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Cyclokapron
Cyclokapron is a Small molecule drug developed by Mary M. Gooley Hemophilia Center. It is currently in Phase 1 development. Also known as: tranexamic Acid.
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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 | Cyclokapron |
|---|---|
| Also known as | tranexamic Acid |
| Sponsor | Mary M. Gooley Hemophilia Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Nausea
- Vomiting
- Dizziness
- Urticaria or dermatitis
Key clinical trials
- Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma (NA)
- Tranexamic Acid for The Treatment of Gastrointestinal Bleeding (NA)
- Hemoglobin Drop and Need for Blood Transfusion in Primary Knee Arthroplasty With or Without Drain Insertion (NA)
- Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty (NA)
- Prevention of Postpartum Hemorrhage With Tranexamic Acid (PHASE2)
- Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre (NA)
- Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial (PHASE3)
- The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies (PHASE3)
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:
- Cyclokapron CI brief — competitive landscape report
- Cyclokapron updates RSS · CI watch RSS
- Mary M. Gooley Hemophilia Center portfolio CI
Frequently asked questions about Cyclokapron
What is Cyclokapron?
Who makes Cyclokapron?
Is Cyclokapron also known as anything else?
What development phase is Cyclokapron in?
What are the side effects of Cyclokapron?
Related
- Manufacturer: Mary M. Gooley Hemophilia Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: tranexamic Acid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing