Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Stabilized Isoamyl Nitrite (SIAN)
Stabilized Isoamyl Nitrite · 1 trial · 1 indication
Incidence of related SAEs
To determine the dose that will result in a 6-10% MetHb level
| Arm | Type | Description |
|---|---|---|
| Cohort 1 SIAN | EXPERIMENTAL | SIAN dose of 0.28 mg/kg (20 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 2 SIAN | EXPERIMENTAL | SIAN dose of 0.73 mg/kg (50 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 3 SIAN | EXPERIMENTAL | SIAN dose of 1.45 mg/kg (100 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 4 SIAN | EXPERIMENTAL | SIAN dose of 2.18 mg/kg (150 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 5 SIAN | EXPERIMENTAL | SIAN dose of 2.90 mg/kg (200 μL) will be administered in two syringe-based spray devices, each containing 100 μL, with dose administered in left then right nostril, one device per nostril. For doses of 2.90 milligram/kilogram (200 microliter) and higher, the dose will be split equally between the two nostrils to avoid drug overflow from the nose (using two syringe-based spray devices one immediately followed by the other). Lower doses will be administered by a single device to one nostril. |
| Cohort 6 SIAN | EXPERIMENTAL | SIAN dose of 3.63 mg/kg (250 μL) will be administered in two syringe-based spray devices, each containing 125 μL, with dose administered in left then right nostril, one device per nostril. |
| Cohort 7 SIAN | EXPERIMENTAL | SIAN dose of 4.35 mg/kg (300 μL) will be administered in two syringe-based spray devices, each containing 150 μL, with dose administered in left then right nostril, one device per nostril. |
| Name | Type | Description |
|---|---|---|
| Stabilized Isoamyl Nitrite (SIAN) | DRUG | SIAN is comprised of isoamyl nitrite (IAN) stabilized with 4% by weight epoxidized linseed oil (ELSO) and administered by intranasal (IN) delivery as a nasal spray. A syringe-based spray device will be used to administer the SIAN product. This syringe-based spray device, consists of a Hamilton type syringe connected to a tip that functions as an atomizer, to provide an optimal spray plume for nasal absorption while minimizing exposure to lungs. |
Inclusion Criteria: 1. Able and willing to provide informed consent (and assent as applicable) voluntarily signed by subject/guardian/legally acceptable representative. 2. Generally healthy, in the opinion of the PI, medical history, physical examination, vital signs, ECG and laboratory assessments...
Stabilized Isoamyl Nitrite is being developed for cyanide poisoning. It is an investigational small molecule intended as a medical countermeasure for cyanide exposure. Emergent BioSolutions Inc. is developing the asset, which has completed a Phase 1 study in healthy adult volunteers.
Stabilized Isoamyl Nitrite is developed by Emergent BioSolutions Inc., which trades on the New York Stock Exchange under the ticker EBS. The company is advancing the candidate as a small molecule countermeasure for cyanide poisoning.
Stabilized Isoamyl Nitrite is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The candidate remains investigational and has not been approved by the FDA for cyanide poisoning.
Stabilized Isoamyl Nitrite has been studied in one completed Phase 1 trial, NCT05194358, titled Study of SIAN Nasal Spray in Healthy Adults. The trial enrolled 47 healthy adult volunteers in the United States and included a controlled design. No trials are currently active.
Yes. Stabilized Isoamyl Nitrite is also known as Stabilized Isoamyl Nitrite (SIAN), and the abbreviation SIAN is used in its clinical trial listing. The Phase 1 study NCT05194358 was conducted under the SIAN name for a nasal spray formulation.