This section highlights FDA-related milestones and regulatory updates for drugs developed by Relmada Therapeutics (RLMD).
Over the past two years, Relmada Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NDV-01, REL-1017, and REL-1017. 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.
NDV-01 FDA Regulatory Timeline and Events
NDV-01 is a drug developed by Relmada Therapeutics for the following indication: For Non-Muscle Invasive Bladder Cancer.
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:
- NDV-01
- Announced Date:
- May 5, 2026
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
Relmada Therapeutics, announced the presentation of two abstracts related to NDV-01 at the American Urology Association (AUA2026), taking place from May 15-18th in Washington D.C.
AI Summary
Relmada Therapeutics announced it will present two abstracts on NDV-01 at the American Urology Association meeting (AUA2026) in Washington, D.C., May 15–18, 2026. A 12-month Phase 2 data update in high‑risk non‑muscle invasive bladder cancer (NMIBC) will be presented on Friday, May 15; the poster abstract notes an update including 9‑month complete response data. A Phase 3 overview will be presented as a Trials‑in‑Progress oral session on Sunday, May 17.
The Phase 2 poster (IP02-03) is scheduled for the IP02: Bladder Cancer: Non‑Invasive session in Room 146A at the Walter E. Washington Convention Center on Friday, May 15 from 7:00–9:00 AM ET. The Phase 3 oral (REL-NDV01-301, BOOST) is in the Clinical Trials in Progress: Bladder Cancer session in Hall B, The Square Learning Lab on Sunday, May 17 from 9:56–10:04 AM ET. Times and locations may change.
The Phase 3 "RESCUE" registrational program is on track to start mid‑2026. NDV-01 is an intravesical sustained‑release gemcitabine‑docetaxel combination being developed for NMIBC. Relmada is a clinical‑stage biotech advancing NDV-01 and sepranolone in mid‑stage development.
Read Announcement- Drug:
- NDV-01
- Announced Date:
- March 9, 2026
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
Relmada Therapeutics, Inc announced 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).
AI Summary
Relmada Therapeutics reported 12-month interim results from its Phase 2 study of NDV-01 in patients with high‑risk non‑muscle invasive bladder cancer (NMIBC). The study showed a durable 76% complete response (CR) rate at 12 months and a 95% CR rate at any time in the overall high‑risk population. In the BCG‑unresponsive subgroup, NDV‑01 achieved an 80% CR rate at 12 months and a 94% CR rate at any time.
Tolerability was favorable: there were no treatment‑related adverse events of Grade 3 or higher and no treatment‑related discontinuations. Relmada said these data support advancing NDV‑01 into the Phase 3 RESCUE registrational program for second‑line BCG‑unresponsive and adjuvant intermediate‑risk NMIBC, with plans to initiate the program around mid‑2026. The results suggest strong activity and a good safety profile in this difficult‑to‑treat population.
Read Announcement- Drug:
- NDV-01
- Announced Date:
- January 12, 2026
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
Relmada Therapeutics, announced that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding the registrational development pathway for NDV-01 in 2nd-line refractory, high-grade BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) -- one of the highest-risk and most treatment-resistant NMIBC populations -- and in intermediate risk NMIBC in the adjuvant setting, where there are currently no approved therapies.
AI Summary
Relmada Therapeutics received written FDA feedback on the registrational pathway for NDV-01 in two NMIBC settings: 2nd-line refractory, high-grade BCG-unresponsive disease with carcinoma in situ (CIS), and intermediate-risk NMIBC in the adjuvant setting. The FDA indicated a single-arm, open-label trial is an appropriate registrational approach for the high-grade CIS population. For intermediate-risk adjuvant disease, the FDA supported a single registrational, open-label trial randomized to NDV-01 versus observation.
The company expects to start the Phase 3 program in the first half of 2026. The planned high-grade study will use complete response (CR) rate at any time as the primary endpoint, with duration of response (DOR) as a key secondary endpoint; assessments will include cystoscopy, cytology, and biopsy. The intermediate-risk study will use disease-free survival (DFS) as the primary endpoint, with DOR as a key secondary endpoint and similar assessments.
NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel designed to retain drug in the bladder for about ten days. It aims to be a convenient, in-office, bladder-sparing option with increased local exposure and limited systemic toxicity for patients with limited approved treatments.
Read Announcement- Drug:
- NDV-01
- Announced Date:
- December 3, 2025
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
Relmada Therapeutics, announced that the previously disclosed 6-month follow-up data from the ongoing Phase 2 study of NDV-01, a sustained release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for non-muscle invasive bladder cancer (NMIBC) will be presented in a poster at the Society of Urologic Oncology 26th Annual Meeting (SUO 2025).
AI Summary
Relmada Therapeutics said 6‑month follow‑up data from its ongoing Phase 2 study of NDV‑01 will be presented in a poster at the Society of Urologic Oncology 26th Annual Meeting (SUO 2025). Poster #143 will be presented by Yair Lotan, MD, on Thursday, December 4 at 2:30 PM MT in Phoenix. The poster highlights favorable overall safety from the 6‑month follow‑up of NDV‑01 in non‑muscle invasive bladder cancer (NMIBC).
NDV‑01 is a sustained‑release, intravesical formulation of gemcitabine and docetaxel designed to retain drugs in the bladder and release them over about 10 days. It creates a soft matrix for local exposure, is ready to use, can be given in office in under 10 minutes without anesthesia, and is patent‑protected through 2038. Relmada plans to advance NDV‑01 into Phase 3 studies in two NMIBC indications in H1 2026, targeting high‑ and intermediate‑risk patients who make up roughly 80% of new NMIBC cases (about 54,000 people/year in the U.S.).
The Phase 2 trial is an open‑label, single‑arm study with biweekly induction and monthly maintenance up to one year. A copy of the poster will be posted on Relmada’s website after the session.
Read Announcement- Drug:
- NDV-01
- Announced Date:
- November 4, 2025
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
Relmada Therapeutics 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.
AI Summary
Relmada Therapeutics announced it received written minutes from a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its planned Phase 3 program of NDV-01 in non-muscle invasive bladder cancer (NMIBC) patients. FDA feedback supports two potential registrational trials: a single-arm trial in high-grade, second-line, BCG-unresponsive NMIBC and a randomized controlled trial in intermediate-risk NMIBC after TURBT, comparing adjuvant NDV-01 with observation.
The FDA indicated that these study designs, including a time-to-event endpoint in the randomized trial, are generally acceptable and that no additional non-clinical studies are required to support a 505(b)(2) New Drug Application. Relmada plans to request follow-up meetings to refine each development path. This alignment clears a path toward initiating the Phase 3 pivotal studies for NDV-01 in the first half of 2026.
Read Announcement- Drug:
- NDV-01
- Announced Date:
- April 28, 2025
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
Relmada Therapeutics, announced that positive initial data from the Phase 2 study of NDV-01 showed that 90% of patients achieved high-grade disease-free status at any time point following treatment, demonstrating strong clinical activity and supporting further development of NDV-01 for the treatment of non-muscle invasive bladder cancer (NMIBC).
AI Summary
Relmada Therapeutics recently reported promising results from their Phase 2 study of NDV-01, a sustained-release GEM/DOCE formulation for non-muscle invasive bladder cancer (NMIBC). The study showed that 90% of patients reached high-grade disease-free status at some point after treatment. This strong clinical activity was observed in both BCG-naïve and BCG-unresponsive patients, supporting further development of NDV-01 as a potential bladder-sparing therapy.
Early data also noted an 85% overall response rate at three months, along with favorable tolerability and a fast administration time of less than 10 minutes. The positive proof-of-concept demonstrated by NDV-01 suggests it may simplify administration and improve patient outcomes, positioning the treatment as a promising option for NMIBC management in outpatient settings.
Read Announcement- Drug:
- NDV-01
- Announced Date:
- April 27, 2025
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
Relmada Therapeutics, announced the presentation of an abstract at the American Urology Association (AUA2025), taking place from April 26-29th in Las Vegas.
AI Summary
Relmada Therapeutics announced it will present an abstract at the American Urology Association conference (AUA2025) in Las Vegas from April 26-29, 2025. The presentation is scheduled for April 28, 2025, from 10:04 AM to 10:12 AM PT in Hall C at The Square Learning Lab. The abstract, titled “Prospective Open Label Study to Evaluate the Safety and Efficacy of intravesical sustained release Gemcitabine Docetaxel combination (NDV-01) in High Risk NMIBC,” will cover a clinical trial focused on treating high-grade non-muscle invasive bladder cancer (NMIBC). NDV-01 is a new, in-office treatment that releases chemotherapy agents steadily over 10 days, aiming to improve efficacy while reducing side effects. This research may offer a promising new therapy option for NMIBC patients, especially those who have not responded well to existing treatments.
Read Announcement- Drug:
- NDV-01
- Announced Date:
- April 24, 2025
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
Relmada Therapeutics, announced it will host a virtual key opinion leader (KOL) event on Monday, April 28, 2025 at 4:30 PM ET.
AI Summary
Relmada Therapeutics announced a virtual key opinion leader (KOL) event scheduled for Monday, April 28, 2025, at 4:30 PM ET. The event will bring together top urology experts, including Boris Chertin, MD, and Yair Lotan, MD, alongside the company’s management team. They will discuss the topline efficacy and safety data from the Phase 2 study of NDV‑01, an innovative intravesical therapy designed for high-grade non-muscle invasive bladder cancer (HG-NMIBC). NDV‑01 is a sustained-release formulation that combines gemcitabine and docetaxel and may offer a new treatment option for patients, especially those who have not responded to other treatments. Medical professionals and interested parties can register for the event to view the detailed study findings and participate in a live question and answer session following the formal presentation.
Read Announcement- Drug:
- NDV-01
- Announced Date:
- April 14, 2025
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
Relmada Therapeutics, announced the presentation of an abstract at the American Urology Association (AUA2025), taking place from April 26-29th in Las Vegas.
AI Summary
Relmada Therapeutics announced it will present an abstract at the American Urology Association (AUA2025) conference in Las Vegas from April 26–29, 2025. The abstract, titled “Prospective Open Label Study to Evaluate the Safety and Efficacy of intravesical sustained release Gemcitabine Docetaxel combination (NDV-01) in High Risk NMIBC: P2,” will be given on April 28 at 10:04 AM PT during a session known as "Paradigm-Shifting."
The presentation will focus on NDV-01, an investigational formulation that combines gemcitabine and docetaxel into a sustained-release therapy intended for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Designed for intravesical dosing, NDV-01 is created to gradually release medication over approximately ten days, potentially improving patient outcomes with reduced side effects and better drug efficiency. This study is part of the Phase 2 research efforts as the company explores new treatment options for NMIBC patients.
Read Announcement- Drug:
- NDV-01
- Announced Date:
- March 27, 2025
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
Relmada Therapeutics, Inc. provided a corporate update
AI Summary
Relmada Therapeutics, Inc. provided a corporate update highlighting progress with their clinical pipeline. The company plans to present topline Phase 2 data for NDV-01, a new sustained-release formulation of gemcitabine and docetaxel, aimed at treating high-grade non-muscle invasive bladder cancer. Topline data are expected to be shared at the American Urological Association meeting in April 2025.
Additionally, Relmada is advancing its neurosteroid sepranolone towards a Phase 2b study for Tourette syndrome, with plans to explore its use in other compulsion-related disorders, including Prader-Willi Syndrome. The corporate update emphasized these strategic development efforts as key value drivers for the company, while also noting a strong cash balance of $44.8 million as of December 31, 2024.
Read Announcement- Drug:
- NDV-01
- Announced Date:
- March 25, 2025
- Indication:
- For Non-Muscle Invasive Bladder Cancer
Announcement
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).
AI Summary
Relmada Therapeutics recently completed an exclusive licensing agreement with Trigone Pharma for NDV-01, a new sustained‐release intravesical formulation that combines gemcitabine and docetaxel. This innovative treatment is designed for patients with non-muscle invasive bladder cancer (NMIBC) and offers a prolonged drug release over a 10-day period, potentially providing more consistent treatment exposure and improved clinical outcomes. The formulation aims to simplify dosing by being ready for in-office use, which could lead to better patient compliance and reduced side effects compared to traditional therapies. Under the agreement, Relmada will make an upfront payment, issue common stock shares, and is set to pay further development, regulatory, and sales milestones, along with royalties on net sales. Following the Phase 2 evaluation of NDV-01, Relmada will take charge of its development, manufacturing, and commercialization efforts.
Read Announcement
REL-1017 Reliance II FDA Regulatory Events
REL-1017 Reliance II is a drug developed by Relmada Therapeutics for the following indication: For major depressive disorder (MDD).
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:
- REL-1017 Reliance II
- Announced Date:
- December 9, 2024
- Indication:
- For major depressive disorder (MDD)
Announcement
Relmada Therapeutics, announced that in light of the recent data monitoring committee (DMC) evaluation of the full dataset from the Reliance II Phase 3 study of the Company's REL-1017 program, the Company will discontinue the Reliance II and Relight Phase 3 studies.
AI Summary
Relmada Therapeutics has announced that following a full dataset review by the data monitoring committee for the Reliance II Phase 3 study of its REL-1017 program, the company will discontinue both the Reliance II and Relight Phase 3 studies. This decision was made after evaluating the study data, which led the company to stop these Phase 3 trials. Relmada will, however, continue with its Phase 1 first-in-human study of REL-P11, which is aimed at treating metabolic disease.
Along with this decision, the company is exploring different strategic alternatives to increase shareholder value. This may include options such as selling company assets, merging with another company, or other similar transactions, although no specific plan or timeline has been set at this time.
Read Announcement- Drug:
- REL-1017 Reliance II
- Announced Date:
- December 4, 2024
- Indication:
- For major depressive disorder (MDD)
Announcement
Relmada Therapeutics, announced that the pre-planned interim analysis of Reliance II, conducted by the Independent Data Monitoring Committee (DMC), indicated that the Reliance II Phase 3 study is futile and is unlikely to meet the primary efficacy endpoint with statistical significance.
AI Summary
Relmada Therapeutics announced that the pre-planned interim analysis of its Reliance II Phase 3 study showed the trial is futile. An Independent Data Monitoring Committee reviewed the study, which tests REL-1017 as an add-on treatment for major depressive disorder, and found it is unlikely to reach the primary efficacy endpoint with statistical significance. Despite this setback, no new safety concerns were reported. The company expressed disappointment in the initial results and stated that it will thoroughly evaluate the full data before deciding on the future of the REL-1017 program.
Meanwhile, Relmada continues to develop REL-P11 for the treatment of metabolic diseases. The company remains well-capitalized with over $54 million in cash and cash equivalents as of September 30, 2024, ensuring continued progress on its other clinical and research initiatives.
Read Announcement
REL-1017 FDA Regulatory Events
REL-1017 is a drug developed by Relmada Therapeutics for the following indication: For the adjunctive treatment of major depressive disorder (MDD).
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:
- REL-1017
- Announced Date:
- June 18, 2024
- Indication:
- For the adjunctive treatment of major depressive disorder (MDD).
Announcement
Relmada Therapeutics, Inc announced the publication of REL-1017 clinical data from the Reliance I Study in the peer-reviewed journal, The Journal of Clinical Psychiatry.
AI Summary
Relmada Therapeutics, Inc. recently announced the publication of clinical data from its Reliance I Study in The Journal of Clinical Psychiatry. The study evaluated REL-1017, a novel NMDA receptor channel blocker, by testing its use as an adjunct treatment for major depressive disorder in patients who did not respond adequately to standard antidepressants. The Phase 3, randomized, double-blind, placebo-controlled trial examined both the safety and the effectiveness of REL-1017. Results showed promising improvements in patient response rates, especially in those with severe depression, and the side effect profile was found to compare favorably with other approved treatments. This publication builds on earlier research and supports the potential of REL-1017 as a rapid-acting, oral antidepressant that could offer a new treatment option in the fight against depression.
Read Announcement
