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Rocuronium bolus maintenance
Rocuronium bolus maintenance is a Non-depolarizing neuromuscular blocker Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Endotracheal intubation, Skeletal muscle relaxation during surgery. Also known as: Zemuron, ORG 9426.
Rocuronium acts as a competitive antagonist at the nicotinic acetylcholine receptor, preventing acetylcholine from binding and thereby inhibiting muscle contraction.
Rocuronium is a small molecule antagonist that targets the muscle-type nicotinic acetylcholine receptor, used for muscle relaxation and neuromuscular blockade. It is indicated for conditions such as muscle relaxation, neuromuscular blockade, postoperative delirium, chronic kidney diseases, and renal transplantation.
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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). -
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 | 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 | Rocuronium bolus maintenance |
|---|---|
| Also known as | Zemuron, ORG 9426 |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Non-depolarizing neuromuscular blocker |
| Target | Nicotinic acetylcholine receptor |
| Modality | Small molecule |
| Therapeutic area | Anesthesiology |
| Phase | Phase 3 |
Mechanism of action
This action results in muscle relaxation, which is useful for facilitating endotracheal intubation and providing skeletal muscle relaxation during surgery. Rocuronium's mechanism of action is similar to other non-depolarizing neuromuscular blockers.
Approved indications
- Endotracheal intubation
- Skeletal muscle relaxation during surgery
Common side effects
- Hypotension
- Bradycardia
- Respiratory depression
Key clinical trials
- Safety and Efficacy of HRS-9190 Compared to Rocuronium for Bolus Maintenance in Adults (PHASE2)
- Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy (NA)
- Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery (NA)
- The Effects of Three Different Anesthetic Methods on Postoperative Agitation (NA)
- Intraoperative Multimodal Monitoring as a Means in Reducing the Duration of Mechanical Ventilation in High-Risk Patients Undergoing Major Abdominal Procedures - A Pilot Study (NA)
- LAPOFAR Trial: Opioid-Free vs. Remifentanil Anesthesia in Laparoscopic Cholecystectomy (NA)
- Effect of OFA, OSA Versus Opioid-based Anesthesia on NETs and Cancer Cell Malignancy After Colorectal Cancer Surgery (NA)
- Effectiveness of Dexmedetomidine Versus Sufentanil on Cerebral Oxygen Saturation in Patients With Traumatic Brain Injury (NA)
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:
- Rocuronium bolus maintenance CI brief — competitive landscape report
- Rocuronium bolus maintenance updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Rocuronium bolus maintenance
What is Rocuronium bolus maintenance?
How does Rocuronium bolus maintenance work?
What is Rocuronium bolus maintenance used for?
Who makes Rocuronium bolus maintenance?
Is Rocuronium bolus maintenance also known as anything else?
What drug class is Rocuronium bolus maintenance in?
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What does Rocuronium bolus maintenance target?
Related
- Drug class: All Non-depolarizing neuromuscular blocker drugs
- Target: All drugs targeting Nicotinic acetylcholine receptor
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Anesthesiology
- Indication: Drugs for Endotracheal intubation
- Indication: Drugs for Skeletal muscle relaxation during surgery
- Also known as: Zemuron, ORG 9426
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing