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NEOSTIGMINE BROMIDE
NEOSTIGMINE BROMIDE is a drug. It is currently in Phase 2 development.
Neostigmine bromide is an injectable product used to treat various conditions, including gallbladder diseases, postoperative cognitive dysfunction, cesarean section complications, postoperative delirium, and neuromuscular blockade. It is used as an intervention in clinical trials, often in comparison to sugammadex, a product used for similar purposes.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | NEOSTIGMINE BROMIDE |
|---|---|
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Procedural pain
- Nausea
- Constipation
- Pain
- Sleep disorder
- Anaemia
- Vomiting
- Anaemia postoperative
- Haematoma
- Oedema peripheral
- Arthralgia
- Insomnia
Key clinical trials
- Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function (NA)
- Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture (PHASE2)
- Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease (PHASE4)
- Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia (NA)
- A Comparative Study Between Combination of Propofol and Dexmedetomidine Versus Propofol Alone in Anesthesia for Rigid Bronchoscopy by Using the Patient State Index Monitor (PHASE4)
- NMBA Reversal and Postoperative Urinary Retention
- Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection (PHASE4)
- Sugammadex Vs Neostigmine in Reversing Neuromuscular Blocks in Outpatient ERCP. A Randomized, Double-Blinded Trial (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:
- NEOSTIGMINE BROMIDE CI brief — competitive landscape report
- NEOSTIGMINE BROMIDE updates RSS · CI watch RSS
Frequently asked questions about NEOSTIGMINE BROMIDE
What is NEOSTIGMINE BROMIDE?
What development phase is NEOSTIGMINE BROMIDE in?
What are the side effects of NEOSTIGMINE BROMIDE?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing