Last reviewed · How we verify
Methylxanthine
Methylxanthine is a Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Methylxanthine |
|---|---|
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pentoxifylline in Patients With Ulcerative Colitis (PHASE2)
- Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis (PHASE2)
- Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis (PHASE2)
- Impact of Methylxanthine Intake and Blue Light Exposure on Adhesive Shoulder Capsulitis. (NA)
- Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis. (PHASE2)
- Pentoxifylline Dose Optimization in Neonatal Sepsis (PHASE3)
- Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ) (PHASE3)
- Investigational and Comparative Study in the Management of Diabetic Nephropathy (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:
- Methylxanthine CI brief — competitive landscape report
- Methylxanthine updates RSS · CI watch RSS
- National Heart, Lung, and Blood Institute (NHLBI) portfolio CI
Frequently asked questions about Methylxanthine
What is Methylxanthine?
Who makes Methylxanthine?
What development phase is Methylxanthine in?
Related
- Manufacturer: National Heart, Lung, and Blood Institute (NHLBI) — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing