This section highlights FDA-related milestones and regulatory updates for drugs developed by Scinai Immunotherapeutics (SCNI).
Over the past two years, Scinai Immunotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IL-17 and PC111. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
IL-17 FDA Regulatory Events
IL-17 is a drug developed by Scinai Immunotherapeutics for the following indication: For the treatment of mild to moderate plaque psoriasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IL-17
- Announced Date:
- July 23, 2024
- Indication:
- For the treatment of mild to moderate plaque psoriasis
Announcement
Scinai Immunotherapeutics Ltd. announced the receipt of minutes of meeting from a recent Scientific Advice ("SA") with the Paul Erlich Institute, Federal Institute for Vaccines and Biomedicines (the "PEI"), which is considered acceptable guidance for IMPD filing with the European Medicines Agency (EMA) and is also considered the European comparable to a pre-IND meeting with the FDA in the U.S.
AI Summary
Scinai Immunotherapeutics Ltd. announced that it has received the minutes from a recent Scientific Advice meeting with the Paul Erlich Institute (PEI). This meeting provided important regulatory guidance that the company can use for its Investigational Medicinal Product Dossier (IMPD) filing with the European Medicines Agency (EMA). In Europe, this advice is seen as equivalent to a pre-Investigational New Drug (IND) meeting with the FDA in the United States. The positive feedback from the PEI supports Scinai’s plans to advance its anti-IL-17A/F nanoAb drug for the treatment of mild to moderate plaque psoriasis. According to the guidance, the company can proceed with its strategy of streamlining clinical evaluations, which could result in significant time and cost savings. This clear regulatory pathway provides a strong foundation as Scinai moves forward with its Phase 1/2a clinical trial preparations.
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PC111 FDA Regulatory Events
PC111 is a drug developed by Scinai Immunotherapeutics for the following indication: For Pemphigus and SJS/TEN.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PC111
- Announced Date:
- July 29, 2025
- Indication:
- For Pemphigus and SJS/TEN
Announcement
Scinai Immunotherapeutics Ltd. announced the publication of a new peer-reviewed article in the Journal of Dermatological Treatment validating the disease-modifying potential of PC111, a first-in-class human anti-Fas Ligand monoclonal antibody.
AI Summary
Scinai Immunotherapeutics announced that a new peer-reviewed article in the Journal of Dermatological Treatment validates the disease-modifying potential of PC111, a first-in-class human anti-Fas Ligand monoclonal antibody. Authored by Dr. Roberta Lotti and colleagues, the study confirms that PC111 prevents blister formation in in vitro, ex vivo, and in vivo humanized models of pemphigus by targeting soluble Fas Ligand, a key factor in keratinocyte apoptosis and acantholysis.
Building on award-winning research, the paper shows PC111’s non-immunosuppressive action at the skin cell level. Data from a proprietary humanized FasL mouse model demonstrated a significant reduction in disease activity. The authors also highlight PC111’s promise in treating Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis by preventing FasL-mediated keratinocyte apoptosis and ocular damage. With orphan drug designation in the EU and planned studies in the U.S., PC111 offers a safer, fast-acting alternative to chronic immunosuppression.
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