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Seprafilm
Seprafilm is a Biologic drug developed by Stan Stawicki. It is currently in Phase 1 development.
Seprafilm is a medical product used to prevent adhesions in patients undergoing surgery, specifically in conditions such as colorectal and stomach cancer surgery, intrauterine adhesions, and tissue adhesions. It has been studied in clinical trials as a treatment option for preventing adhesions, including a randomized control trial comparing it to Guardix and a sterile saline solution.
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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 | Seprafilm |
|---|---|
| Sponsor | Stan Stawicki |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Seprafilm® Adhesion Barrier and Cesarean Delivery (PHASE4)
- The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions (NA)
- A Trial to Reduce Adhesions Following a Primary Cesarean Section (NA)
- The Efficacy of a Topical Anti-adhesive Film for Decreasing Perihepatic Adhesions in Repeat Hepatic Surgery (NA)
- Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy (PHASE4)
- An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen (NA)
- Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients (NA)
- A Study Into the Effect of Seprafilm in Open Total Thyroidectomy (NA)
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:
- Seprafilm CI brief — competitive landscape report
- Seprafilm updates RSS · CI watch RSS
- Stan Stawicki portfolio CI
Frequently asked questions about Seprafilm
What is Seprafilm?
Who makes Seprafilm?
What development phase is Seprafilm in?
Related
- Manufacturer: Stan Stawicki — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing