gemcitabine/docetaxel controlled release (NDV-01) / Trigone Pharma, Relmada Therapeutics - LARVOL DELTA

BOOST: A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Relmada Therapeutics, Inc. | N=302 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urethral Cancer • Urothelial Cancer

RESCUE: A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Relmada Therapeutics, Inc. | N=85 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Prospective Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Sustained-Release Gemcitabine Docetaxel combination (NDV-01) in High-Risk NMIBC: Update with 9-month Complete Response Data (AUA 2026) - No abstract available

Clinical • Bladder Cancer

Trial in Progress: REL-NDV01-301 (BOOST) - A Phase 3, Randomized Study of Adjuvant Intravesical Sustained-Release Gemcitabine-Docetaxel (NDV-01) Versus Surveillance for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer (AUA 2026) - No abstract available

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

RESCUE: A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=393 | Not yet recruiting | Sponsor: Relmada Therapeutics, Inc.

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Relmada Therapeutics Reports 12-Month Phase 2 Interim Data for NDV-01 in Non-Muscle Invasive Bladder Cancer (The Manila Times) - "Data reinforces advancement of NDV-01 into Phase 3 RESCUE registrational program in second line (2L) BCG-unresponsive and adjuvant intermediate-risk NMIBC in mid-2026...The Phase 2 trial of NDV-01 demonstrated a 12-month complete response (CR) rate of 76% with a favorable safety profile. Notably, a 12-month CR rate of 80% was achieved in the BCG-unresponsive population, one of the most difficult-to-treat segments of NMIBC...Expected Upcoming NDV-01 Milestones: NDV-01 United States IND clearance - Mid-2026....Initial 3-month results from Phase 3 2L BCG-unresponsive study expected by YE 2026"

IND • P2 data • P3 data • Trial status • Bladder Cancer

Prospective Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Sustained-Release Gemcitabine Docetaxel combination (NDV-01) in High-Risk NMIBC: Update with 6-month Complete Response Data (SUO 2025) - "NDV-01 is a novel sustained formulation of Gem/Doce for intravesical use. NDV-01 provides excellent 6-month safety and efficacy in participants with high-risk NMIBC -- including those who are BCG-naïve, -exposed and -unresponsive. The study remains ongoing to provide longer term follow-up and a larger sample size."

Clinical • Bladder Cancer

PROSPECTIVE OPEN LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVESICAL SUSTAINED RELEASE GEMCITABINE DOCETAXEL COMBINATION (NDV-01) IN HIGH RISK NMIBC (AUA 2025) - P2 | "The proportion of patients achieving primary and secondary endpoints will be reported with an exact 95% CI for the proportion. Kaplan-Meier methods will be used to provide estimates of median duration and of the probability of duration at 3 months intervals."

Clinical • Bladder Cancer

RESCUE: A Phase 3 Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy (clinicaltrials.gov) - P3 | N=85 | Not yet recruiting | Sponsor: Relmada Therapeutics, Inc.

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

BOOST: A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT (clinicaltrials.gov) - P3 | N=302 | Not yet recruiting | Sponsor: Relmada Therapeutics, Inc.

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urethral Cancer • Urothelial Cancer

Relmada Therapeutics Announces Presentation of NDV-01 Phase 2 Data at the Society for Urologic Oncology (The Manila Times) - "'We are on track to initiate the Phase 3 program in H1 2026, building on the encouraging, recently announced 9-month data, showing a 92% complete response (CR) rate at any time point, and encouraging recent FDA discussions, which provide us with a well-defined registrational strategy in two distinct indications in NMIBC with limited treatment options.'"

New P3 trial • P2 data • Bladder Cancer

Relmada Therapeutics…Provides Key Clinical, Regulatory, and Corporate Updates (GlobeNewswire) - "Expected Upcoming Milestones: (i) NDV-01 Twelve-month data from ongoing Phase 2 NMBIC Study - Q1 2026; (ii) NDV-01 United States IND clearance - 1st Half 2026; (iii) NDV-01 High-risk, 2nd line BCG-unresponsive NMIBC Phase 3 Trial Initiation - 1st Half 2026; (iv) NDV-01 Intermediate Risk in the Adjuvant Setting Phase 3 Trial Initiation - 1st Half 2026."

IND • New P3 trial • P2 data • Bladder Cancer

Relmada announced 9-month follow-up data from the Phase 2 study of NDV-01 in non-muscle invasive bladder cancer. (The Manila Times) - "Highlights of the 9-month follow-up data and updated 3-month and 6-month data from the Phase 2 study of NDV-01: Two subjects have reached 12-month assessment, and both have a CR; No patient had progression to muscle invasive disease; No patient underwent a radical cystectomy; No new safety signals in terms of type, number, or degree of AEs - with no patients having a >= Grade 3 TRAE and no patients discontinued treatment due to AEs"

P2 data • Bladder Cancer

Relmada Announces FDA Feedback Supporting 2 Separate Acceptable Registrational Study Paths for NDV-01 in Non-muscle Invasive Bladder Cancer (The Manila Times) - "Relmada Therapeutics, Inc...announced the receipt of written minutes from a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3 program for NDV-01 in non-muscle invasive bladder cancer (NMIBC) patients...The Company will be requesting follow-up meetings with FDA to discuss each development path. Relmada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDV-01, expected to begin in H1 2026"

FDA event • New P3 trial • Bladder Cancer

Relmada Therapeutics...Announces NDV-01 6-Month Follow-up Safety and Efficacy Data in NMIBC (GlobeNewswire) - P2 | N=70 | NCT06663137 | Sponsor: Relmada Therapeutics, Inc. | "6-month follow-up for NDV-01 showed a 91% overall response rate at any time in non-muscle invasive bladder cancer, with good overall safety...Enrollment in the Phase 2 study for NDV-01 continues, with updates expected at 9 and 12 month data follow-up. Preparations underway to start Phase III registration trial in 1H 2026...FDA interactions and product supply scale-up in 2H 2025."

Commercial • New P3 trial • P2 data • Bladder Cancer

Relmada Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Pipeline Highlights: NDV-01:...Next Steps: (i) FDA interactions and product supply scale-up in 2H 2025; (ii) Initiation of Phase 3 registration-track study in 1H 2026....The Phase 2 study for NDV-01 continues with updates at 6, 9 and 12 month data follow-up over the course of 2025."

FDA event • New P3 trial • P2 data • Bladder Cancer

Relmada Therapeutics Presents Positive Initial Phase 2 NDV-01 Data at AUA2025 (GlobeNewswire) - P2 | N=70 | NCT06663137 | Sponsor: Trigone Pharma Ltd. | "Highlights of Phase 2 data presented at AUA2025: Efficacy Data: (i) 3-month Assessment: Overall Response Rate (ORR): 85% (17/20 patients at 3 months); High-Grade Recurrence-Free Survival (HGRFS) in papillary disease: 83.3% (15/18 patients); Complete Response (CR) in CIS patients: 100% (2/2 patients); (ii) At any time point: ORR: 90% (18/20 patients); HGRFS in papillary disease: 88.8% (16/18 patients); CR in CIS patients: 100% (2/2 patients); (iii) Disease status at 6 months: 100% (n=7) of evaluable patients (1 CIS, 6 Ta/T1) achieved disease free status. One of these patients was re-treated at 3 months."

P2 data • Bladder Cancer

Relmada Therapeutics to Host KOL Event on Phase 2 NDV-01 Data (GlobeNewswire) - "The event will feature Boris Chertin, MD (Department of Urology, Shaare Zedek Medical Center) and Yair Lotan, MD (UT Southwestern Medical Center), who will join Relmada’s management to discuss topline efficacy and safety data from the Phase 2 study evaluating NDV-01 for the treatment of high-grade non-muscle invasive bladder cancer (HG-NMIBC). The data will be presented at the American Urological Association meeting (AUA), on April 28, 2025 in Las Vegas, Nevada."

P2 data • Bladder Cancer

Relmada Therapeutics To Present NDV-01 Data at AUA2025 (GlobeNewswire) - "Relmada Therapeutics, Inc...announced the presentation of an abstract at the American Urology Association (AUA2025), taking place from April 26-29th in Las Vegas."

P2 data • Bladder Cancer

UPDATE -- Relmada Therapeutics To Present NDV-01 Data at AUA2025 (GlobeNewswire) - "Data to be presented on Monday, April 28, 2025...Relmada Therapeutics...announced the presentation of an abstract at the American Urology Association (AUA2025), taking place from April 26-29th in Las Vegas."

Trial status • Bladder Cancer

Relmada Therapeutics Licenses Phase 2 Bladder Cancer Candidate, NDV-01, from Trigone Pharma, Ltd. (GlobeNewswire) - "Relmada Therapeutics, Inc...announced the completion of an exclusive licensing agreement with Trigone Pharma, Ltd. (Trigone) for NDV-01, a novel sustained-release intravesical formulation of gemcitabine and docetaxel (gem/doce) for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). The efficacy and safety of the NDV-01 are being evaluated in a Phase 2 study. First data are expected to be reported at the American Urological Association meeting (AUA), being held April 26-29, 2025 in Las Vegas."

Licensing / partnership • P2 data • Bladder Cancer

Relmada Therapeutics Reports Fourth Quarter and Full Year 2024 Results and Provides Business Update (GlobeNewswire) - "Upcoming Milestones: NDV-01: (i) Topline Phase 2 data: Expected to be reported at the American Urological Association meeting (AUA), being held April 26-29, 2025 in Las Vegas; (ii) Phase 2 preparations, including planned FDA interactions and manufacturing: Q2-Q4 2025; (ii) Initiation of registration-track study: late Q4 2025 to early 2026."

FDA event • New trial • P2 data • Bladder Cancer