Delving into the Latest Updates on Ketamine Hydrochloride with Synapse

Overview

Basic Info

SummaryKetamine is a small molecule drug that acts as a modulator at the N-methyl-D-aspartate (NMDA) receptor. It is marketed under the trade name KETALAR and is primarily used as an anesthetic drug. Ketamine was first approved for medical use in the United States in 1970 by Endo International. This drug is available as a slightly acidic, sterile solution for intravenous or intramuscular injection. Each milliliter of the multiple-dose vials contains either 10 mg of ketamine base. Ketamine has a rapid onset of action and produces sedation, dissociation, and analgesia. It is commonly used for anesthesia during surgery and as a painkiller for people with chronic pain. Ketamine may have some potential as an antidepressant, but more research is needed to determine its efficacy and safety for this indication. The use of ketamine as an anesthetic or painkiller may cause some side effects, including hallucinations, nausea, and vomiting.

Drug Type

Small molecule drug

Synonyms

(+-)-Ketamine, (±)-ketamine, 2-(2-Chloro-phenyl)-2-methylamino-cyclohexanone

+ [37]

Target

NMDA receptor

Action

modulators

Mechanism

NMDA receptor modulators(Glutamate [NMDA] receptor modulators)

Therapeutic Areas

Nervous System DiseasesOther DiseasesCongenital Disorders+ [5]

Active Indication

AnesthesiaPainBipolar and Related Disorders+ [18]

Inactive Indication

Amyotrophic Lateral SclerosisAutism Spectrum DisorderBunion+ [5]

Originator Organization

Endo International Plc

Active Organization

NeuroRx, Inc.

Bexson Biomedical, Inc.Startup

Awakn Life Sciences, Inc.

+ [17]

Inactive Organization

Roivant Sciences, Inc.

Douglas Pharmaceuticals Ltd.Novartis Pharma AG

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (19 Feb 1970),

Anesthesia

RegulationFast Track (United States), Orphan Drug (United States), Innovative Licensing and Access Pathway (United Kingdom)

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Structure/Sequence

Molecular FormulaC13H16ClNO

InChIKeyYQEZLKZALYSWHR-UHFFFAOYSA-N

CAS Registry6740-88-1

View All Structures (2)

PURPOSE OF REVIEWComplex Regional Pain Syndrome (CRPS) is a neuropathic pain disorder characterized by pain disproportionate to the inciting event that is constant for an extended duration. Numerous treatment options for this condition have been explored with unsatisfactory results in many cases. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist typically used as an anesthetic and analgesic, presents a promising potential treatment for CRPS in patients who fail to respond to traditional therapies.RECENT FINDINGSNumerous studies report significant improvement in the degree of pain, mobility of extremities, and other parameters after ketamine infusion in patients with CRPS. Although adverse effects were not reported often, some subjects experienced nausea, vomiting, headache or psychotropic or psychomimetic symptoms which could be mitigated with cessation of the drug. Although more research is needed to determine optimal dosing and duration, ketamine seems to be a safe and effective treatment for refractory cases of CRPS.CONCLUSIONThe present investigation summarizes existing knowledge and research surrounding ketamine infusions for CRPS to provide a well-rounded depiction of advantages and disadvantages for physicians who may be considering it for patients with this challenging and complex condition.

01 Dec 2025·Current Pain and Headache Reports

Pain and Perception: Exploring Psychedelics as Novel Therapeutic Agents in Chronic Pain Management

Review

Author: Maloney, Jillian ; Gomez, Diego ; Whitney, Madeline ; Strand, Natalie H ; Emami, Eric ; Leathem, James ; Viswanath, Omar ; Attanti, Sumedha ; Misra, Lopa ; Johnson, Brooks ; Dunn, Tyler

