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MHOS/SHP615
MHOS/SHP615 is a Growth hormone secretagogue Small molecule drug developed by Shire. It is currently in Phase 3 development for Growth hormone deficiency in adults.
MHOS/SHP615 is a long-acting growth hormone secretagogue (ghrelin receptor agonist) that stimulates growth hormone release.
MHOS/SHP615 is a midazolam hydrochloride oromucosal solution used to treat status epilepticus in children. It is being studied in a Phase 3 clinical trial (NCT03336645) sponsored by Takeda.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | MHOS/SHP615 |
|---|---|
| Sponsor | Shire |
| Drug class | Growth hormone secretagogue |
| Target | Ghrelin receptor (GHSR-1a) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
SHP615 activates the ghrelin receptor (growth hormone secretagogue receptor 1a) to promote endogenous growth hormone secretion. This mechanism aims to restore physiological growth hormone levels in patients with growth hormone deficiency, potentially offering advantages over recombinant human growth hormone therapy through stimulation of the body's own GH production.
Approved indications
- Growth hormone deficiency in adults
Common side effects
- Increased appetite
- Weight gain
- Injection site reactions
- 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:
- MHOS/SHP615 CI brief — competitive landscape report
- MHOS/SHP615 updates RSS · CI watch RSS
- Shire portfolio CI
Frequently asked questions about MHOS/SHP615
What is MHOS/SHP615?
How does MHOS/SHP615 work?
What is MHOS/SHP615 used for?
Who makes MHOS/SHP615?
What drug class is MHOS/SHP615 in?
What development phase is MHOS/SHP615 in?
What are the side effects of MHOS/SHP615?
What does MHOS/SHP615 target?
Related
- Drug class: All Growth hormone secretagogue drugs
- Target: All drugs targeting Ghrelin receptor (GHSR-1a)
- Manufacturer: Shire — full pipeline
- Therapeutic area: All drugs in Endocrinology
- Indication: Drugs for Growth hormone deficiency in adults
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing