This section highlights FDA-related milestones and regulatory updates for drugs developed by Medicus Pharma (MDCX).
Over the past two years, Medicus Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SKNJCT-003 and SKNJCT-004. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SKNJCT-003 - FDA Regulatory Timeline and Events
SKNJCT-003 is a drug developed by Medicus Pharma for the following indication: For the Treatment of Nodular Basal Cell Carcinoma.
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:
- SKNJCT-003
- Announced Date:
- March 6, 2025
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma Ltd. announce a positively trending interim analysis for SKNJCT-003 Phase 2 clinical study to non-invasively treat basal cell carcinoma of the skin (BCC).
AI Summary
Medicus Pharma Ltd. announced a positively trending interim analysis from its SKNJCT-003 Phase 2 study, which tests a non-invasive treatment for basal cell carcinoma (BCC) of the skin. The study, conducted across nine U.S. sites and involving more than 50% of the 60 planned patients, showed that over 60% of subjects achieved complete clinical clearance of BCC. Researchers found that the investigational product, D-MNA, was well tolerated at both 100μg and 200μg dose levels. No dose-limiting toxicities, serious adverse events, or abnormal laboratory, vital sign, ECG, or physical exam findings were observed.
Medicus Pharma plans to submit these interim results to the FDA as part of its package to request a Type C meeting in Q2 2025. This meeting aims to discuss further product development and secure alignment on fast-tracking the clinical pathway for this novel treatment approach to BCC.
Read Announcement- Drug:
- SKNJCT-003
- Announced Date:
- February 14, 2025
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma Ltd. announce that its phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States, has now randomized more than 50% of the 60 patients expected to be enrolled in the study.
AI Summary
Medicus Pharma Ltd. announced progress on its phase 2 clinical study (SKNJCT-003) running at nine clinical sites across the United States. The study, which is testing a dissolvable microneedle patch treatment for basal cell carcinoma, has now randomized over 50% of its planned 60 patients. This milestone shows the study is advancing well toward its target enrollment. The trial is comparing two dose levels of the drug D-MNA against a placebo in participants with nodular basal cell carcinoma. In addition, the company is on track to complete an interim data analysis before the end of the first quarter of 2025. Later, in the second quarter, Medicus Pharma plans to submit its findings to the FDA and discuss the clinical pathway for the product’s development.
Read Announcement
SKNJCT-004 - FDA Regulatory Timeline and Events
SKNJCT-004 is a drug developed by Medicus Pharma for the following indication: To Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC).
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:
- SKNJCT-004
- Announced Date:
- February 27, 2025
- Indication:
- To Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)
Announcement
Medicus Pharma Ltd. announce that it has submitted a clinical design (SKNJCT-004) to UAE DOH to non-invasively treat BCC of the skin.
AI Summary
Medicus Pharma Ltd. recently submitted a clinical study design, SKNJCT-004, to the UAE Department of Health for a new non-invasive treatment approach against basal cell carcinoma (BCC) of the skin. This study aims to evaluate the safety and effectiveness of a dissolvable microneedle patch, D-MNA, administered at two different dose levels, compared to a placebo. The trial is planned to include 36 participants and will be held at four medical sites across the UAE, including Cleveland Clinic Abu Dhabi, Sheikh Shakbout Medical City, Burjeel Medical City, and the American Hospital of Dubai.
The trial is set up as a randomized, double-blind, placebo-controlled, multi-center study, ensuring reliable and unbiased results. By pursuing this study, Medicus Pharma aims to further demonstrate the potential of its novel, non-invasive treatment, which could offer a promising new option for patients suffering from BCC of the skin.
Read Announcement
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