Relistor Injectable Product

Methodist Health System · Phase 2 active Small molecule

Relistor Injectable Product is a Small molecule drug developed by Methodist Health System. It is currently in Phase 2 development. Also known as: Methylnaltrexone Bromide.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• 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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Relistor Injectable Product
Also known as	Methylnaltrexone Bromide
Sponsor	Methodist Health System
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• RELISTOR's Effects on Opioid-Induced Constipation
• Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics (NA)
• Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study. (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:

• Relistor Injectable Product CI brief — competitive landscape report
• Relistor Injectable Product updates RSS · CI watch RSS
• Methodist Health System portfolio CI

Frequently asked questions about Relistor Injectable Product

What is Relistor Injectable Product?

Relistor Injectable Product is a Small molecule drug developed by Methodist Health System.

Who makes Relistor Injectable Product?

Relistor Injectable Product is developed by Methodist Health System (see full Methodist Health System pipeline at /company/methodist-health-system).

Is Relistor Injectable Product also known as anything else?

Relistor Injectable Product is also known as Methylnaltrexone Bromide.

What development phase is Relistor Injectable Product in?

Relistor Injectable Product is in Phase 2.

Related

• Manufacturer: Methodist Health System — full pipeline
• Also known as: Methylnaltrexone Bromide