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Prograf capsule 1mg
Prograf capsule 1mg is a Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 1 development.
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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 | Prograf capsule 1mg |
|---|---|
| Sponsor | Chong Kun Dang Pharmaceutical |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- WOUND COMPLICATION
- HYPERTENSION
- HYPERKALAEMIA
- Headache
- URINARY TRACT INFECTION
- NEPHROGENIC ANAEMIA
- DIARRHOEA
- COMPLICATIONS OF TRANSPLANTED KIDNEY
- HYPOCALCAEMIA
- HYPOKALAEMIA
- HYPOMAGNESAEMIA
- BLADDER PAIN
Key clinical trials
- Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial (PHASE2, PHASE3)
- PLATO - Medication Adherence in Transplant Recipients (NA)
- The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment (PHASE4)
- Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome (PHASE4)
- Bioequivalence Study of Tacrolimus in Healthy Volunteers (PHASE1)
- A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers (PHASE1)
- Tacrolimus Treatment for Refractory Autoimmune Cytopenia (PHASE4)
- Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients (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:
- Prograf capsule 1mg CI brief — competitive landscape report
- Prograf capsule 1mg updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI
Frequently asked questions about Prograf capsule 1mg
What is Prograf capsule 1mg?
Who makes Prograf capsule 1mg?
What development phase is Prograf capsule 1mg in?
What are the side effects of Prograf capsule 1mg?
Related
- Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing