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, Teverelix, and SKNJCT-004. 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.
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:
- May 6, 2026
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma Ltd announced results from a pre-specified expanded dataset analysis demonstrating positive dose response from its Phase 2 SKNJCT-003 study evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to treat nodular basal cell carcinoma (BCC) of the skin, the most common type of skin cancer..
AI Summary
Medicus Pharma reported results from a pre-specified expanded analysis of 69 patients in its randomized, double-blind Phase 2 SKNJCT-003 study of Doxorubicin Microneedle Array (D-MNA) for nodular basal cell carcinoma. The trial randomized participants to device control, 100 µg D-MNA, or 200 µg D-MNA. The refined dataset showed a clear, dose-dependent benefit, with the 200 µg cohort showing the strongest and most consistent activity by Day 57; clearance rates improved between Day 29 and Day 57, indicating ongoing biological effect.
D-MNA was generally well tolerated, with no drug-related serious adverse events, no evidence of systemic doxorubicin toxicity, and mostly mild local reactions. Independent investigator review supported the findings. Medicus said these results suggest many treated lesions may be able to avoid immediate surgical excision and could inform dose, timing, and lesion selection in future development.
Read Announcement- Drug:
- SKNJCT-003
- Announced Date:
- April 1, 2026
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma Ltd. issued a clarification regarding previously reported topline results from its Phase 2 clinical study of SKNJCT-003 in nodular basal cell carcinoma (BCC).
AI Summary
Medicus Pharma clarified topline results from its Phase 2 study of SKNJCT-003 (SkinJect), an investigational doxorubicin-containing microneedle array being developed as a non-surgical option for nodular basal cell carcinoma. The company said earlier data presentation—especially about a device-only arm—may have caused confusion and wanted to explain how the results should be interpreted for development.
Medicus emphasized the device-only arm (P-MNA/C-MNA) was included only for scientific and mechanistic context and did not contain drug. The company’s regulatory and clinical focus is on the active drug-device combination arms that deliver intratumoral doxorubicin, specifically the 100 µg and 200 µg cohorts.
Topline findings showed clinically meaningful activity in the active cohorts, with the 200 µg dose showing the strongest and continuing improvement through Day 57. The forthcoming Clinical Study Report will center on active-arm clinical and histological outcomes and dose response, while treating the device-only arm as supportive, non-pivotal data. Medicus said the dataset supports moving toward registrational planning focused on the 200 µg regimen.
Read Announcement- Drug:
- SKNJCT-003
- Announced Date:
- March 18, 2026
- Target Action Date:
- March 19, 2026
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma Ltd announced today that members of its executive management team, led by Dr. Raza Bokhari, Executive Chairman & CEO, will participate in a live fireside chat on Thursday, March 19, 2026, hosted by Kumaraguru (Kumar) Raja, Ph.D., Senior Biotechnology Analyst at Brookline Capital Markets.
AI Summary
Medicus Pharma Ltd. said members of its executive team, led by Dr. Raza Bokhari, Executive Chairman & CEO, will take part in a live fireside chat on Thursday, March 19, 2026, hosted by Kumaraguru (Kumar) Raja, Ph.D., Senior Biotechnology Analyst at Brookline Capital Markets. Dr. Bokhari will give a company update and review the positive SkinJect® SKNJCT-003 Phase 2 topline results reported earlier this month.
The randomized, double-blind, three-arm Phase 2 study compared microneedle delivery of doxorubicin to a device-only control in nodular basal cell carcinoma. In the 200‑µg doxorubicin arm, clinical clearance was 73% at Day 57 versus 38% for the device-only control, suggesting roughly 3 out of 4 treated lesions may avoid immediate surgery. The company says this separation supports a drug-mediated effect on a biologically active microneedle platform and justifies continued development.
The fireside chat will include a live Q&A and will not be recorded. Medicus indicated the data support moving SkinJect toward regulatory discussions and potential partnerships.
Read Announcement- Drug:
- SKNJCT-003
- Announced Date:
- March 16, 2026
- Target Action Date:
- March 26, 2026
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma Ltd. announced that Babar K. Rao, MD, FAAD, an internationally recognized academic dermatologist and Principal Investigator of the SKNJCT-003 Phase 2 clinical study, will join the Company's leadership team during a business update webcast on March 26, 2026 at 11:30 a.m. Eastern time.
AI Summary
Medicus Pharma announced that Babar K. Rao, MD, FAAD, an internationally recognized academic dermatologist and Principal Investigator of the SKNJCT-003 Phase 2 study, will join the company’s leadership team during a business update webcast on March 26, 2026 at 11:30 a.m. Eastern. The call follows the company’s Form 10‑K filing expected after market close on March 25. During the webcast Dr. Rao will provide clinical interpretation and an independent investigator perspective on the recently reported positive dataset from SKNJCT-003.
Dr. Rao is a board‑certified dermatologist, professor and experienced clinical investigator in skin oncology, and serves as Principal Investigator of the randomized, double‑blind SKNJCT‑003 trial testing doxorubicin delivered by the SkinJect microneedle system for nodular basal cell carcinoma. The 200‑µg treatment cohort showed 73% clinical clearance at Day 57—suggesting roughly 3 out of 4 treated lesions might avoid immediate surgery—while the device‑only arm showed biological activity, supporting further development and potential regulatory and partnership discussions.
Read Announcement- Drug:
- SKNJCT-003
- Announced Date:
- March 9, 2026
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma Ltd. today provided additional context regarding the recently reported topline dataset from the Phase 2 SKNJCT-003 study evaluating SkinJect® microneedle delivery of D-MNA and P-MNA for basal cell carcinoma (BCC).
AI Summary
Medicus Pharma reported additional context for the Phase 2 SKNJCT-003 topline dataset evaluating SkinJect microneedle delivery of D‑MNA (active) and P‑MNA (placebo active) for basal cell carcinoma. The 200‑µg treatment cohort showed the strongest signal: 73% clinical clearance and 40% histological clearance at Day 57. Clinical clearance means the lesion disappeared visually; histological clearance means no tumor cells were found on biopsy.
The company highlighted that microneedle insertion itself can cause biological effects—mechanical disruption, wound‑healing and local immune activation—which may produce responses in the P‑MNA arm. Despite that, there was clear separation in clinical response between D‑MNA (73%) and P‑MNA (38%) in the 200‑µg cohort, supporting an additional drug effect from D‑MNA delivered by SkinJect.
Medicus calls the dataset decision‑grade and believes it supports further development, regulatory discussions and potential strategic partnerships. They note the approach could offer a non‑surgical option for many patients, including those with Gorlin Syndrome, if confirmed in future studies.
Read Announcement- Drug:
- SKNJCT-003
- Announced Date:
- March 5, 2026
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma Ltd. is pleased to announce topline results from its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.
AI Summary
Medicus Pharma reported topline results from its Phase 2 SKNJCT-003 study testing Doxorubicin Microneedle Array (D-MNA) to treat nodular basal cell carcinoma (BCC). The randomized, double-blind, placebo-controlled trial enrolled 90 patients and compared placebo (P-MNA) with low-dose (100 µg) and high-dose (200 µg) D-MNA groups. The main goal was combined clinical and histological clearance at prespecified post-treatment timepoints.
Clearance rates rose between Day 29 and Day 57, suggesting ongoing biological activity. At Day 57 the 200 µg cohort showed the strongest effect, with 73% clinical clearance and 40% histological complete response. Medicus says these topline findings are positive and decision-grade, especially at the higher dose.
The company plans to finalize the clinical study report by Q2 2026 and believes the data support an end-of-Phase 2 meeting with the FDA in H1 2026 and enhance partnering readiness, while noting the study was not powered for registrational approval.Read Announcement
- Drug:
- SKNJCT-003
- Announced Date:
- December 15, 2025
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma Ltd. is pleased to announce that its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively treat nodular basal cell carcinoma (BCC) of the skin, has successfully completed enrolment of ninety (90) patients in the United States.
AI Summary
Medicus Pharma Ltd. announced that its Phase 2 study SKNJCT-003 has finished enrolling 90 patients in the United States. The trial is testing the Doxorubicin Microneedle Array (D‑MNA), a dissolvable microneedle patch designed to non‑invasively treat nodular basal cell carcinoma (BCC) of the skin.
SKNJCT-003 is being conducted at nine U.S. clinical sites and is a randomized, double‑blind, placebo‑controlled study. It evaluates two dose levels of D‑MNA against a placebo control to measure safety and efficacy in patients with nodular BCC.
The company expects to release topline results for SKNJCT-003 before the end of Q1 2026 and plans to request an End‑of‑Phase 2 (EOP2) meeting with the FDA in the first half of 2026. Completing enrollment advances development of a potential non‑invasive, patient‑friendly treatment for BCC.
Read Announcement- Drug:
- SKNJCT-003
- Announced Date:
- November 17, 2025
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma Ltd is pleased to announce that it has submitted an FDA Commissioner's national priority voucher (CNPV) application on behalf of Skinject (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.
AI Summary
Medicus Pharma Ltd. has submitted an FDA Commissioner’s National Priority Voucher (CNPV) application on behalf of SkinJect for SKNJCT-003, a clinical program testing a Doxorubicin Microneedle Array (D-MNA) to non‑invasively treat basal cell carcinoma (BCC). The submission includes a Statement of Interest explaining how SkinJect aligns with U.S. health priorities around access, affordability, and rare‑disease needs, and requests inclusion in the pilot CNPV program to enable closer FDA collaboration and faster review to help speed patient access.
SkinJect’s D-MNA is a single‑use, dissolvable microneedle patch that delivers doxorubicin directly into lesions and biodegrades after treatment. The company says this office‑based approach could provide a low‑cost, non‑surgical alternative to Mohs surgery, expand treatment options for elderly or fragile patients, and address the unmet needs of people with Gorlin syndrome who face recurrent BCCs. SKNJCT-003 is an ongoing Phase 2 study evaluating lesion clearance, histologic cure, and tolerability.
Read Announcement- Drug:
- SKNJCT-003
- Announced Date:
- November 13, 2025
- Indication:
- For the Treatment of Nodular Basal Cell Carcinoma
Announcement
Medicus Pharma announce that it has received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.
AI Summary
Medicus Pharma announced it received full regulatory and ethical approvals in the United Kingdom to expand its Phase 2 study SKNJCT-003 testing a Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC). Approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol, the WREC gave a favorable ethical opinion, and the HRA granted study-wide governance approval confirming compliance with U.K. Good Clinical Practice and NHS capacity and capability standards.
D-MNA is a single-use, dissolvable microneedle patch that delivers doxorubicin directly into skin lesions, aiming to offer a non-surgical, office-based alternative to Mohs surgery. Expanding SKNJCT-003 into the U.K. could speed enrollment and help evaluate this lower-cost, minimally invasive approach for common BCC and for patients with Gorlin syndrome who face many recurrent tumors and repeated surgeries.
Read Announcement- 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
Teverelix FDA Regulatory Events
Teverelix is a drug developed by Medicus Pharma for the following indication: Acute Urinary Retention.
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:
- Teverelix
- Announced Date:
- April 15, 2026
- Indication:
- Acute Urinary Retention
Announcement
Medicus Pharma Ltd. announced it will present new Phase 1 clinical data on Teverelix, its investigational long-acting gonadotropin-releasing hormone (GnRH) antagonist, at the American Association of Clinical Endocrinology Annual Meeting 2026 (AACE 2026) on April 22-24th in Las Vegas, Nevada.
AI Summary
Medicus Pharma Ltd. will present new Phase 1 clinical data on Teverelix, its investigational long‑acting GnRH antagonist, at the American Association of Clinical Endocrinology Annual Meeting (AACE 2026) in Las Vegas, April 22–24. Faisal Mehmud, MD, MRCP, the company’s Chief Medical Officer, will present a poster titled “Evaluation of Teverelix, a Long‑Acting GnRH Antagonist: Pharmacokinetics, Pharmacodynamics, Bone Turnover and Safety in Two Phase I Studies in Healthy Female Volunteers” on April 24 at 11:40 AM PT. The poster summarizes two Phase I studies (TEVERELIX HFV1 and HFV2) conducted in Germany that enrolled 48 healthy premenopausal women and evaluated single‑dose subcutaneous administration of Teverelix.
Medicus says these Phase I results give a strong mechanistic and pharmacologic basis for patient studies and support long‑acting dosing strategies across indications. The company is exploring a precision medicine program for symptomatic endometriosis with Omics Labs in the UAE, using genomics to improve patient selection. No long‑acting injectable GnRH antagonists are currently approved for endometriosis, positioning Teverelix as a potential first in this space. See the AACE 2026 abstract for details.
Read Announcement- Drug:
- Teverelix
- Announced Date:
- April 6, 2026
- Indication:
- Acute Urinary Retention
Announcement
Medicus Pharma Ltd. announced the Company has submitted an optimized Phase 2 clinical study design to the U.S. Food and Drug Administration ("FDA") for Teverelix, its investigational GnRH antagonist, for the prevention of recurrent acute urinary retention ("AURr") in men with benign prostatic hyperplasia ("BPH") as part of its existing open Investigational New Drug ("IND") for Teverelix.
AI Summary
Medicus Pharma Ltd. said it has submitted an optimized Phase 2 clinical study design to the U.S. Food and Drug Administration under its existing open IND for Teverelix, an investigational GnRH antagonist, to prevent recurrent acute urinary retention (AURr) in men with benign prostatic hyperplasia. The program is led by urology expert Steven A. Kaplan, MD, FACS. There are currently no approved drugs specifically to prevent AURr, and the company cites an approximate $2 billion target market.
The refined ANT-2111-02 design targets about 126 patients across the U.S. and Europe in a randomized, double-blind, single-dose, four-arm trial to detect a pharmacodynamic signal (total prostate volume reduction) and to optimize dose and route. Arms include Teverelix 90 mg intramuscular, Teverelix 120 mg subcutaneous, and matched placebos. All patients receive one injection on Day 1 and continue standard alpha-blocker therapy.
The 52-week study (28-week treatment, 24-week follow-up) uses percent change in total prostate volume at Week 12 as the primary endpoint. Secondary endpoints include Qmax, post-void residual, AURr events and need for intervention. An interim analysis after ~50% of patients complete Week 12 will inform dose, route and Phase 3 planning by providing an early pharmacodynamic signal.
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:
- October 22, 2025
- Indication:
- To Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)
Announcement
Medicus Pharma is pleased to announce the enrollment of the first patient in United Arab Emirates (UAE) SKNJCT-004 phase 2 clinical study, to non-invasively treat BCC of the skin.
AI Summary
Medicus Pharma Ltd. announced the first patient enrolled in its Phase 2 SKNJCT-004 study in the UAE. The study tests a non-invasive microneedle array to treat basal cell carcinoma (BCC) of the skin. Cleveland Clinic Abu Dhabi is the principal investigator site for the 36-participant trial.
The multi-center study will randomize 36 patients across six UAE sites coordinated by UAE-based IROS. It is randomized, double-blind and placebo-controlled, assigning participants 1:1:1 to a placebo microneedle array (P-MNA), a low-dose group with 100 μg of D-MNA, or a high-dose group with 200 μg.
Dr. Raza Bokhari, the company’s CEO, said enrolling the first BCC patient at Cleveland Clinic Abu Dhabi is a key milestone that expands the study globally. He noted this phase moves the development of non-invasive skin cancer treatments forward in a market worth over US$2 billion.
Read Announcement- Drug:
- SKNJCT-004
- Announced Date:
- September 29, 2025
- Indication:
- To Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)
Announcement
Medicus Pharma Ltd is pleased to announce positive feedback from Type C meeting with United States Food and Drug Administration (FDA).
AI Summary
Medicus Pharma Ltd. announced positive feedback from its FDA Type C meeting on using dissolvable Doxorubicin microneedle arrays (D-MNA) to treat basal cell carcinoma (BCC). The FDA agreed Medicus may follow the 505(b)(2) pathway, unlocking a roughly $2 billion market opportunity.
The FDA clarified that a relative bioavailability study could support a clinical bridge under 21 CFR 320.21. It provided guidance on primary endpoints, patient selection, randomized double-blind placebo-controlled design, and safety assessments. The agency also recommended optimizing the D-MNA formulation, adding an adhesive layer, and using an applicator for consistent application.
Medicus plans to finish patient recruitment for SKNJCT-003 by Q4 2025 and seek an end-of-Phase 2 meeting in Q1 2026. “Establishing the 505(b)(2) pathway is a game changer,” said CEO Dr. Raza Bokhari, citing cost and time savings. The company expects Skinject to be commercially viable by 2027.
Read Announcement- Drug:
- SKNJCT-004
- Announced Date:
- September 8, 2025
- Indication:
- To Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)
Announcement
Medicus Pharma Ltd is pleased to announce that the SKNJCT-004 phase 2 clinical study, to non-invasively treat BCC of the skin, has commenced patient recruitment in Cleveland clinic Abu Dhabi (CCAD). Earlier this year, in May 2025, SKNJCT-004 received "study may proceed" approval from the UAE Department of Health.
AI Summary
Medicus Pharma Ltd. is pleased to announce the SKNJCT-004 Phase 2 clinical study has begun recruiting patients at Cleveland Clinic Abu Dhabi (CCAD). This study evaluates a novel, non-invasive microneedle patch treatment for basal cell carcinoma (BCC) of the skin.
SKNJCT-004 received “study may proceed” approval from the UAE Department of Health in May 2025. The trial plans to enroll 36 patients across multiple UAE centers, including CCAD, Sheikh Shakhbout Medical City, Burjeel Medical City, Rashid Hospital, Clemenceau Medical Center, and American Hospital Dubai. Insights Research Organization and Solutions (IROS) is coordinating the study.
This randomized, double-blind, placebo-controlled trial will compare two dose levels of D-MNA to placebo in a 1:1:1 design. Dr. Raza Bokhari, Medicus’s Executive Chairman & CEO, noted that patient recruitment at CCAD marks a promising step toward offering a first-in-class non-invasive option for BCC treatment.
Read Announcement- 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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