Acromegaly is a disorder caused by chronic excess growth hormone, most commonly from a pituitary adenoma, leading to enlargement of bones and soft tissues in adults. Typical manifestations include enlarged hands and feet, facial changes, headaches, and systemic complications if untreated.
The FDA accepted Camurus' NDA resubmission for Oclaiz in acromegaly, setting a December 2026 PDUFA date. The filing follows a June 2026 Complete Response Letter related to third-party manufacturing, with no safety or efficacy issues. Oclaiz is a once-monthly subcutaneous octreotide already approved in the EU as Oczyesa.
Acromegaly patients face persistent symptoms including fatigue, joint pain, headaches, and brain fog despite biochemical control. Treatment burden and financial barriers remain significant, particularly in sub-Saharan Africa where diagnostic tools and therapies are often inaccessible.
Recent studies described structural states of human GHRHR and de novo designed GPCR exoframe modulators targeting the dopamine D1 receptor. The findings outline new approaches for allosteric GPCR modulation and precision therapeutics.
Italian pharmaceutical company Recordati reported 2025 revenues of €2.6 billion and adjusted net profit of €651.1 million, with rare disease therapies driving 29.7% growth. The company projects 2026 core earnings of €995 million to €1.03 billion, anticipating continued momentum in its specialized rare disease treatments.
Crinetics Pharmaceuticals reported over $5 million in preliminary net product revenue for PALSONIFY in Q4 2025, while Phase 2 data for its congenital adrenal hyperplasia treatment showed promising results that analysts say have derisked the Phase 3 study design.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07663318 |
A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on Pharmacokinetics Of Octreotide Acetate Tablets(T25) |
NOT_YET_RECRUITING | PHASE1 |
| NCT07659912 |
Direct Versus Video Laryngoscopy in Patients With Acromegaly |
NOT_YET_RECRUITING | |
| NCT07641179 |
A Study to Evaluate MAR002 for Acromegaly |
NOT_YET_RECRUITING | PHASE2 |
| NCT07583563 |
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly |
RECRUITING | |
| NCT07195175 |
Study of MAR002 in Healthy Men |
RECRUITING | PHASE1 |
| NCT07179926 |
Effects of Pasireotide Lar Therapy on Bone Metabolism |
RECRUITING | |
| NCT07100587 |
Ketogenic vs. Mediterranean Diet on Metabolic and Hormonal Parameters in Patients With Active Acromegaly |
COMPLETED | NA |
| NCT07037420 |
ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly |
TERMINATED | PHASE2 |
| NCT06930625 |
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs |
RECRUITING | PHASE3 |
| NCT06607666 |
Acromegaly Resistant to Conventional Dose of First Generation Somatostatin Ligands |
COMPLETED |
