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Last Updated: January 20, 2025

Investigational Drug Information for REL-1017


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What is the development status for investigational drug REL-1017?

REL-1017 is an investigational drug.

There have been 9 clinical trials for REL-1017. The most recent clinical trial was a Phase 2 trial, which was initiated on April 1st 2021.

The most common disease conditions in clinical trials are Depressive Disorder, Major, Depressive Disorder, and Depression. The leading clinical trial sponsors are Relmada Therapeutics, Inc., Mauro Manconi, and INC Research.

There are seven hundred and sixty-three US patents protecting this investigational drug and zero international patents.

Recent Clinical Trials for REL-1017
TitleSponsorPhase
Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDDRelmada Therapeutics, Inc.Phase 3
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)Relmada Therapeutics, Inc.Phase 3
Open Label Study to Assess the Safety of REL-1017 for Major Depressive DisorderRelmada Therapeutics, Inc.Phase 3

See all REL-1017 clinical trials

Clinical Trial Summary for REL-1017

Top disease conditions for REL-1017
trials01122334455667Depressive Disorder, MajorDepressive DisorderDepressionNeuralgia[disabled in preview]
Top clinical trial sponsors for REL-1017
trials012345678Relmada Therapeutics, Inc.Mauro ManconiINC Research[disabled in preview]

See all REL-1017 clinical trials

US Patents for REL-1017

DrugnamePatent NumberPatent TitlePatent AssigneeEstimated Expiration
REL-1017 ⤷  Subscribe Therapeutic approaches for treating Parkinson's disease Pharnext (Issy les Moulineaux, FR) ⤷  Subscribe
REL-1017 ⤷  Subscribe Benzimidazole derivatives as ERBB tyrosine kinase inhibitors for the treatment of cancer Capella Therapeutics, Inc. (San Diego, CA) ⤷  Subscribe
REL-1017 ⤷  Subscribe Inhalable pharmaceutical compositions iCeutica Pty Ltd. (Iluka, WA, AU) ⤷  Subscribe
REL-1017 ⤷  Subscribe Powder filling processes Adamis Pharmaceuticals Corporation (San Diego, CA) ⤷  Subscribe
REL-1017 ⤷  Subscribe 2-amino-6-methy1-4,4a,5,6-tetrahydropyrano[3,4-d][1,3]thiazin-8a(8H)-yl-1,- 3-thiazol-4-yl amides Pfizer Inc. (New York, NY) ⤷  Subscribe
REL-1017 ⤷  Subscribe Compositions and methods for treating cancers CEDARS-SINAI MEDICAL CENTER (Los Angeles, CA) ⤷  Subscribe
>Drugname>Patent Number>Patent Title>Patent Assignee>Estimated Expiration
Showing 1 to 6 of 6 entries

International Patents for REL-1017

DrugnameCountryDocument NumberEstimated ExpirationRelated US Patent
REL-1017 Australia AU2012222348 2031-03-01 ⤷  Subscribe
REL-1017 Australia AU2012222351 2031-03-01 ⤷  Subscribe
REL-1017 Australia AU2013224959 2031-03-01 ⤷  Subscribe
REL-1017 Australia AU2013224960 2031-03-01 ⤷  Subscribe
REL-1017 Australia AU2014314055 2031-03-01 ⤷  Subscribe
REL-1017 Australia AU2017210501 2031-03-01 ⤷  Subscribe
>Drugname>Country>Document Number>Estimated Expiration>Related US Patent
Showing 1 to 6 of 6 entries

Development Update and Market Projection for REL-1017

Introduction to REL-1017

REL-1017, developed by Relmada Therapeutics, is a novel chemical entity (NCE) and a unique NMDA receptor (NMDAR) channel blocker. It is designed to target hyperactive NMDA channels while preserving normal glutamatergic neurotransmission, making it a promising candidate for the treatment of major depressive disorder (MDD)[2][4].

Mechanism of Action

REL-1017 works by selectively blocking overactive NMDA channels, which is crucial for its therapeutic effects. This mechanism allows for rapid and sustained antidepressant effects without disrupting physiological neurotransmission. This approach is distinct and offers a new avenue for treating MDD, differentiating it from existing treatments[2][4].

Clinical Trials and Development Status

Phase II Trials

In Phase II trials, REL-1017 demonstrated rapid, strong, and lasting antidepressant effects, with statistically significant improvements over placebo. These trials also highlighted the drug's favorable safety, tolerability, and pharmacokinetic profile[2].

Phase III Trials

REL-1017 is currently in late-stage development, with several Phase III trials underway. The Reliance I Study, published in June 2024, provided positive clinical data. Two other Phase III studies, Reliance II (Study 302) and Relight (Study 304), are ongoing. These studies are randomized, double-blind, and placebo-controlled, with the same key study design parameters. The Reliance II study is expected to have an interim analysis by the end of 2024, which will be pivotal in determining the study's direction[1][3][4].

Efficacy and Safety

The efficacy and safety of REL-1017 have been consistently positive across various trials. A long-term, open-label Phase 3 trial (Study REL-1017-310) showed that REL-1017 was well-tolerated with long-term dosing, exhibiting low rates of adverse events and discontinuations due to adverse events. The study also highlighted the rapid and sustained therapeutic effects of the drug, which remain consistent across all trials conducted to date[4].

Market Projection

Market Growth Potential

The major depressive disorder market is expected to register immense growth by 2034, driven in part by a robust pipeline of new treatments. REL-1017, with its novel mechanism and promising clinical results, is positioned to be a significant player in this growing market[2].

Competitive Landscape

REL-1017's mechanism is similar to that of other approved products like Johnson & Johnson's Spravato, but its unique targeting of hyperactive NMDA channels offers a differentiated approach. This differentiation could provide a competitive edge in the market, especially if the ongoing Phase III trials yield positive results[5].

Financial Outlook

Relmada Therapeutics has reported a decrease in cash and investments and a net loss for the third quarter of 2024, primarily due to increased spending on research and development. However, the company maintains strong liquidity with a current ratio of 6.89 and holds more cash than debt on its balance sheet. The outcome of the ongoing trials, particularly the interim analysis of the Reliance II study, will be crucial in shaping the company's financial future and market projection for REL-1017[3][5].

Regulatory Status

REL-1017 has been granted Fast Track Designation by the U.S. FDA as an adjunctive treatment for MDD. This designation underscores the potential of REL-1017 to address an unmet medical need and could expedite its regulatory approval process[2].

Future Directions

  • Interim Analysis: The upcoming interim analysis for the Reliance II Phase 3 study by the end of 2024 will be critical in determining the future course of the study and the overall development trajectory of REL-1017[3].
  • Additional Studies: Relmada Therapeutics is also planning to initiate a Phase 2a study for its psilocybin-based candidate, REL-P11, in 2025. This diversification in the pipeline could further strengthen the company's position in the CNS treatment market[3].

Challenges and Considerations

Despite the promising data, there are challenges ahead. Recent updates have led to some analyst downgrades, reflecting uncertainty in the market's outlook. However, Relmada's strong liquidity and ongoing clinical programs suggest that the company is well-positioned to navigate these challenges[5].

Key Takeaways

  • Clinical Success: REL-1017 has shown rapid, strong, and lasting antidepressant effects in clinical trials.
  • Ongoing Trials: Phase III trials, including Reliance II and Relight, are critical for the drug's approval and market entry.
  • Regulatory Support: Fast Track Designation by the U.S. FDA highlights the drug's potential.
  • Financial Position: Relmada Therapeutics maintains strong liquidity despite current financial challenges.
  • Market Potential: The MDD market is expected to grow significantly, with REL-1017 poised to be a key player.

FAQs

Q: What is the mechanism of action of REL-1017? A: REL-1017 works by selectively blocking overactive NMDA channels while preserving normal glutamatergic neurotransmission.

Q: What are the current clinical trials for REL-1017? A: REL-1017 is currently in Phase III trials, including Reliance II (Study 302) and Relight (Study 304), both of which are randomized, double-blind, and placebo-controlled.

Q: What are the efficacy and safety results of REL-1017 from clinical trials? A: REL-1017 has shown rapid and sustained therapeutic effects with a favorable safety, tolerability, and pharmacokinetic profile in clinical trials.

Q: What is the regulatory status of REL-1017? A: REL-1017 has been granted Fast Track Designation by the U.S. FDA for the adjunctive treatment of MDD.

Q: What are the future directions for Relmada Therapeutics beyond REL-1017? A: Relmada Therapeutics is planning to initiate a Phase 2a study for its psilocybin-based candidate, REL-P11, in 2025.

Sources

  1. Relmada Therapeutics Announced Publication of Results from the Phase 3 Reliance I Study of REL-1017 in The Journal of Clinical Psychiatry. Relmada Therapeutics.
  2. Major Depressive Disorder Market to Register Immense Growth by 2034, Owing to a Robust Pipeline - DelveInsight. PR Newswire.
  3. Earnings call: Relmada Therapeutics reports Q3 financials, focuses on REL-1017. Investing.com.
  4. Relmada Therapeutics Announces Efficacy and Safety Results from the Phase 3 Long-Term Study of REL-1017 in Major Depressive Disorder. BioSpace.
  5. Relmada Therapeutics downgraded to Market Perform - Investing.com. Investing.com.

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