Last reviewed · How we verify
TPN171H single dose
TPN171H single dose is a Small molecule drug developed by Vigonvita Life Sciences. It is currently in Phase 1 development.
TPN171H is a single dose intervention being studied for its effects on Erectile Dysfunction and Pulmonary Arterial Hypertension, as well as its impact on semen function in healthy male subjects. The mechanism of action of TPN171H is currently unknown.
-
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 | TPN171H single dose |
|---|---|
| Sponsor | Vigonvita Life Sciences |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension (PHASE2)
- A Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Insufficiency and Healthy Subjects (PHASE1)
- Safety and Pharmacokinetics of a Single Oral TPN171H in Healthy Elderly Subjects (PHASE1)
- Drug-Drug Interaction (DDI) Study for TPN171H (PHASE1)
- Evaluate the Effect of TPN171H on the QT/QTc Interval in Healthy Volunteers (PHASE1)
- Effect of TPN171H on Spermatogenesis (PHASE1)
- Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild ,Moderate Hepatic Insufficiency and Normal Liver Function (PHASE1)
- Mass Balance of Oral [14C]TPN171H in Healthy Male Subjects (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:
- TPN171H single dose CI brief — competitive landscape report
- TPN171H single dose updates RSS · CI watch RSS
- Vigonvita Life Sciences portfolio CI
Frequently asked questions about TPN171H single dose
What is TPN171H single dose?
Who makes TPN171H single dose?
What development phase is TPN171H single dose in?
Related
- Manufacturer: Vigonvita Life Sciences — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing