Last reviewed · How we verify
picibanil
picibanil is a Small molecule drug developed by University of Iowa. It is currently in Phase 2 development. Also known as: OK432.
Picibanil, also known as OK-432, is a mixture of group A streptococcus used in the treatment of various conditions, including pancreatic cancer, head and neck cancer, and cystic hygroma (lymphangiomas). Its mechanism of action is not specified in the provided information, but it is used in immunotherapy treatments involving dendritic cells.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | picibanil |
|---|---|
| Also known as | OK432 |
| Sponsor | University of Iowa |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- OK432 (Picibanil) in the Treatment of Lymphatic Malformations (PHASE2)
- The Efficacy of OK-432 Pleurodesis on Postoperative Air Leak (NA)
- Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations (PHASE2, PHASE3)
- Contrast The Role of Avitene And OK-432 in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer (PHASE4)
- Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432 (PHASE4)
- Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer (PHASE1, PHASE2)
- Study of Chemo-Immunotherapy in Head and Neck Cancer Patients (PHASE1)
- Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers (PHASE1)
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:
- picibanil CI brief — competitive landscape report
- picibanil updates RSS · CI watch RSS
- University of Iowa portfolio CI
Frequently asked questions about picibanil
What is picibanil?
Who makes picibanil?
Is picibanil also known as anything else?
What development phase is picibanil in?
Related
- Manufacturer: University of Iowa — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: OK432
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing