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Sildenafil ODT
Sildenafil ODT is a Small molecule drug developed by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. It is currently in Phase 1 development.
Sildenafil ODT is a formulation of the medication sildenafil, which is used to treat erectile dysfunction. It is an orally disintegrating tablet that can be taken without food, as demonstrated in a clinical study (NCT01254396) evaluating its pharmacokinetics and safety in healthy older male subjects.
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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). -
Big-pharma sponsor
+3.0pp
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Sildenafil ODT |
|---|---|
| Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet. (PHASE1)
- Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet (PHASE1)
- Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food. (PHASE1)
- Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil (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:
- Sildenafil ODT CI brief — competitive landscape report
- Sildenafil ODT updates RSS · CI watch RSS
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. portfolio CI
Frequently asked questions about Sildenafil ODT
What is Sildenafil ODT?
Who makes Sildenafil ODT?
What development phase is Sildenafil ODT in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing