teverelix trifluoroacetate / Medicus Pharma - LARVOL DELTA

Medicus Pharma Receives FDA “Study May Proceed” Clearance For Teverelix Phase 2b Study in Advanced Prostate Cancer Patients with High Cardiovascular Risk (Medicus Pharma Press Release) - "The Phase 2b study is an open-label trial enrolling 40 men with advanced prostate cancer appropriate for androgen deprivation therapy (ADT)...Participants will receive: A loading regimen of 180 mg intramuscular (IM) plus two 180 mg subcutaneous (SC) injections (total 540 mg), followed by; Two 180 mg SC injections (360 mg total) on Day 29 and every six weeks thereafter Total treatment duration is approximately 22 weeks...The primary endpoint is confirmation of medical castration by Day 29 with sustained suppression through Day 155, with a target probability exceeding 90%."

IND • New P2b trial • Prostate Cancer

Medicus Pharma Ltd…is pleased to announce that it has received “study may proceed” clearance from the U.S. Food and Drug Administration (FDA) to initiate its Phase 2b dose-optimization study of Teverelix, an investigational next generation long-acting GnRH antagonist, in men with advanced prostate cancer (APC). (GlobeNewswire) - "The Phase 2b study is an open-label trial enrolling 40 men with advanced prostate cancer appropriate for androgen deprivation therapy (ADT)....The planned Phase 2b study is designed to evaluate durability of testosterone suppression, degree and consistency of FSH suppression, and cardiovascular safety. The study is intended to enable a registrational Phase 3 development pathway aligned with prior FDA guidance."

IND • New P2b trial • Prostate Cancer

Medicus Pharma Ltd. Announces Amendment to LifeArc License Improving Teverelix Long-Term Economic and Development Profile (GlobeNewswire) - "Under the amended agreement, the royalty rate payable on worldwide net sales of Teverelix has been reduced from ~4% to 2%, with the royalty term clarified on a country-by-country basis in line with standard industry practice. The amendment does not alter the scope of the license, the underlying intellectual property, or the respective development responsibilities of the parties, and all other terms of the original agreement remain in full force and effect....Under the license framework, all program-specific improvements and enhancements developed by Medicus, and its affiliates are owned by Medicus, supporting continued expansion of the Teverelix intellectual property estate and long-term value creation."

Licensing / partnership • Prostate Cancer

Medicus Pharma Ltd. Announces Engagement With Reliant AI to Develop Artificial Intelligence (AI) Driven Clinical Data Analytics Platform (Medicus Pharma Press Release) - "The platform is expected to support more efficient trial execution, including dynamic clinical-site selection, patient stratification, and enrollment forecasting....Subject to execution of definitive agreements, the data analytics platform is expected to be initially deployed to support a Medicus-sponsored study planned for Q2-Q4 2026, with potential expansion to a larger, late-stage clinical study planned for 2028 in collaboration with a development or commercial partner."

Commercial • New trial • Prostate Cancer

Mechanism of Self-Assembly of the Gonadropin Releasing Hormone Antagonist Teverelix into Amyloid Fibrils. (PubMed, Mol Pharm) - "Interestingly, the fibrils can, under certain conditions, align to create a highly ordered array. To the best of our knowledge, this is the first paper studying teverelix in detail from a biophysical perspective, and it is directly relevant to the aggregation of the peptide observed in vivo."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Medicus Pharma Ltd. To Present at Brookline Capital Markets (ACCESS Newswire) - "Following a company overview from Dr. Raza Bokhari Executive Chairman and CEO of Medicus Pharma, there will be two featured presentations providing updates on the Company's key development programs: Ed Brennan, MD, FACS Chief Scientific Officer & Head of R&D Program, will discuss SkinJect D-MNA novel treatment to non-invasively treat basal cell carcinoma (BCC) of the skin and provide an update on the progress of phase 2 clinical studies; Faisal Mehmud, MD, MRCP, Chief Medical Officer, will provide an update on Teverelix, a next generation GnRH antagonist as a first in class market product to prevent relapse of acute urinary retention (AURr) and high CV risk prostate cancer."

Clinical • Trial status • Basal Cell Carcinoma • Prostate Cancer

Medicus Pharma Ltd Announces a Definitive Agreement to Acquire Antev Ltd. UK (Medicus Pharma Press Release) - "Medicus Pharma...and Antev...announced today that they have entered into a definitive agreement dated June 29, 2025 (the 'Definitive Agreement') pursuant to which Medicus has agreed to acquire all of the issued and outstanding shares of Antev (the 'Antev Shares') on a share exchange basis (the 'Transaction'). Subject to the closing conditions noted in the Definitive Agreement, Medicus will acquire all issued and outstanding Antev Shares, on a fully diluted basis, in exchange for 2,666,600 (or approximately 17% in aggregate) of the issued and outstanding Medicus common shares (the 'Consideration Shares')....Antev is a clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention (AURr) episodes due to enlarged prostate."

M&A • Prostate Cancer

Teverelix is a potential treatment option for the prevention of acute urinary retention recurrence in men suffering from benign prostatic hyperplasia. (PubMed, Int Urol Nephrol) - "Teverelix shows potential as an effective, well-tolerated treatment for LUTS secondary to BPH, with rapid and sustained benefits. The significant prostate volume reduction suggests that teverelix may help prevent recurrent AUR, warranting further dedicated studies."

Clinical • Journal • Benign Prostatic Hyperplasia

A Model-Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk. (PubMed, Clin Pharmacol Drug Dev) - "Model simulation showed that a loading dose of 360 mg SC and 180 mg IM with a maintenance dose of 360 mg SC 6-weekly (Q6W) starting at day 28 can achieve a ≥95% castration rate up to 52 weeks. This dose regimen was selected for phase 3 clinical development, which includes cardiovascular safety assessment in comparison to a GnRH agonist."

Journal • Metastases • P3 data • Benign Prostatic Hyperplasia • Cardiovascular • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy, tolerability, and safety of teverelix DP in patients with advanced prostate cancer: A multicenter, open-label, phase 2 trial. (PubMed, Prostate) - "Overall, the teverelix DP doses were generally well-tolerated but did not adequately maintain castration levels."

Journal • Metastases • P2 data • Dermatology • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety, Pharmacokinetic and Pharmacodynamic Evaluation of Teverelix for the Treatment of Hormone-Sensitive Advanced Prostate Cancer: Phase 2 Loading-Dose-Finding Studies. (PubMed, Medicina (Kaunas)) - "Castrate levels of testosterone can be rapidly achieved following the subcutaneous injection of teverelix DP on 3 consecutive days. Streamlining of the administration of the loading dose and identifying a suitable maintenance dose will be investigated in future trials."

Clinical • Journal • Metastases • P2 data • PK/PD data • Cardiovascular • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Antev Receives US FDA Guidance on Teverelix Phase 3 Trial Design for Treating Advanced Prostate Cancer Patients with Increased Cardiovascular Risk (GlobeNewswire) - "Antev Ltd...announces that the US Food & Drug Administration (FDA) has provided written guidance on the company's proposed Phase 3 pivotal trial design....Antev's Scientific Adviser, Dr Neal Shore MD...said, 'There is an unmet medical need for a new specific 'cardio-oncology' indication for androgen deprivation therapy which will effectively treat the patient's cancer while not worsening cardiovascular safety. This proposed Phase 3 trial is designed to provide the level one evidence that this GnRH antagonist could be the treatment of choice for prostate cancer patients with cardiovascular risks.'"

Media quote • Regulatory

Antev Receives US FDA Guidance on Teverelix Phase 3 Trial Design for Treating Advanced Prostate Cancer Patients with Increased Cardiovascular Risk (GlobeNewswire) - "Antev Ltd...announces that the US Food & Drug Administration (FDA) has provided written guidance on the company’s proposed Phase 3 pivotal trial design....Antev’s proposed ANT-1111-04 is a global Phase 3 trial in up to 1,500 advanced prostate cancer patients with increased CV risk with a 1:1 randomization against standard of care (GnRH agonist) that aims to read out by 2027."

Clinical protocol • P3 data: top line • Genito-urinary Cancer • Oncology • Prostate Cancer

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: Antev Ltd. | Suspended ➔ Completed | Trial completion date: Sep 2023 ➔ Feb 2023

Metastases • Trial completion • Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2 | N=69 | Suspended | Sponsor: Antev Ltd. | Recruiting ➔ Suspended | Trial primary completion date: Apr 2023 ➔ Dec 2022

Metastases • Trial primary completion date • Trial suspension • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2 | N=69 | Recruiting | Sponsor: Antev Ltd. | Trial completion date: Mar 2023 ➔ Sep 2023 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=69; Recruiting; Sponsor: Antev Ltd.; Active, not recruiting ➔ Recruiting; N=20 ➔ 69; Trial completion date: Feb 2022 ➔ Mar 2023; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Pharmacokinetic, Safety, and Pharmacodynamic Properties of Teverelix Trifluoroacetate, a Novel Gonadotropin-Releasing Hormone Antagonist, in Healthy Adult Subjects. (PubMed, Clin Pharmacol Drug Dev) - "Teverelix maximum concentration and exposure increased in an approximately dose-proportional manner across the 60 to 120 mg SC doses. All 3 pharmacodynamic end points (luteinizing hormone, follicle-stimulating hormone, and total testosterone) showed reductions that were more prolonged following the 90 mg IM administration compared to 90 mg SC administration."

Clinical • Journal • PK/PD data • Endometriosis • Genito-urinary Cancer • Gynecology • Oncology • Prostate Cancer • Solid Tumor • Uterine Cancer • Uterine Leiomyoma

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=20; Active, not recruiting; Sponsor: Antev Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Antev Ltd.; Not yet recruiting ➔ Recruiting; Trial completion date: Nov 2021 ➔ Feb 2022; Trial primary completion date: May 2021 ➔ Dec 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Antev Ltd.

Clinical • New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor