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Rocuronium bromide (Org 9426)
Rocuronium bromide (Org 9426) is a Non-depolarizing neuromuscular blocking agent Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Endotracheal intubation, Surgical procedures requiring muscle relaxation. Also known as: SCH 900085.
Rocuronium bromide is a non-depolarizing neuromuscular blocking agent that competitively inhibits the nicotinic acetylcholine receptor at the neuromuscular junction.
Rocuronium bromide (Org 9426) is a small molecule antagonist that targets the muscle-type nicotinic acetylcholine receptor. It is used in clinical settings for procedures such as general anesthesia, tracheal intubation, and pain management, including postoperative pain and intravenous anesthesia.
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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 bromide (Org 9426) |
|---|---|
| Also known as | SCH 900085 |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Non-depolarizing neuromuscular blocking agent |
| Target | Nicotinic acetylcholine receptor |
| Modality | Small molecule |
| Therapeutic area | Anesthesiology |
| Phase | Phase 3 |
Mechanism of action
By binding to the nicotinic acetylcholine receptor, rocuronium bromide prevents acetylcholine from binding and initiating muscle contraction, resulting in muscle paralysis. This effect is reversible with anticholinesterases or by allowing time for spontaneous recovery. The precise mechanism of action is not fully understood, but it is thought to involve a combination of competitive inhibition and allosteric modulation of the nicotinic acetylcholine receptor.
Approved indications
- Endotracheal intubation
- Surgical procedures requiring muscle relaxation
Common side effects
- Hypotension
- Bradycardia
- Respiratory depression
- Muscle weakness
- Anaphylaxis
Key clinical trials
- The Relationship Between Opioid-Free Anesthesia and Postoperative Agitation-Delirium and Quality of Recovery in Pediatric Ear, Nose, and Throat Cases Monitored With Perioperative Bispectral Index
- Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function (NA)
- Association of Sarcopenia With Rocuronium Use in Liver Transplant Recipients (NA)
- Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery. (NA)
- Deep Versus Moderate Neuromuscular Blocking (NA)
- Effect of Neuromuscular Block Depth on Driving Pressure and Postoperative Respiratory Events in Abdominal Surgeries (NA)
- Safety and Efficacy of HRS-9190 Compared to Rocuronium for Bolus Maintenance in Adults (PHASE2)
- A Dose-response Study to Determine the Right Dosage of Sugammadex as a Reversal Agent of Rocuronium in Infants Between 1 and 24 Months Old (PHASE4)
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 bromide (Org 9426) CI brief — competitive landscape report
- Rocuronium bromide (Org 9426) updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Rocuronium bromide (Org 9426)
What is Rocuronium bromide (Org 9426)?
How does Rocuronium bromide (Org 9426) work?
What is Rocuronium bromide (Org 9426) used for?
Who makes Rocuronium bromide (Org 9426)?
Is Rocuronium bromide (Org 9426) also known as anything else?
What drug class is Rocuronium bromide (Org 9426) in?
What development phase is Rocuronium bromide (Org 9426) in?
What are the side effects of Rocuronium bromide (Org 9426)?
What does Rocuronium bromide (Org 9426) target?
Related
- Drug class: All Non-depolarizing neuromuscular blocking agent 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 Surgical procedures requiring muscle relaxation
- Also known as: SCH 900085
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing