Opioid receptors antagonists(Opioid receptors antagonists), κ opioid receptor agonists(Kappa opioid receptor agonists), μ opioid receptor antagonists(Mu opioid receptor antagonists)

Therapeutic Areas

Other DiseasesRespiratory DiseasesSkin and Musculoskeletal Diseases

Active Indication

AlcoholismOpiate OverdoseRespiratory Insufficiency+ [2]

Inactive Indication

Gambling

Originator Organization

Baxter International, Inc.

Active Organization

Tharimmune, Inc.

Titan Pharmaceuticals, Inc.

H. Lundbeck A/S

+ [6]

Inactive Organization

Somaxon Pharmaceuticals, Inc.Hikma Pharmaceuticals USA, Inc.

Opiant Pharmaceuticals, Inc.

Drug Highest PhaseApproved

First Approval Date

US (17 Apr 1995),

Opiate Overdose

RegulationPriority Review (US), Fast Track (US)

Structure

Molecular FormulaC21H26ClNO3

InChIKeyGYWMRGWFQPSQLK-OPHZJPRHSA-N

CAS Registry58895-64-0

Clinical Trials associated with Nalmefene Hydrochloride

NCT06408714 / Not yet recruitingPhase 3IIT

Comparison of Nalmefene Hydrochloride Injection and Naloxone Hydrochloride Injection for the Treatment of Recurrent Respiratory Depression After Suspected Acute Opioid Overdose in the Emergency Department

The goal of this clinical trial is to compare naloxone to nalmefene for the treatment of opioid overdose in adults. The main questions it aims to answer are:
Does nalmefene lower the number of doses of medicine participants need to treat opioid overdose?
When participants are given nalmefene instead of naloxone, do they have fewer complications of opioid overdose such as being admitted to the hospital or having a breathing tube inserted?
Researchers will compare nalmefene to naloxone for the treatment of opioid overdose. Nalmefene and naloxone are both approved medicines to treat opioid overdose.
Participants who are brought to the emergency department after an opioid overdose will be given a dose of either nalmefene or naloxone if their breathing slows down again after an opioid overdose. Participants will:
Stay in the emergency department for 8 hours after receiving a dose of nalmefene or naloxone.
Receive a phone call 7 days after their emergency department to check on how they are doing.
Background information:
Naloxone (also known as Narcan) and nalmefene are opioid blocking medicines. When someone overdoses on an opioid, such as heroin or fentanyl, their breathing slows down or stops and they can die. By giving naloxone or nalmefene, the effect of the opioid can be blocked and the person can start breathing again. Naloxone is the most commonly used medicine to reverse an opioid overdose. The effect of naloxone lasts about an hour, and patients may need more than one dose of naloxone to keep them breathing. Sometimes patients overdose, get a dose of naloxone and wake up, and then some time later their breathing slows down again and they need another dose of naloxone. This can happen because the effect of the opioid they took lasts longer than the effect of the naloxone.
The effect of nalmefene lasts longer than naloxone, about four hours. If a person gets nalmefene, their opioid may wear off before the nalmefene wears off and they might not need any more doses of a reversal medicine. Both naloxone and nalmefene are approved medicines for treating opioid overdose.
Often, when a person overdoses on an opioid, someone gives them naloxone right away and then they are brought to the emergency department. In the emergency department, they are watched for several hours to make sure they don't stop breathing again when their naloxone wears off. If they do stop breathing again, they are given another dose of naloxone. In this study, participants will be given either nalmefene or naloxone if their breathing slows down while they are in the emergency department.

Start Date01 Jul 2024

Sponsor / Collaborator

The University of New Mexico

ChiCTR2400083472 / RecruitingPhase 1IIT

Observation on the effect of nalmefene pre-injection on the prevention of hypoxemia during painless gastroscopy in high-risk patients with difficult airway

Start Date10 May 2024

Sponsor / Collaborator-

NCT06198686 / Active, not recruitingPhase 1

An Evaluation of The Absolute Bioavailability of TH104

This is a single-dose, single-center, open-label, randomized, 2-way crossover study (2 treatments, 2 periods and 2 sequences) of a buccal formulation of Nalmefene 16 mg and a 1 mg intravenous dose of nalmefene injection, with a least 7 days washout period between doses.

Start Date26 Jan 2024

Sponsor / Collaborator

Tharimmune, Inc.

100 Clinical Results associated with Nalmefene Hydrochloride

100 Translational Medicine associated with Nalmefene Hydrochloride

100 Patents (Medical) associated with Nalmefene Hydrochloride

404

Literatures (Medical) associated with Nalmefene Hydrochloride

01 May 2024·Current neuropharmacology

Pharmacological Treatment of Alcohol use Disorder in Patients with Psychotic Disorders: A Systematic Review

Review

Author: Nielsen, Anette Søgaard ; Nielsen, Dorthe Grüner ; Højlund, Mikkel ; Anhøj, Simon ; Mellentin, Angelina Isabella ; Rosenstand, Niels Jørgen ; Skøt, Lotte

Background::

Patients with psychotic disorders (PD) often have comorbid alcohol use disorder (AUD), which is typically treated pharmacologically. Up till now, no systematic review has examined the effectiveness and safety of AUD treatment in PD patients.

Objectives::

This study aimed to systematically review the literature on (1) the effects of pharmacological treatments for AUD on drinking outcomes, (2) the side effects of the drugs, and (3) the effects of polypharmacy in patients with comorbid AUD and PD.

Methods::

Bibliographic searches were conducted in MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and PsycINFO. At least two reviewers extracted the data, assessed the risk of bias, and performed the qualitative synthesis of the collected evidence.

Results::

Twelve eligible studies were identified, half being randomized controlled trials (RCTs). Three studies examined disulfiram, nine naltrexone, two acamprosate, and one nalmefene by comparing the effects of treatment to placebo, baseline, or pharmacological agents. Disulfiram and naltrexone were shown to reduce alcohol intake. Regarding acamprosate, the findings were mixed. Nalmefene decreased alcohol intake. All pharmacological agents appeared safe to use as AUD monotherapy, but cardiac events were reported when combining naltrexone and disulfiram. Nine studies had a high risk of bias, and three had some other concerns.

Conclusion::

The studies provide tentative support for the use of naltrexone and disulfiram in this population, although combinations of pharmacological AUD treatments and other polypharmacy remain unexplored. The studies had high adherence rates that are hardly replicable in real-world settings. Thus, the findings should be confirmed in larger high quality efficacy and effectiveness RCTs with longer follow-ups.

01 Feb 2024·The Australian and New Zealand journal of psychiatry

Economic evaluations of alcohol pharmacotherapy: Systematic review of economic evaluations of pharmacotherapy for the treatment of alcohol use disorder

Review

Author: Lubman, Dan ; Haber, Paul S ; Higginbotham, Benjamin ; Chatterton, Mary Lou ; Louie, Eva ; Arunogiri, Shalini ; Morley, Kirsten C ; Perez, Joahna Kevin

Objective::

Alcohol use disorders confer a significant burden of disease and economic cost worldwide. However, the utilisation of pharmacotherapies to manage alcohol use disorder is poor. We aimed to conduct a systematic review of economic evaluation studies of alcohol use disorder pharmacotherapies.

Methods::

A search was conducted in Embase, Medline, CINAHL, PsychINFO and EconLit (August 2019, updated September 2022). Full economic evaluations using pharmacotherapy to treat alcohol use disorders were included. Included studies were stratified by medication and summarised descriptively. The Consensus on Health Economic Criteria list was used to assess the methodological quality.

Results::

A total of 1139 studies were retrieved, of which 15 met the inclusion criteria. All studies were conducted in high-income countries. Four studies analysed nalmefene, four studies assessed acamprosate, three for naltrexone and four for stand-alone and/or combinations of naltrexone and acamprosate. There were 21 interventions synthesised from 15 studies as some studies evaluated multiple interventions and comparators. More than half of the included studies (73%) reported pharmacotherapy as dominant (less costly and more effective than comparators). From healthcare payer perspectives, five studies found that pharmacotherapy added to psychosocial support was dominant or cost-effective, accruing additional benefits at a higher cost but under accepted willingness to pay thresholds. Three analyses from a societal perspective found pharmacotherapy added to psychosocial support was a dominant or cost-effective strategy. Quality scores ranged from 63% to 95%.

Conclusion::

Pharmacotherapy added to psychosocial support was cost-effective from both healthcare and societal perspectives, emphasising an increased role for pharmacotherapy to reduce the burden of alcohol use disorders.

01 Feb 2024·Journal of clinical anesthesia

Prophylatic use of IV nalmefene to prevent epidural opioid-induced pruritus: A multicenter, randomized clinical trial

Article

Author: Fang, Fang ; Jiang, Ming ; Li, Ailun ; Cang, Jing ; Li, Guiting ; Chen, Junjun ; Li, Juchen ; Huang, Jiapeng ; Yan, Huan ; Li, Weishan ; Luo, Jingwen

STUDY OBJECTIVE:

The incidence of pruritus from neuraxial opioids is about 60%. Pruritus causes discomfort and decreases the quality of recovery. This randomized double-blinded clinical trial was aimed to evaluate the prophylactic effects of a single dose IV nalmefene on the incidence and severity of epidural opioid-induced pruritus within 24 h after surgeries.

DESIGN:

A two-center, randomized, double blinded, controlled clinical trial.

SETTING:

The study was conducted from March 2022 to February 2023 at two tertiary care hospitals in China.

PATIENTS:

Patients aged between 18 and 80 years-old who underwent elective surgeries and received epidural analgesia intra- and post-operatively were screened for study enrollment. A total of 306 patients were enrolled, 302 patients underwent randomization and 296 patients were included in the final analysis.

INTERVENTIONS:

The nalmefene group was prophylactically given 0.5 μg/kg nalmefene intravenously while the control group was given the same volume of saline.

MEASUREMENTS:

The primary endpoint was the incidence of pruritus within 24 h after surgeries. The secondary endpoints included time of the first patient-reported pruritus, severity of pruritus after surgeries, severity of acute pain scores after surgeries and other anesthesia/analgesia related side effects.

MAIN RESULTS:

Pruritus occurred in 51 of the 147 (34.69%) patients in the control group and 35 of the 149 (23.49%) patients in the nalmefene group (odds ratio, 0.58; 95% CI, 0.35 to 0.96; P = 0.034) within 24 h postoperatively. Nalmefene group demonstrated delayed onset of pruritus, reduced severity of pruritus and decreased vomiting within 24 h after surgery. There were no significant differences in postoperative analgesia and the incidence of other anesthesia/analgesia associated side effects.

CONCLUSIONS:

A single dose of 0.5 μg/kg nalmefene intravenously significantly reduced the incidence and severity of epidural-opioid induced pruritus within 24 h after surgery without affecting the efficacy of epidural analgesia.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry (www.chictr.org.cn) and the registration number is ChiCTR2100050463. Registered on August 27th, 2021.

News (Medical) associated with Nalmefene Hydrochloride

17 Jun 2024

·www.biospace.com

Tharimmune Announces Positive Type C Meeting with FDA for Phase 2 Program for TH104, its Lead Candidate for Moderate-to-Severe Pruritus in Primary Biliary Cholangitis

FDA Provides Positive Feedback to Company Regarding TH104 Phase 2 Program Company Incorporating FDA Feedback into Phase 2 Protocol Company Believes it is On-track to Initiate Phase 2 Trial BRIDGEWATER, NJ / ACCESSWIRE / June 17, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology, reports positive Type C meeting feedback from the U.S. Food and Drug Administration (FDA) for its Phase 2 clinical trial with TH104, a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene for moderate-to-severe pruritus or "uncontrolled itching" in primary biliary cholangitis (PBC), a rare form of liver disease with no known cure. "We are pleased with the outcome of our recently received feedback from the FDA and are excited to progress the development program for our novel buccal delivery asset, TH104 for pruritus in PBC patients," said Randy Milby, Chief Executive Officer of Tharimmune. TH104, the Company's lead clinical product candidate is designed to avoid the liver's first-pass metabolism of oral formulations and, as such, may be a preferred candidate for liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action that affects both the mu (μ-) and kappa opioid receptors. These extensively studied receptors, when stimulated and/or inhibited by the body's endogenous ligands, have been implicated in human itch circuitry for certain conditions, specifically cholestatic liver conditions. Tharimmune's recently received Type C meeting feedback from the FDA confirmed the Company's plan to pursue a 505(b)(2) approval pathway for TH104, which permits inclusion of data from external studies when the active ingredient is already approved in the United States. The FDA also agreed that the nonclinical studies submitted to the FDA in advance of the meeting appear sufficient to support the proposed Phase 2 clinical trial. In addition, the FDA provided feedback on study design and certain recommendations regarding PBC patient inclusion, the primary endpoint to assess pruritus in these patients, and considerations for monitoring for adverse events in this patient population. Based on this interaction, the Company believes it has a path forward to a Phase 2 trial with TH104 in moderate-to-severe chronic pruritus in PBC patients and is currently incorporating feedback from the FDA into its clinical protocol and anticipates initiating the trial in the latter part of 2024. About TH104 TH104 is embedded with nalmefene onto a proprietary transmucosal buccal film that easily adheres to the inside of the mouth. This dosage form endows TH104 with key features making it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the µ-opioid and kappa opioid receptors. These opioid receptors when stimulated and/or inhibited by the body's natural ligands have been known to be involved in the body's itch circuitry. About Tharimmune Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company's lead clinical-stage asset, TH104, has been observed to suppress chronic, debilitating pruritus or "uncontrollable itching" in PBC, a rare and orphan liver disease with no known cure. The Company's early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company's antibody discovery technology platform against these and other specified targets. For more information please visit: . Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release. Contacts: Tharimmune, Inc. ir@tharimmune.com LHA Investor Relations Tirth T. Patel tpatel@lhai.com 212-201-6614 SOURCE: Tharimmune, Inc. View the original press release on accesswire.com

Phase 2License out/in

10 Jun 2024

·www.biospace.com

Tharimmune Announces Positive Results of Phase 1 Trial in Healthy Subjects with TH104, its Lead Candidate for Moderate-to-Severe Pruritus in Primary Biliary Cholangitis

Pharmacokinetic pro oral transmucosal delivery of TH104 was comparable to intravenous delivery of reference drug Positive safety/tolerability achieved with TH104 reporting a mild side-effect pro > Planning for Phase 2 trial for moderate-to-severe chronic pruritus in primary biliary cholangitis (PBC) is ongoing and on track to initiate in 2024 BRIDGEWATER, NJ / ACCESSWIRE / June 10, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology, reports positive results from its Phase 1 clinical trial with TH104, a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene that easily adheres inside of the mouth on the cheek and biodegrades within minutes. Results in healthy subjects demonstrated consistent pharmacokinetic (PK) profiles across buccal and intravenous routes of administration with a comparable safety and tolerability pro routes of administration. "We are pleased with the results of our Phase 1 trial of TH104, and our expectations for a predictable kinetic pro demonstrating excellent safety and tolerability by transmucosal administration have been met. With these results, we look forward to advancing TH104 to a Phase 2 trial this year," said Randy Milby, Chief Executive Officer of Tharimmune. "We would like to thank the volunteers for participating in this trial where the data generated are a critical step forward to continue our momentum and remain on track to advance the development of this important program." TH104, the Company's lead clinical asset, is designed to avoid the liver's first-pass metabolism of oral formulations and, as such, may be a preferred product candidate for liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action that affects both the mu (μ-) and kappa opioid receptors. These extensively studied receptors, when stimulated and/or inhibited by the body's endogenous ligands, have been implicated in human itch circuitry for certain conditions, specifically cholestatic liver conditions. This Phase 1 trial is a single-dose, single-center, open-label, randomized 2-way crossover study comparing 16mg of TH104 with 1mg intravenous nalmefene administered under fasting conditions, with a 7-day washout period between doses. Twenty healthy subjects were enrolled to complete both doses of the crossover design. All 20 subjects completed TH104 buccal dosing, while 19 of 20 subjects also completed the intravenous dosing. The primary objective was to evaluate the absolute bioavailability of TH104, as well as to assess safety and tolerability. Findings from the study indicate that the primary endpoint of the absolute bioavailability (F) of TH104, or fraction (or percentage) of the administered dose absorbed into the systemic circulation compared to an equivalent intravenous dose of nalmefene, was 0.459 (45.9%). The median time to maximum concentration (Cmax) of TH104 was 2.0 hours, with rising concentrations beginning within minutes of dosing. The mean half-life (T1/2) as measured in the blood of subjects was 14 hours after a single buccal administration of TH104, compared to 9 hours for the 1mg intravenous dose of nalmefene. These data are consistent and within range of published findings of population PK data of nine Phase 1 studies of 243 subjects with extensive blood sampling.1. Furthermore, in the same analysis, receptor occupancy of oral dosing of nalmefene using a robust PK model for nalmefene was developed where a single 20mg dose showed μ-opioid receptor occupancy was simulated to be within or above 60-90% for up to 22-24 hours. The Company believes PK results from this Phase 1 trial show proportional kinetics consistent with published findings of oral and intravenous formulations of nalmefene including F, Cmax, T1/2 and potential receptor occupancy time, suggest TH104 could be developed for once-daily dosing in a target population of moderate-to-severe chronic pruritus in PBC patients. The Phase 1 trial also demonstrated that a 16mg dose of TH104 had a comparable safety and tolerability pro the FDA-approved 1mg dose of nalmefene intravenous formulation. Treatment emergent adverse events (TEAEs) were reported in 8 subjects (40.0%) in the TH104 group and 7 subjects (36.8%) in the intravenous group. All reported TEAEs were considered mild in severity. The most frequently reported TEAE for both TH104 and intravenous treatments was dizziness (4 subjects in the TH104 group; 7 subjects in the intravenous group). TEAEs reported in at least 2 subjects in any treatment group were nausea (3 subjects in each group) and somnolence (3 subjects in each group). There were no serious adverse events reported during this study. No subjects discontinued the study due to adverse events. No subjects exhibited abnormal results for the visual examinations of the buccal mucosa pre- or post-dosing with TH104 buccal film. The Company continues to have discussions with the FDA regarding its Phase 2 program and intends to initiate a clinical trial with TH104 in moderate-to-severe chronic pruritus in PBC patients in 2024. About TH104 TH104 is embedded with nalmefene onto a proprietary transmucosal buccal film which easily adheres to the inside of the mouth. This endows TH104 with key features making it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the µ-opioid and kappa opioid receptors. These opioid receptors when stimulated and/or inhibited by the body's natural ligands have been known to be involved in the body's itch circuitry. About Tharimmune Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company's lead clinical-stage asset, TH104 is known to suppress chronic, debilitating pruritus or "uncontrollable itching" in PBC, a rare and orphan liver disease with no known cure. The Company's early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company's antibody discovery technology platform against these and other specified targets. For more information please visit: . Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release. References Kyhl, L. B., Shen, L., Faerch, K. U., Soegaard, B., Larsen, F., & Areberg, J. (2016). Population pharmacokinetics of nalmefene in healthy subjects in relation to μ-opioid receptor occupancy. British Journal of Clinical Pharmacology, 81(2), 290-300. Contacts: Tharimmune, Inc. ir@tharimmune.com LHA Investor Relations Tirth T. Patel tpatel@lhai.com 212-201-6614 SOURCE: Tharimmune, Inc. View the original press release on accesswire.com

Phase 1Clinical ResultLicense out/inPhase 2

29 May 2024

·www.biospace.com

Tharimmune to Present at 2024 BIO International Convention

BRIDGEWATER, NJ / ACCESSWIRE / May 29, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, announces that management will be presenting at the 2024 BIO International Convention being held June 3-6, 2024 in San Diego. The Company will be presenting at the convention and will hold 1x1 meetings with investors and industry leaders. Event: 2024 BIO International Convention Date: Monday, June 3, 2024 Time: 1:45 p.m. Pacific Time Location: Company Presentation Theater 3 To schedule a meeting with the Company's management at the convention, please submit a meeting request through the BIO One-on-One Partnering™ system or contact Tirth Patel from LHA Investor Relations at tpatel@lhai.com. About Tharimmune Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company's lead clinical-stage asset, TH104 is known to suppress chronic, debilitating pruritus or "uncontrollable itching" in PBC, a rare and orphan liver disease with no known cure. The Company's early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company's antibody discovery technology platform against these and other specified targets. For more information please visit: . Contacts: Tharimmune, Inc. ir@tharimmune.com LHA Investor Relations Tirth T. Patel tpatel@lhai.com 212-201-6614 SOURCE: Tharimmune, Inc. View the original press release on accesswire.com

License out/inImmunotherapy

100 Deals associated with Nalmefene Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02104	Nalmefene Hydrochloride	N07BB05	DB06230

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Alcoholism	EU	H. Lundbeck A/S	24 Feb 2013
Alcoholism	IS	H. Lundbeck A/S	24 Feb 2013
Alcoholism	LI	H. Lundbeck A/S	24 Feb 2013
Alcoholism	NO	H. Lundbeck A/S	24 Feb 2013
Opiate Overdose	US	Hikma Pharmaceuticals USA, Inc.	17 Apr 1995

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Insufficiency	Phase 3	US	The University of New Mexico	01 Jul 2024
Gambling	Phase 3	-	Somaxon Pharmaceuticals, Inc.	01 Aug 2005
Pruritus	Phase 2	-	Avior Bio, Inc.Startup	24 Mar 2022
Opioid-Related Disorders	Phase 1	US	Opiant Pharmaceuticals, Inc.	01 Sep 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Biospace Manual	Phase 1	Chronic liver disease	12	TH104	qgyteiofau(pdywnysugt) = lmmrtcizwf hxsspbqpyf (dzoutjmizz ) View more	Positive	11 Dec 2023
Biospace Manual	Phase 1	Chronic liver disease	12	TH104 (Child-Pugh A)	qgyteiofau(pdywnysugt) = xqmpzmyuad hxsspbqpyf (dzoutjmizz ) View more	Positive	11 Dec 2023
Biospace Manual	Phase 1	Cholestatic pruritus	-	TH104	mgikmtvwdo(dolgzzsrfk) = The Cmax and AUC0-∞ of TH104 was observed to be higher than the tablet product because of a possible reduced presystemic metabolism in the lower GI and liver, which is potentially advantageous for patients with an impaired liver. The half-life and Tmax was observed to be similar for both products. pxzmnhbzlu (wwoeujqxzw ) View more	Positive	27 Nov 2023
NCT03278886 (CTgov)	Phase 1/2	Pain \| Alcohol-Related Disorders \| Inflammation ... View more	11	Low dose naltrexone (Low Dose Naltrexone)	buwuqdmsnk(ahjodlxynw) = mseqfvoszg hmvzmsttwc (khniumwaqm, bntrlgbtem - operrntjjm) View more	-	03 Aug 2020
NCT03278886 (CTgov)	Phase 1/2		11	Nalmefene (Nalmefene)	buwuqdmsnk(ahjodlxynw) = klbrcqhyhs hmvzmsttwc (khniumwaqm, vnoabemfxq - lbyhpgbwyr) View more	-	03 Aug 2020
NCT02382276 (CTgov)	Phase 3	Alcoholism	405	Nalmefene (Nalmefene 20 mg in the lead-in Study)	lceoyxqnxp(pbxxoeppcu) = ilmcrezacg znrsektpwm (wnsuccwjcz, gorpueztfs - amfgynjdyx) View more	-	20 Jul 2020
NCT02382276 (CTgov)	Phase 3	Alcoholism	405	Nalmefene (Nalmefene 10 mg in the lead-in Study)	lceoyxqnxp(pbxxoeppcu) = aubmjmefbs znrsektpwm (wnsuccwjcz, dklymsrfvq - acqarcntjo) View more	-	20 Jul 2020
NCT02364947 (CTgov)	Phase 3	Alcoholism	678	Nalmefene hydrochloride (Nalmefene Hydrochloride 20 mg)	plkualghfv(iddfrapfix) = qehcckwbfs uspnhebxzf (xlhprjodex, ielqkzvamx - qspqlshjcq) View more	-	30 Sep 2019
NCT02364947 (CTgov)	Phase 3	Alcoholism	678	Nalmefene hydrochloride (Nalmefene Hydrochloride 10 mg)	plkualghfv(iddfrapfix) = hzpvtrrrga uspnhebxzf (xlhprjodex, ozbxlfxhyl - hcjsycippo) View more	-	30 Sep 2019
NCT02679469 (CTgov)	Phase 1	Alcoholism	7	nalmefene hydrochloride 10 mg	nkiulqfxxv(mgnqbvzzzs) = esbyvxvogh zghgkrydry (alstuyqvbj, dmkhlfjypj - moimjsjzvw) View more	-	18 Apr 2017
NCT00811941 (CTgov)	Phase 3	Alcoholism	665	Placebo	vqgjrdszpc(osltiblhsv) = gqhprmszyl jftmjqjjkt (grmsmnllvh, exwvvicunj - ogmlbejnok) View more	-	07 Aug 2013
NCT00812461 (CTgov)	Phase 3	Alcoholism	678	Placebo	enhocrlwcj(hjsckfrxij) = vflzafeqgz vbrehkvrmv (qjpneztxfq, yzffqyxzsr - jhcvmqfzoj) View more	-	09 Jul 2013
NCT00811720 (CTgov)	Phase 3	Alcoholism	598	Placebo	djnimyhpzl(wdqxskfzvd) = wtfrwduiri axevbfezyj (djhcwccyan, mmdqjwhblr - vnkufzddry) View more	-	09 Jul 2013
ESENSE 1 (NCT00811720) and ESENSE 2 (NCT00812461) (Pubmed \| Alcohol Alcohol)	Not Applicable	-	667	Nalmefene 18 mg	srnzotqpwb(mpaoshnxzd) = founzmovjj sjwivwfije (wgzhjhxnvu )	Positive	01 Jan 2013

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