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Tranilast, and Tissucol
Tranilast, and Tissucol is a Anti-fibrotic agent (Tranilast); Fibrin sealant (Tissucol) Small molecule drug developed by Gildasio Castello de Almeida Junior. It is currently in Phase 3 development for Hypertrophic scars and keloid prevention/treatment, Post-surgical wound healing and hemostasis. Also known as: Rizaben, Tissucol.
Tranilast inhibits fibroblast proliferation and collagen synthesis, while Tissucol is a fibrin sealant that promotes tissue adhesion and hemostasis.
Tranilast is a small molecule used as an adjunctive therapy before primary pterygium excision, as studied in the clinical trial "Evaluation of Tranilast to Treat Pterygium Before Excision" (NCT01003613). Tissucol, also known as Beriplast P, is a different intervention used in the same clinical trial, with no information available on its mechanism or use in treating pterygium.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Tranilast, and Tissucol |
|---|---|
| Also known as | Rizaben, Tissucol |
| Sponsor | Gildasio Castello de Almeida Junior |
| Drug class | Anti-fibrotic agent (Tranilast); Fibrin sealant (Tissucol) |
| Target | TGF-β pathway (Tranilast); Fibrin polymerization (Tissucol) |
| Modality | Small molecule |
| Therapeutic area | Dermatology, Wound Healing, Surgery |
| Phase | Phase 3 |
Mechanism of action
Tranilast is an anti-allergic and anti-fibrotic agent that suppresses transforming growth factor-beta (TGF-β) signaling and reduces fibroblast activity, thereby limiting excessive collagen deposition and scar formation. Tissucol is a two-component fibrin glue composed of fibrinogen and thrombin that creates a physiologic clot to seal tissues and promote wound healing. The combination may leverage Tranilast's anti-fibrotic properties alongside Tissucol's hemostatic and adhesive functions.
Approved indications
- Hypertrophic scars and keloid prevention/treatment
- Post-surgical wound healing and hemostasis
Common side effects
- Local irritation or inflammation at application site
- Allergic reaction to fibrin components
- Infection at wound site
Key clinical trials
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:
- Tranilast, and Tissucol CI brief — competitive landscape report
- Tranilast, and Tissucol updates RSS · CI watch RSS
- Gildasio Castello de Almeida Junior portfolio CI
Frequently asked questions about Tranilast, and Tissucol
What is Tranilast, and Tissucol?
How does Tranilast, and Tissucol work?
What is Tranilast, and Tissucol used for?
Who makes Tranilast, and Tissucol?
Is Tranilast, and Tissucol also known as anything else?
What drug class is Tranilast, and Tissucol in?
What development phase is Tranilast, and Tissucol in?
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What does Tranilast, and Tissucol target?
Related
- Drug class: All Anti-fibrotic agent (Tranilast); Fibrin sealant (Tissucol) drugs
- Target: All drugs targeting TGF-β pathway (Tranilast); Fibrin polymerization (Tissucol)
- Manufacturer: Gildasio Castello de Almeida Junior — full pipeline
- Therapeutic area: All drugs in Dermatology, Wound Healing, Surgery
- Indication: Drugs for Hypertrophic scars and keloid prevention/treatment
- Indication: Drugs for Post-surgical wound healing and hemostasis
- Also known as: Rizaben, Tissucol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing