MYCAPSSA (octreotide acetate)
Mycapssa is used for the long-term maintenance of patients with acromegaly. It helps patients who have already shown a positive response to and can tolerate other treatments like octreotide or lanreotide. This medication provides a way to manage the condition over an extended period for those who have successfully used similar therapies in the past.
How MYCAPSSA Works
This drug works by mimicking the actions of somatostatin, a natural hormone, but with greater potency in inhibiting growth hormone, glucagon, and insulin. When it binds to its targets, it suppresses various hormonal responses and reduces splanchnic blood flow. These actions help manage the condition by inhibiting the release of several peptides and hormones like serotonin and gastrin.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-06-26
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
MYCAPSSA Approval History
What MYCAPSSA Treats
1 indicationsMYCAPSSA is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acromegaly
MYCAPSSA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MYCAPSSA
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
38 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05477576 ACTION-1 | RYZ101-301 | Ph 3 | recruiting | Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy |
| NCT03879694 | I 79518 NCI-2019-00827, I 79518 | Ph 1 | completed | Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors |
| NCT06558422 | AAAU9702 P30DK063608, K12DK133995 | Ph 1 | not yet recruiting | Human Models of Selective Insulin Resistance: Pancreatic Clamp |
| NCT06865677 results posted | 10002068 002068-C | Ph 2 | terminated | Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas |
| NCT05724134 | AAAU3014 3P30DK063608 | Ph 1 | completed | Pancreatic Clamp in NAFLD |
| NCT03624517 LOVARB results posted | Pro00027015 | Ph 4 | terminated | Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices |
| NCT03000946 PREFIPS | P150915 2016-001673-32 | Ph 3 | completed | Prevention of Postoperative Pancreatic Fistula by Somatostatin |
| NCT03289741 results posted | 17-422 | Ph 4 | completed | A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide |
| NCT02457156 PANasta | UoL000732 | Ph 3 | completed | Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy |
| NCT06126354 | AAAU7680 3P30DK063608 | Ph 1 | withdrawn | Dexamethasone/Pancreatic Clamp P&F |
| NCT04048707 ANTHEM | #19-005718 | Ph 2 | withdrawn | Angiotensin 2 for Hepatorenal Syndrome |
| NCT03179995 results posted | 17-1024 GI-072 | Ph 2 | terminated | Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy |
| NCT00427349 results posted | CDR0000526256 ECOG-E4206, U10CA023318 | Ph 2 | completed | AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors |
| NCT02333565 CEVOREM | 2014-09 2014-003694-42, RCAPHM14_0080 | Ph 2 | completed | Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas |
| NCT02384122 OCEAN | NLOCEAN.50514.091.14 | Ph 3 | completed | Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias |
| NCT04027348 results posted | I 74018 | Ph 2 | terminated | Palliative Management of Inoperable Malignant Bowel Obstruction |
| NCT01229943 results posted | NCI-2011-02609 NCI-2011-02609, CDR0000687459 | Ph 2 | completed | Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery |
| NCT02916433 results posted | 16-1101 | Ph 2 | completed | Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients |
| NCT04129255 CSMS99 | IMMUNeOCT | Ph 2 | completed | Octreotide LAR in the Induction of Immunologic Response in NENs Patients |
| NCT02032784 | 541923 | Ph 4 | terminated | Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding |
| NCT02294786 results posted | 117314 | Ph 2 | terminated | Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer |
| NCT03571594 | ONO-5788-01 | Ph 1 | terminated | A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers |
| NCT01587222 | MAFRI-II | Ph 2 | withdrawn | Midodrine, Octreotide and Albumin: Impact on Renal Function of Patients With Liver Cirrhosis and Renal Failure |
| NCT02237053 GLEE | TRIMDFH 601205 | Ph 1 | completed | Effects of Glucagon Administration on Energy Expenditure |
| NCT02217800 results posted | DG3173-II-02 | Ph 2 | completed | The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics |
| NCT02235987 results posted | DG3173-II-01 | Ph 2 | completed | Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients. |
| NCT00600886 results posted | CSOM230C2305 2007-001972-36 | Ph 3 | completed | Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly |
| NCT02195635 | LX1606.1-109-NRM LX1606.109 | Ph 1 | completed | Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects |
| NCT01204476 | NCI-2010-02196 NCI-2010-02196, CDR0000685267 | Ph 1 | completed | Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma |
| NCT02111044 POC | DSC/13/2984/05 | Ph 2 | completed | Phase II Study With ITF2984 in Acromegalic Patients |
| NCT02119884 HEofT&O | CSY-LB-2014 | Ph 4 | completed | Hemodynamic Effects of Terlipressin and High Dose Octreotide |
| NCT01917773 results posted | 1305011397 | Ph 4 | completed | Effect of Octreotide on the Colonic Motility in Pediatric Patients |
| NCT01469338 | 4P-11-3 NCI-2011-03266 | Ph 2 | terminated | Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel |
| NCT02217839 | DG3173-I-002 | Ph 1 | completed | Multiple Ascending Dose Tolerability, Pharmacokinetic and Pharmacodynamic Study of DG3173 |
| NCT00884715 | IP107-002 | Ph 1, Ph 2 | terminated | Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome |
| NCT01295060 | EN3332-301 | Ph 3 | terminated | Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly |
| NCT00690430 results posted | CSOM230C2303 2007-000739-25 | Ph 3 | completed | Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease |
| NCT01561066 | BRA2011232-1 | Ph 1 | completed | Autologous Fibrin Glues for Fistulas Closure |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MYCAPSSA FDA Label Details
Indications & Usage
FDA Label (PDF)MYCAPSSA is indicated for the treatment of Acromegaly.
MYCAPSSA Patents & Exclusivity
Patents (16 active)
Exclusivity
Pro Intelligence Preview
Deep insights for MYCAPSSA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 16 active patents
Trial Analysis
- • 29 total trials
- • Stage: Declining
Competitive Landscape
- • 10 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment