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Intact
Intact is a Small molecule drug developed by Vanderbilt University. It is currently in Phase 1 development. Also known as: Saline.
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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 | Intact |
|---|---|
| Also known as | Saline |
| Sponsor | Vanderbilt University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial (PHASE2)
- Removal of the Ovaries/Fallopian Tubes and CA-125 Screening to Reduce the Risk of Ovarian Cancer in Women at Increased Genetic Risk
- Manual Therapy in Improving Quality of Life in Women With Dyspareunia (NA)
- Brief Intervention at Adult Education (NA)
- Exercise, Irritable Bowel Syndrome and Fibromyalgia (NA)
- A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01 (PHASE1)
- Pilot Trial of Spiritual Care Interventions for Patients With Cancer (NA)
- Elamrousy Modified Approach for Socket Shield Technique (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:
- Intact CI brief — competitive landscape report
- Intact updates RSS · CI watch RSS
- Vanderbilt University portfolio CI
Frequently asked questions about Intact
What is Intact?
Who makes Intact?
Is Intact also known as anything else?
What development phase is Intact in?
Related
- Manufacturer: Vanderbilt University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Saline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing