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RELMADA THERAPEUTICS, INC. (RLMD)

Relmada Therapeutics, Inc. operates as a clinical-stage biotechnology company in the United States. The company focuses on the development of NDV-01, a controlled-release intravesical formulation of gemcitabine and docetaxel, which is in Phase 2 clinical trial for patients with aggressive forms of non-muscle invasive bladder cancer; and Sepranolone, a neurosteroid epimer of allopregnanolone, which is Phase 2b-ready for the potential treatment of prader-willi syndrome, tourette syndrome, excessive tremor, and other diseases related to excessive GABAergic activity. The company has an agreement with Asarina Pharma AB and Trigone. Relmada Therapeutics, Inc. was founded in 2004 and is headquartered in Coral Gables, Florida.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Relmada Therapeutics, Inc. logo

Relmada Therapeutics, Inc.

NASDAQ:RLMDHealthcare
+4.07%$3.58
AH$3.50-2.23%vs close
Mkt Cap$381.88M
Float86.94M
O/S106.67M
Vol
$ Vol
RVOL
Inst Own94.2%
SI14.0%
Earnings
Dilution
Phase Distribution
11 lead-sponsored trials·1 active·6 completed
Phase 12
Phase 22
Phase 36
Not applicable1
Status Overview
Not yet recruiting1
Recruiting1
Completed6
Stopped2
Expanded access1

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 3
    Completed

    A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)

    REL-1017, Placebo

    Major Depressive Disorder

    Enrollment
    227
    Start
    Jan 2021
    Primary Completion
    Nov 2022
    Completion
    Nov 2022
    NCT04688164
  • Phase 3
    Completed

    Safety of REL-1017 for Major Depressive Disorder

    REL-1017

    Major Depressive Disorder

    Enrollment
    627
    Start
    Apr 2021
    Primary Completion
    Jul 2023
    Completion
    Jul 2023
    NCT04855760
  • Phase 3
    Completed

    A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)

    REL-1017, Placebo

    Major Depressive Disorder

    Enrollment
    232
    Start
    Jun 2021
    Primary Completion
    Sep 2022
    Completion
    Sep 2022
    NCT05081167
  • Phase 3
    Withdrawn

    A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT

    NDV-01 (sustained-release gemcitabine-docetaxel)

    Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer +2

    Enrollment
    0
    Start
    May 2026est.
    Primary Completion
    Sep 2029est.
    Completion
    Nov 2029est.
    NCT07313891
  • Phase 3
    Withdrawn

    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

    NDV-01 (sustained-release gemcitabine-docetaxel)

    Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) +3

    Enrollment
    0
    Start
    Jun 2026est.
    Primary Completion
    Jun 2027est.
    Completion
    Jun 2028est.
    NCT07342517
  • Phase 3
    Not yet recruiting

    A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer

    NDV-01 (sustained-release gemcitabine-docetaxel)

    Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) +3

    Enrollment
    393
    Start
    Feb 2027est.
    Primary Completion
    Dec 2029est.
    Completion
    Dec 2032est.
    NCT07464145
  • Phase 2
    Completed

    Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD

    REL-1017, Placebo

    Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant

    Enrollment
    62
    Start
    May 2018
    Primary Completion
    Jul 2019
    Completion
    Sep 2019
    NCT03051256
  • Phase 2
    Recruiting

    A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC

    NDV01 intravesical controlled release formulation of gemcitabine and docetaxel

    Non Muscle Invasive Bladder Cancer

    Enrollment
    70
    Start
    Aug 2024
    Primary Completion
    Nov 2027est.
    Completion
    Dec 2027est.
    NCT06663137
  • Phase 1
    Completed

    Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of REL-1017 (d-Methadone)

    REL-1017, Placebo

    Neuropathic Pain

    Enrollment
    42
    Start
    Dec 2014
    Primary Completion
    Jun 2015
    Completion
    Jun 2015
    NCT03637361
  • Phase 1
    Completed

    Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REL-1017 (d-Methadone)

    REL-1017, Placebo

    Neuropathic Pain

    Enrollment
    24
    Start
    Aug 2015
    Primary Completion
    Nov 2015
    Completion
    Nov 2015
    NCT03638869
  • Expanded access
    No longer available

    Individual Patient Esmethadone (REL-1017) Expanded Access Program

    REL-1017

    Major Depressive Disorder, Depression

    Enrollment
    -
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT06009003