Oclaiz (octreotide subcutaneous depot) / Camurus - LARVOL DELTA

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

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

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

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, 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

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

CHMP recommends approval of Oczyesa for treatment of acromegaly in the EU (PRNewswire) - "Camurus...announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for market authorization of Oczyesa, octreotide subcutaneous depot (CAM2029), for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues...The CHMP positive opinion is backed by a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies. The ACROINNOVA 1 study demonstrated that treatment with Oczyesa results in a significantly higher proportion of patients achieving normalized insulin growth-factor-1 (IGF-1) levels compared to placebo. The persistence of mean IGF-1 values and reduction of symptoms were confirmed over 52 weeks in the ACROINNOVA 2 study....A final decision on the marketing authorization of Oczyesa based on the CHMP recommendation is anticipated from the European Commission in mid-2025."

CHMP • EMA approval • Acromegaly

"Cold" Somatostatin Analogs in Neuroendocrine Neoplasms: Decoding Mechanisms, Overcoming Resistance, and Shaping the Future of Therapy. (PubMed, Cells) - "This paper provides a comprehensive analysis of the cellular and molecular mechanisms of SSAs. SSAs remain integral to the management of NENs, providing effective tumor stabilization and symptom control. However, resistance mechanisms and tumor heterogeneity necessitate innovative approaches, including high-dose regimens, combination strategies, and next-generation formulations. Future research should focus on refining these strategies to optimize patient outcomes, enhance long-term efficacy, and expand the therapeutic landscape for NENs."

Journal • Review • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

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 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

The current status of somatostatin analogs in the treatment of neuroendocrine tumors and future perspectives. (PubMed, Expert Rev Neurother) - "Perspectives on emerging nonpeptide SSAs such as paltusotine and innovative formulations of octreotide (CAM2029) are included. Octreotide and lanreotide appear to be clinically interchangeable, and no signs of superiority of one agent over the other has been observed so far. Whether SSAs may be exploited in the maintenance setting following more aggressive treatments, whether continuing SSAs beyond-progression after first-line therapy could be an effective treatment strategy, and whether new-generation SSAs such as pasireotide could overcome resistance to established SSAs are key areas of investigation."

Journal • Review • Carcinoid Tumor • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Octreotide subcutaneous depot for acromegaly: A randomized, double-blind, placebo-controlled phase 3 trial, ACROINNOVA 1. (PubMed, J Clin Endocrinol Metab) - P3 | "CAM2029 provides a convenient and effective treatment option for acromegaly, with superior biochemical control versus placebo. Symptom control, QoL and satisfaction were improved from baseline SoC."

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

POSITANO: A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD (clinicaltrials.gov) - P2/3 | N=71 | Active, not recruiting | Sponsor: Camurus AB | Trial completion date: Aug 2025 ➔ Aug 2027

Trial completion date • Hepatology

A Randomized Phase 3 Trial to Assess Efficacy and Safety of a Novel Formulation of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly (AACE 2024) - P3 | "Methods In this Phase 3, multinational, randomized, double-blind, placebo-controlled trial (NCT04076462), patients on stable SoC treatment (octreotide LAR or lanreotide Autogel) who had IGF-1 ≤1x upper limit of normal (ULN) at screening were randomized 2:1 to once-monthly CAM2029 20 mg or placebo for 24 weeks. Discussion/Conclusion CAM2029 provided robust biochemical control of acromegaly superior to placebo, substantially improved PROs vs baseline SoC and placebo, and had a safety profile consistent with SoC. These findings support CAM2029 as a potential therapeutic alternative to SoC acromegaly treatments that addresses unmet patient needs."

Clinical • P3 data • Acromegaly • CNS Disorders • Dermatology • Endocrine Disorders • Gastroenterology • Hepatology • Migraine • Pain • IGF1

CAM2029, Octreotide Subcutaneous Depot, Improves Patient-Reported Outcomes From Standard-of-Care Baseline in Patients With Acromegaly: Interim Results From a Phase 3 Study (ACROINNOVA 2) (ENDO 2024) - P3 | "In a 24-week Phase 3 trial (ACROINNOVA 1), CAM2029 achieved superior insulin-like growth factor 1 (IGF-1) response vs placebo in acromegaly patients (pts) previously controlled with SoC (octreotide LAR/lanreotide Autogel). Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Clinical • P3 data • P3 data: top line • Patient reported outcomes • Acromegaly • Endocrine Disorders • Fatigue • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • IGF1

Efficacy and Safety of CAM2029 in Patients With Controlled or Inadequately Controlled Acromegaly on Standard-of-Care Treatment: Interim Data for the "New to CAM2029" Patient Subgroup in a Phase 3 Study (ACROINNOVA 2) (ENDO 2024) - P3 | "Here, we report interim data from another Phase 3 trial of CAM2029 (ACROINNOVA 2; NCT04125836), focusing on the "New to CAM2029" subgroup of patients whose acromegaly was either controlled or uncontrolled under SoC.MethodsThis 52-week, Phase 3, open-label trial (with a 52-week extension) enrolled patients who had received CAM2029 or placebo in ACROINNOVA 1 (reported separately) and "New to CAM2029" patients who were adequately or inadequately controlled (IGF-1 ≤2x ULN) on a stable dose of octreotide LAR/lanreotide Autogel for ≥3 months (data reported here). Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Clinical • P3 data • P3 data: top line • Acromegaly • Dermatology • Endocrine Disorders • Pain • IGF1

CAM2029, Octreotide Subcutaneous Depot, Provides Sustained Biochemical Control of Acromegaly: Interim Results From a Phase 3 Study (ACROINNOVA 2) (ENDO 2024) - P3 | "In a 24-week Phase 3 trial (ACROINNOVA 1, NCT04076462), CAM2029 achieved superior IGF-1 control vs placebo (IGF-1 ≤ upper limit of normal [ULN]: 72.2 vs 37.5%; P=0.0018) in acromegaly patients previously controlled with standard-of-care (SoC; octreotide long-acting repeatable/lanreotide Autogel). Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

P3 data • P3 data: top line • Acromegaly • Endocrine Disorders • Gastroenterology • IGF1

A RANDOMIZED PHASE 3 TRIAL TO ASSESS EFFICACY AND SAFETY OF A NOVEL FORMULATION OF OCTREOTIDE SUBCUTANEOUS DEPOT IN PATIENTS WITH ACROMEGALY (ICE-EDEC 2024) - P3 | " In this phase 3, multinational, randomized, double-blind, placebo-controlled trial (NCT04076462), patients on stable treatment with octreotide LAR or lanreotide autogel, and with normal IGF-1 levels at screening, were randomized 2:1 to once-monthly CAM2029 20 mg or placebo for 24 weeks. CAM2029 treatment resulted in robust biochemical control superior to placebo, substantially improved PROs compared to baseline SoC and placebo, and a safety profile consistent with SoC somatostatin receptor ligand treatments, demonstrating the potential of CAM2029 as an alternative to SoC acromegaly treatments that addresses unmet patient needs."

Clinical • P3 data • Acromegaly • CNS Disorders • Dermatology • Endocrine Disorders • Gastroenterology • Hepatology • Migraine • Pain • IGF1 • SSTR

POSITANO: A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD (clinicaltrials.gov) - P2/3 | N=71 | Active, not recruiting | Sponsor: Camurus AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology

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 | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR