Last reviewed · How we verify
Qualification
Qualification is a Small molecule drug developed by Tris Pharma, Inc.. It is currently in Phase 1 development.
Qualification is a treatment that has been studied for various conditions, including bradycardia, syncope, renal insufficiency, myelofibrosis, and safety issues. It involves interventions such as invasive electrophysiological study, extracardiac vagal stimulation, and cardioneuroablation, and has been compared to permanent pacing in a clinical trial.
-
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 | Qualification |
|---|---|
| Sponsor | Tris Pharma, Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Study: Tea(m)Time - Strengthening the Team Resilience of Hospital Staff Through the Tea(m)Time Intervention (NA)
- Standardization of Spatial Neglect Assessment Tests (NA)
- Nordic Walking Training Program for Sustaining Independent Walking in Older Adult Evacuees (NA)
- Hyaluronic Acid in the Treatment of Hyposalivation (PHASE1, PHASE2)
- A Study to Assess the Abuse Potential of Intranasal Cebranopadol (PHASE1)
- Evaluation of Haemodynamic in Neonates Treated With Hypothermia"
- AI Assisted Detection of Chest X-Rays
- Effect of Lean Leadership Training Program on Head Nurses' Lean Performance and Staff Nurses' Workplace Safety at Mansoura Children Hospital (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:
- Qualification CI brief — competitive landscape report
- Qualification updates RSS · CI watch RSS
- Tris Pharma, Inc. portfolio CI
Frequently asked questions about Qualification
What is Qualification?
Who makes Qualification?
What development phase is Qualification in?
Related
- Manufacturer: Tris Pharma, Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing