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MK-4305 40 mg
MK-4305 40 mg is a Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 1 development.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | MK-4305 40 mg |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Somnolence
- Headache
- Nasopharyngitis
- headache
- Fatigue
- somnolence
- Upper respiratory tract infection
- Dizziness
- nasopharnygitis
- Urinary tract infection
- Nausea
- Atrioventricular block second degree
Key clinical trials
- A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users (PHASE1)
- Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029) (PHASE3)
- Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006) (PHASE2)
- A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3) (PHASE3)
- Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028) (PHASE3)
- Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032) (PHASE1)
- Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036) (PHASE1)
- A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1) (PHASE1)
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:
- MK-4305 40 mg CI brief — competitive landscape report
- MK-4305 40 mg updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about MK-4305 40 mg
What is MK-4305 40 mg?
Who makes MK-4305 40 mg?
What development phase is MK-4305 40 mg in?
What are the side effects of MK-4305 40 mg?
Related
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing