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IV Methylnaltrexone
IV Methylnaltrexone is a Small molecule drug developed by Bausch Health Americas, Inc.. It is currently in Phase 2 development.
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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 | IV Methylnaltrexone |
|---|---|
| Sponsor | Bausch Health Americas, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function (PHASE1)
- Dasatinib, Bevacizumab, Paclitaxel in Patients With Advanced Malignancies (PHASE1)
- Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone (PHASE2)
- Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide (PHASE1)
- Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan (PHASE1)
- Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus (PHASE2)
- Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose (PHASE1)
- Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX (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:
- IV Methylnaltrexone CI brief — competitive landscape report
- IV Methylnaltrexone updates RSS · CI watch RSS
- Bausch Health Americas, Inc. portfolio CI
Frequently asked questions about IV Methylnaltrexone
What is IV Methylnaltrexone?
Who makes IV Methylnaltrexone?
What development phase is IV Methylnaltrexone in?
Related
- Manufacturer: Bausch Health Americas, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing