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Theophylline alone
Theophylline alone is a Small molecule drug developed by Zhujiang Hospital. It is currently in Phase 1 development.
Theophylline is a phosphodiesterase 4 inhibitor, classified as an INHIBITOR drug modality. It has been studied in various clinical trials for conditions such as physiological function in low oxygen environments, mountain sickness, breast cancer, depression, and gout.
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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 | Theophylline alone |
|---|---|
| Sponsor | Zhujiang Hospital |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD
- Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage (PHASE1, PHASE2)
- Theophylline Nasal Spray for PD-Related Hyposmia and Anosmia (PHASE1)
- Effect of Tiotropium on Eye Findings in the Treatment of Chronic Obstructive Pulmonary Disease
- Effect of Tigulixostat on the Pharmacokinetics of Theophylline (PHASE1)
- Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults (PHASE2, PHASE3)
- Effect of Theophylline in Pseudohypoparathyroidism (PHASE4)
- Study of MK-0476 in Adult Patients With Acute Asthma (0476-334) (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:
- Theophylline alone CI brief — competitive landscape report
- Theophylline alone updates RSS · CI watch RSS
- Zhujiang Hospital portfolio CI
Frequently asked questions about Theophylline alone
What is Theophylline alone?
Who makes Theophylline alone?
What development phase is Theophylline alone in?
Related
- Manufacturer: Zhujiang Hospital — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing