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Pyrrolidine
Pyrrolidine is a Small molecule drug developed by Xijing Hospital. It is currently in Phase 2 development.
Pyrrolidine is an organic compound with the molecular formula (CH2)4NH, classified as a cyclic secondary amine and a saturated heterocycle. It is a colourless liquid that is miscible with water and most organic solvents, with a characteristic odor described as "ammoniacal, fishy, shellfish-like".
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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 | Pyrrolidine |
|---|---|
| Sponsor | Xijing Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- The Role of Eicosanoids in the Cardiovascular Actions of Inhaled Nanoparticles (NA)
- Preoperative Treatment of HR+/HER2+Breast Cancer With Pirotinib, Trastuzumab and AI Research (PHASE2)
- Mechanism Exploration of Anti-HER-2 Small-molecule Tyrosine Kinase Inhibitor-related Diarrhea and Establishment of Prevention and Treatment Model(Measure) (NA)
- A Single Arm Study of Brain Metastasis in Patients With HER2-positive Breast Cancer (PHASE4)
- Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer (PHASE2)
- Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698 (PHASE2)
- Breast Cancer Treatment Based on Organ-like Culture
- Trial to Incentivise Adherence for Diabetes (NA)
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:
- Pyrrolidine CI brief — competitive landscape report
- Pyrrolidine updates RSS · CI watch RSS
- Xijing Hospital portfolio CI
Frequently asked questions about Pyrrolidine
What is Pyrrolidine?
Who makes Pyrrolidine?
What development phase is Pyrrolidine in?
Related
- Manufacturer: Xijing Hospital — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing