Last reviewed · How we verify
Cialis Tab. 5mg
Cialis Tab. 5mg is a Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 1 development. Also known as: Tadalafil 5mg.
-
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 | Cialis Tab. 5mg |
|---|---|
| Also known as | Tadalafil 5mg |
| Sponsor | Chong Kun Dang Pharmaceutical |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Headache (Female)
- Nausea (Male)
- Headache (Male)
- Abdominal distension (Male)
- Gamma-glutamyltransferase increased (Male)
- Pain in extremity (Male)
- Non-cardiac chest pain (Male)
- Back Pain (Male)
Key clinical trials
- Trial of Tadalafil, Tamsulosin and Combination for Access Sheath Deployment (PHASE4)
- Efficacy and Tolerability of Tadalafil Versus Darifenacin in Management of Ureteric Stent-Related LUTS (PHASE1, PHASE2)
- The Phosphodiesterase Inhibitor Tadalafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients (PHASE1, PHASE2)
- Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension (PHASE2)
- Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults
- Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia (PHASE3)
- Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction (PHASE3)
- The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy (PHASE4)
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:
- Cialis Tab. 5mg CI brief — competitive landscape report
- Cialis Tab. 5mg updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI
Frequently asked questions about Cialis Tab. 5mg
What is Cialis Tab. 5mg?
Who makes Cialis Tab. 5mg?
Is Cialis Tab. 5mg also known as anything else?
What development phase is Cialis Tab. 5mg in?
What are the side effects of Cialis Tab. 5mg?
Related
- Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
- Also known as: Tadalafil 5mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing