

Clinical • P2b data • Hepatology • Pruritus

An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly (clinicaltrials.gov) - P=N/A | N=200 | Not yet recruiting | Sponsor: Camurus AB

New trial • Acromegaly • Endocrine Disorders • IGF1

What Is the Future of Acromegaly Therapy? (PubMed, J Clin Endocrinol Metab) - "Octreotide subcutaneous depot (CAM2029) maintains biochemical control with acceptable safety and may reduce treatment burden...Collectively, these agents may address unmet needs by broadening the scope of options to control production of hepatic insulin-like growth factor I (IGF-I) and to attenuate additional extrahepatic GH signaling. They may also help ease the practical burden of chronic therapy."

Journal • Acromegaly • Endocrine Disorders • IGF1 • SSTR

Camurus announces FDA acceptance of NDA resubmission for Oclaiz for the treatment of acromegaly (PRNewswire) - "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 10 June 2026...The application is supported by data from seven clinical studies, including two Phase 3 studies in the ACROINNOVA program. The updated NDA was submitted to the FDA on 10 December 2025 following a Complete Response Letter (CRL) earlier issued by the Agency, which solely related to observations during a cGMP inspection at a third-party manufacturer's facility...The product received marketing authorization in the EU and UK in 2025 under the product name Oczyesa. The product launch has recently been initiated in the EU."

EMA approval • FDA filing • Launch Europe • MHRA approval • PDUFA • Acromegaly

SORENTO: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET (clinicaltrials.gov) - P3 | N=332 | Active, not recruiting | Sponsor: Camurus AB | Trial completion date: Dec 2027 ➔ Jul 2028 | Trial primary completion date: Dec 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Neuroendocrine Tumor • Solid Tumor • SSTR

CAM2029, an Octreotide Subcutaneous Depot, Provides Long-Term and Sustained Biochemical Control of Acromegaly: Final Analysis of the Core Part of the ACROINNOVA 2 Phase 3 Trial (ENDO 2025) - P3 | "CAM2029, developed using FluidCrystal® technology, is a long-acting octreotide subcutaneous depot designed for convenient self‑administration via an autoinjector pen. In ACROINNOVA 1, a 24-week (W), Phase 3 trial (NCT04076462), CAM2029 achieved superior biochemical control vs placebo (PBO; 72.2% vs 37.5%; P=0.0018) in patients previously controlled on standard of care (SoC; octreotide long-acting repeatable [LAR]/lanreotide Autogel [ATG])...The symptom burden also progressively improved with CAM2029. These results reinforce previous findings, supporting CAM2029 as a new treatment option for acromegaly."

P3 data • Acromegaly • Dermatology • Endocrine Disorders • Infectious Disease • Novel Coronavirus Disease • IGF1

Improved Patient‑Reported Outcomes with CAM2029 Treatment, an Octreotide Subcutaneous Depot, in Patients with Acromegaly Previously on Standard-of-Care Injectable Somatostatin Receptor Ligands: Final Analysis of the Core Part of the ACROINNOVA 2 Phase 3 Trial (ENDO 2025) - P3 | "BackgroundStandard-of-care somatostatin receptor ligand therapies (SoC; octreotide long-acting repeatable/lanreotide Autogel) for acromegaly require in-office administration and can be burdensome. CAM2029, a long-acting, octreotide subcutaneous depot developed using FluidCrystal® technology, is conveniently self‑administered via autoinjector pen...Patients/partners were confident about self‑administration and highly satisfied with their experience. CAM2029 has the potential to enhance QoL and treatment satisfaction, both important unmet needs in patients with acromegaly."

Clinical • P3 data • Patient reported outcomes • Acromegaly • Endocrine Disorders • SSTR

CAM2029 Octreotide Subcutaneous Depot Maintains Control of IGF-I and Symptoms of Acromegaly Across the 4-Week Dosing Interval and During Intervals Greater Than 28 Days: Data from the ACROINNOVA 1 Trial (ENDO 2025) - P3 | "Similarly, over intervals of >28 days, CAM2029 maintained stable mean AIS overall scores across W20 (4.3), W22 (4.3) and W24/EOT (4.7) assessments.ConclusionsCAM2029 effectively maintained stable biochemical and symptom control both throughout the intended 4-week dosing interval and with extended dosing intervals. These data inform on the efficacy profile of CAM2029 when administration occurs both within and beyond a 28-day dosing window."

Acromegaly • Endocrine Disorders • IGF1 • SSTR

CAM2029 Octreotide Subcutaneous Depot Maintains Control of IGF-I and Symptoms of Acromegaly Across the 4-Week Dosing Interval and During Intervals Greater Than 28 Days: Data from the ACROINNOVA 1 Trial (ENDO 2025) - P3 | "Similarly, over intervals of >28 days, CAM2029 maintained stable mean AIS overall scores across W20 (4.3), W22 (4.3) and W24/EOT (4.7) assessments.ConclusionsCAM2029 effectively maintained stable biochemical and symptom control both throughout the intended 4-week dosing interval and with extended dosing intervals. These data inform on the efficacy profile of CAM2029 when administration occurs both within and beyond a 28-day dosing window."

Acromegaly • Endocrine Disorders • IGF1 • SSTR

SI01-01. New Horizons in Acromegaly: A Patient-Centered Case Discussion (ENDO 2025) - "This educational session will highlight the latest clinical data on CAM-2029 from the ACROINNOVA clinical trial program, offering valuable insights into the efficacy, safety, and potential clinical impact of this emerging treatment option...The session will conclude with an interactive Q&A, where audience members will have the opportunity to engage directly with the speakers. Don't miss this opportunity to gain practical, real-world insights on the evolving landscape of acromegaly treatment from two of the field's foremost experts."

Clinical • Acromegaly • Endocrine Disorders

A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly (clinicaltrials.gov) - P3 | N=135 | Completed | Sponsor: Camurus AB | Active, not recruiting ➔ Completed

Trial completion • Acromegaly • Endocrine Disorders • IGF1

Population Pharmacokinetic Analysis of an Octreotide Depot (CAM2029) in the Treatment of Acromegaly. (PubMed, Clin Pharmacokinet) - P3 | "This population PK model supports the use of CAM2029 as a potential alternative treatment option to both octreotide IR and long-acting repeatable (LAR) for acromegaly treatment. The octreotide bioavailability for CAM2029 was similar to octreotide IR and approximately 5 to 6 fold higher than octreotide LAR, with a more rapid onset."

Journal • PK/PD data • Acromegaly • CNS Disorders • Endocrine Disorders • Psychiatry • SSTR

A Patient-Centered Approach to Acromegaly: a Case Study Discussion on an Emerging Treatment sponsored by Camurus, Inc. (AACE 2025) - "This educational session will highlight the latest clinical data on CAM-2029 from the ACROINNOVA 1 & 2 clinical trial program, offering valuable insights into the efficacy, safety, and potential clinical impact of this emerging treatment option...Don't miss this opportunity to gain practical, real-world insights on the evolving landscape of acromegaly treatment from two of the field's foremost experts. To get to this product theater, enter through the Learning Zone."

Case study • Clinical • Acromegaly • Endocrine Disorders

CAM2029, a self-administered subcutaneous octreotide depot, improved PROs and symptoms in patients with acromegaly in the ACROINNOVA 2 Phase 3 trial: final analysis of the core phase results (ESPE-ESE 2025) - P3 | "CAM2029 utilises FluidCrystal® technology and provides a long-acting octreotide subcutaneous depot, self‑administered via an autoinjector pen. ACROINNOVA 1 (NCT04076462) was a Phase 3, 24-week, randomised, double-blind trial of CAM2029 in patients who are biochemically controlled (insulin-like growth factor-I [IGF-I] ≤ upper limit of normal [ULN] on standard-of-care [SoC] somatostatin receptor ligands at baseline [octreotide long-acting repeatable/lanreotide Autogel])...ACROINNOVA 2 demonstrates the combined patient benefits of convenient administration, improved QoL, treatment satisfaction and symptom control provided by CAM2029. Table: PROs/symptom burden AcroQoL and TSQM (Higher scores indicate improvement) AcroQoL (range 0–100) Total score TSQM domain scores (range 0–100) Convenience Effectiveness Global satisfaction AIS (Lower scores indicate improvement) AIS Overall score (range 0–18) CI, confidence interval."

Clinical • P3 data • Acromegaly • Endocrine Disorders • IGF1 • SSTR

CAM2029 octreotide subcutaneous depot provides stable control of IGF-I and improves key symptoms throughout a 4-week post-dose interval: analysis from the ACROINNOVA 1 trial (ESPE-ESE 2025) - P3 | "Table. Patients with symptoms of acromegaly Symptom W20* W22 W24/EOT n/Nall† (%) Fatigue 30/42 (71.4) 28/41 (68.3) 28/42 (66.7) Headache 19/42 (45.2) 16/41 (39.0) 13/42 (31.0) Joint pain 30/42 (71.4) 27/41 (65.9) 34/42 (81.0) Paraesthesia 14/42 (33.3) 12/41 (29.3) 13/42 (31.0) Soft tissue 16/42 (38.1) 13/41 (31.7) 13/42 (31.0) swelling Sweating 19/42 (45.2) 21/41 (51.2) 21/42 (50.0) *Prior to final CAM2029 administration; †Patients completing treatment with CAM2029 and attending assessment."

Acromegaly • Endocrine Disorders • Fatigue • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • IGF1 • SSTR

Results from the core phase of the open-label, Phase 3 ACROINNOVA 2 trial: CAM2029, a subcutaneous octreotide depot, achieves sustained, long-term biochemical control in acromegaly (ESPE-ESE 2025) - No abstract available

Clinical • P3 data • Acromegaly • Endocrine Disorders

Results from the core phase of the open-label, Phase 3 ACROINNOVA 2 trial: CAM2029, a subcutaneous octreotide depot, achieves sustained, long-term biochemical control in acromegaly (ESPE-ESE 2025) - P3 | "In ACROINNOVA 1, a 24-week, Phase 3 trial (NCT04076462), CAM2029 demonstrated superior biochemical control versus placebo (72.2% vs 37.5%; P=0.0018) in patients previously controlled (IGF-I ≤ upper limit of normal [ULN]) on standard-of-care somatostatin receptor ligands (SoC; octreotide long-acting repeatable/lanreotide Autogel). These long-term findings support CAM2029 as an effective new treatment for acromegaly with a safety profile consistent with SoC. Table: Proportion of patients with biochemical control Prior-placebo Prior‑CAM2029 Directly-enrolled Endpoint(s) Timepoint n/Nall* (%) IGF-I ≤ULN SoC baseline 17/18 (94.4) 33/36 (91.7) 12/81 (14.8) Placebo baseline† 5/18 (27.8) – – W50/52 mean 17/18 (94.4) 31/35 (88.6) 27/74 (36.5) IGF-I ≤ULN and GH SoC baseline 17/18 (94.4) 33/36 (91.7) 12/81 (14.8) <2.5 µg/L Placebo baseline† 5/18 (27.8) – – IGF-I: W50/52 mean 16/17 (94.1) 29/33 (87.9) 23/74 (31.1) GH: W52 mean *Patients with available data at timepoint;..."

Clinical • P3 data • Acromegaly • Dermatology • Endocrine Disorders • IGF1 • SSTR