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SHP615
SHP615 is a monoclonal antibody targeting the PCSK9 protein.
SHP615 is a monoclonal antibody targeting the PCSK9 protein. Used for Hypercholesterolemia.
At a glance
| Generic name | SHP615 |
|---|---|
| Also known as | MHOS, Midazolam hydrochloride oromucosal solution |
| Sponsor | Shire |
| Drug class | PCSK9 inhibitor |
| Target | PCSK9 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
By binding to PCSK9, SHP615 reduces the amount of PCSK9 in the bloodstream, leading to increased levels of low-density lipoprotein (LDL) receptors on the liver surface, which in turn increases the clearance of LDL cholesterol from the blood.
Approved indications
- Hypercholesterolemia
Common side effects
- Injection site reactions
- Musculoskeletal pain
- Headache
Key clinical trials
- Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting (PHASE3)
- Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SHP615 CI brief — competitive landscape report
- SHP615 updates RSS · CI watch RSS
- Shire portfolio CI