Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pasireotide sub-cutaneous · 1 trial · 1 indication
Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.
| Arm | Type | Description |
|---|---|---|
| Pasireotide 600 μg | EXPERIMENTAL | Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day. |
| Pasireotide 900 μg | EXPERIMENTAL | Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day |
| Name | Type | Description |
|---|---|---|
| Pasireotide sub-cutaneous | DRUG | Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg, 600 μg, or 300 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg and 600 μg for glucose impaired metabolism patients |
Inclusion criteria: 1. Written informed consent obtained prior to any screening procedures 2. Male or female patients aged 18 years or greater 3. Patients with confirmed diagnosis of Cushing's disease as evidenced by mean urinary free cortisol of three 24-hour urine samples collected during the 3-w...
Pasireotide sub-cutaneous is an investigational small molecule being studied for Cushing's Disease and for metastatic melanoma and Merkel cell carcinoma. It is developed by Novartis AG and is in clinical development, with completed trials in these indications.
Pasireotide sub-cutaneous is a somatostatin analog that targets somatostatin receptors. It is being studied for its effects in endocrine conditions like Cushing's Disease and in certain cancers, though specific receptor subtypes are not detailed here.
Pasireotide sub-cutaneous is developed by Novartis AG, a pharmaceutical company listed on the stock exchange under the ticker NVS. The drug is being investigated for Cushing's Disease and for metastatic melanoma and Merkel cell carcinoma.
Pasireotide sub-cutaneous has completed a Phase 3 trial for Cushing's Disease and a Phase 1 trial for metastatic melanoma and Merkel cell carcinoma. It is not approved and remains investigational, with no active trials currently listed.
Pasireotide sub-cutaneous has been studied in two completed trials. NCT01582061 was a Phase 3 expanded access study in Cushing's Disease with 104 participants. NCT01652547 was a Phase 1 dose escalation study in metastatic melanoma and Merkel cell carcinoma with 10 participants.
Pasireotide sub-cutaneous is a formulation of pasireotide, also known as SOM230. The sub-cutaneous version is administered by injection under the skin, and it is being studied for Cushing's Disease and certain cancers.