PURPOSE OF REVIEWChronic pain affects approximately 1.5 billion people worldwide, representing the leading cause of disability and a significant financial burden on healthcare systems. Conventional treatments, such as opioids and non-steroidal anti-inflammatory drugs, are frequently linked to adverse effects, including dependency and gastrointestinal issues, and often offer limited long-term relief. This review explores the potential of psychedelics, including psilocybin, LSD, and ketamine, as alternative therapeutic agents in chronic pain management.RECENT FINDINGSThese substances modulate pain perception through actions on serotonergic and glutamatergic systems and may promote neuroplasticity, offering novel pathways for pain relief. Specifically, the review details the pharmacologic actions of psychedelics, their effects on chronic pain syndromes such as cancer pain, migraines, and neuropathic pain, and their clinical implications. The safety profiles, patient responses, and analgesic properties of these compounds are examined, highlighting the need for further research to validate their efficacy and optimize their therapeutic use in pain management.

01 Jun 2025·Toxicology Reports

Rising incidence of recreational ketamine use: Clinical cases and management in emergency settings

Article

Author: Marongiu, Sabrina ; Franssen, Eric J F ; van Eijk, Maarten ; Croes, Esther A ; Gresnigt, Femke M J

The recreational use of ketamine has risen significantly in the Netherlands, particularly among young adults in nightlife settings. This trend has been accompanied by an increase in first aid incidents involving ketamine, often in combination with other substances such as alcohol or MDMA, leading to heightened toxicity. Acute intoxication with ketamine manifests through symptoms like agitation, hallucinations, nausea, tachycardia, and hypertension, while frequent use is associated with long-term complications, including ketamine-induced uropathy. Although ketamine is not currently included in standard toxicological screenings, its detection can aid in diagnosing mixed intoxications, excluding alternative causes, and facilitating referral to follow-up care. Routine inclusion of ketamine in toxicological screening could improve diagnostic precision and better address the health risks associated with its growing prevalence.

640

News (Medical) associated with Ketamine Hydrochloride

11 Mar 2025

·www.globenewswire.com

PharmaTher Receives US FDA Approval Goal Date for Ketamine

The Assigned FDA Approval Goal Date is June 4, 2025TORONTO, March 11, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company hyper-focused on the commercialization of Ketamine, is pleased to announce today that the Company has received an Amendment Acknowledgement Letter (“AAL”) from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application for Ketamine. In the AAL, the FDA determined this is a minor amendment, meets the criteria for priority review, and assigned an approval goal date of June 4, 2025. Fabio Chianelli, Chairman and CEO of PharmaTher, commented: “I am very pleased with the new FDA approval goal date of June 4, 2025 for our Ketamine drug. We are focused on solving the shortage issue of Ketamine and becoming the leading supplier of Ketamine to fill the demand gap in the U.S. market.” Expecting FDA approval of Ketamine on or before June 4, 2025 As announced on March 3, 2025, PharmaTher provided its resubmission to the complete response amendment and has addressed the deficiencies classified as MINOR in the complete response letter (“CRL”) dated October 22, 2024. In the CRL, the FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the Ketamine submission batches and no new preclinical and clinical studies were requested. No additional deficiencies were mentioned in the AAL. The Company, demonstrating its commitment to quality and compliance, promptly completed the necessary tests and responses to address the FDA’s comments and submitted them to the FDA for their review, which resulted in a new approval goal date of June 4, 2025. Solving the Ketamine shortage problem in the U.S. PharmaTher is committed to solving the Ketamine shortage problem in the United States of America and adhering to the FDA’s strict manufacturing guidelines. Ketamine has been on the FDA’s drug shortage list since February 2018, which is believed to have encouraged the widespread availability of compounded Ketamine products. On October 10, 2023, the FDA published a compounding risk alert describing the potential risks associated with compounded Ketamine products for psychiatric disorders. The outcome with resolving Ketamine’s drug shortage issue would be similar to the recent news of Wegovy and Ozempic being removed from the FDA drug shortage list and compounders have a 60- to 90-day grace period to stop supplying them (see FDA letter). With ketamine removed from the FDA drug shortage list, the FDA is expected to restrict compound pharmacies from supplying it, opening the door for PharmaTher to fill the demand gap in the U.S. market. Unlocking the pharmaceutical potential of Ketamine With pending FDA approval for Ketamine on the horizon, the Company remains focused on its mission to be a leading innovator and provider of Ketamine to treat unmet medical needs. It is well-known that Ketamine is an essential medicine used for anesthesia and analgesia (pain relief), listed on the WHO Essential Medicines List, and used as a sedative and painkiller in hospital settings. Outside of the FDA and Health Canada approved indications, Ketamine is also being administered in hospitals and clinics to treat various pain, neurological, and mental health disorders. A published peer-reviewed study on the real-world effectiveness of Ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation. The potential of Ketamine to significantly impact patient lives is immense. PharmaTher, with its innovative approaches and commitment to patient care, is poised to play a pivotal role in making Ketamine available to millions of people globally. About PharmaTher Holdings Ltd. PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is hyper-focused on the development and commercialization of KETARX™ (Ketamine) to fill the unmet medical needs for surgery, pain, mental health, neurological, and medical countermeasures indications. Learn more at PharmaTher.com. For more information about PharmaTher, please contact: Fabio ChianelliChief Executive OfficerPharmaTher Holdings Ltd.Tel: 1-888-846-3171Email: info@pharmather.com Website: www.pharmather.com Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “closer”, "could", “confident”, "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, “provide”, and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the three and six months ended November 30, 2024 dated January 21, 2025, which is available on the Company's profile at www.sedarplus.ca. This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Priority ReviewNDA

07 Mar 2025

·www.biospace.com

Novo’s Studies of GLP-1s for Addiction Limited to Ongoing Phase II

iStock, Sundry Photography Despite comments made by a Novo Nordisk official this week, the company confirmed to BioSpace that it has no additional clinical trials of its GLP-1 drugs in addiction beyond a Phase II trial testing semaglutide and two other drugs with alcohol use as a secondary endpoint. Thursday, Reuters reported that Martin Holst Lange, head of development at Novo, had told an online conference on Thursday that his company plans to investigate how its GLP-1 medicines can help people with addiction. However, in response to questions from Biospace , a Novo spokesperson said that Lange was referring to already ongoing work studying semaglutide on liver damage and alcohol use, and that the company has no plans to study the drug in broader addiction indications. “There is nothing else in terms of clinical trials we have ongoing in this space at the moment,” the spokesperson said in an email. Novo currently markets its GLP-1 treatments, which both contain the active ingredient semaglutide, as Wegovy for weight loss and Ozempic for type II diabetes. However, there is an early but growing interest in the potential of these molecules to treat substance abuse disorders, their related effects and a bevy of other conditions . The Phase II trial, launched in May 2024 and currently recruiting globally, is studying the effectiveness of semaglutide and two other drugs—cagrilintide, an amylin analogue, and NNC0194-0499, an FGF21 analog—used alone or in combination, in patients with alcoholic liver disease. Treatment of liver damage is that trial’s primary endpoint and alcohol consumption is a secondary endpoint. Three months ago, Novo’s biggest competitor Eli Lilly shared its plans to study its own GLP-1 medicines in alcohol and drug abuse. While Lilly has not officially announced any trials, CEO David Ricks said at an event in December that the company would begin large studies of its obesity drugs in alcohol and drug abuse next year, according to  Endpoints News . Currently, pharmaceutical treatment for addiction and substance-use disorders is limited, with most treatments aimed at avoiding overdoses or reducing withdrawal symptoms. But the industry is attempting inroads, with psychedelic therapies like LSD and ketamine drawing attention from researchers and biopharma companies. Another area of interest is in vaccination. In 2021 the NIH awarded a $25 million grant to scientists at Boston Children’s Hospital to study a vaccine against opioids. The hope is that the vaccine would generate antibodies to prevent the molecules from crossing into the brain. Novo is making progress with GLP-1 on another neurological front. In October 2024, semaglutide was linked with a significant reduction—40% to 70%—in the risk of Alzheimer’s disease in a real-world study of patients with type 2 diabetes. Novo is running two Phase III trials, EVOKE and EVOKE Plus, formally testing semaglutide in patients with Alzheimer’s. Those trials are expected to read out in September of this year.

Phase 2VaccinePhase 3

03 Mar 2025

·www.drugs.com

Death Risk Doubled For ER Patients On Psychedelics

MONDAY, March 3, 2025 -- People who land in the ER after using hallucinogens are more than twice as likely to die in a handful of years, a new study says. Psychedelics users treated at a hospital are 2.6 times more likely than average folks to die from any cause within five years, researchers reported in the Canadian Medical Association Journal . They specifically were more likely to die by suicide, cancer, lung disease and overdose compared to the general public, researchers found. “The findings highlight the need for ongoing investigation of and communication about both potential benefits and risks from hallucinogen use, particularly use outside clinical trial settings, given rapid increases in general population use,” senior researcher Dr. Marco Solmi , an associate professor of psychiatry at the University of Ottawa, said in a news release. The use of hallucinogens like ketamine , psilocybin, LSD, ayahuasca and ecstasy has rapidly increased since the mid-2010s, driven by clinical trials supporting their potential use in treating mental health and substance use disorders, researchers said in background notes. The percentage of U.S. residents reporting that they used hallucinogens more than doubled from nearly 4% in 2016 to almost 9% in 2021, researchers said. However, there isn’t much data on whether these drugs could increase a person’s risk of death when they’re used outside carefully controlled settings, researchers said. For the new study, researchers analyzed records on ER visits or hospitalizations among more than 11.4 million people 15 and older living in Ontario, Canada from 2006 to 2022. Overall, researchers found a 2.6-fold increased risk of early death among people who required treatment after using a hallucinogen. The risk was even higher -- 3.2-fold -- after researchers excluded people who had mental health or substance use disorders, results show. People who required care for hallucinogen use also had increased risks related to specific causes of death: These risks were higher than those of people who sought hospital care linked to alcohol consumption, but lower than people who needed care for opioid or stimulant use, researchers noted. Psychedelics might increase a person’s risk of suicide if they’re used outside a clinical setting researchers said. People taking hallucinogens also might be liable to take other drugs, increasing their risk of overdose. Further, people who needed hospital care for hallucinogen use were more likely to live in low-income neighborhoods, to have been homeless, to have chronic health problems, and to have been treated for a mental health or substance use disorder in the previous three years, researchers added. “Despite the growing popularity of hallucinogen use, we know surprisingly little about potential adverse effects of hallucinogens, such as mortality risks,” lead researcher Dr. Daniel Myran , research chair in social accountability at the University of Ottawa, said in a news release. “Contemporary clinical trials have not observed any short-term increase in risk of severe adverse events, including death, for trial participants,” Myran said. “However, these studies involve careful supervision and therapy for trial participants and exclude people at high risk of adverse outcomes.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

100 Deals associated with Ketamine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00711	Ketamine Hydrochloride	N01AX03	DBSALT000396

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anesthesia	United States	Endo Operations Ltd.	19 Feb 1970
Pain	Canada	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bipolar and Related Disorders	Phase 3	United States	NeuroRx, Inc.	30 Jan 2022
Depressive Disorder	Phase 3	United States	NeuroRx, Inc.	25 Jun 2019
Suicidal Ideation	Phase 3	United States	NeuroRx, Inc.	25 Jun 2019
Alcohol Use Disorder	Phase 3	United Kingdom	Awakn Life Sciences Corp.	-
Acute Pain	Phase 2	-	iX Biopharma Ltd.	-
Alcoholism	Phase 2	North America	Awakn Life Sciences, Inc.	-
Parkinsonian Disorders	Phase 2	United States	PharmaTher Holdings Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02651324 (CTgov)	Phase 4	Idiopathic scoliosis \| Pain, Postoperative	50	Ketamine (Treatment Group)	lrfzqvsexw(mcwsetnzpo) = cohtfdxwle jrxgxanuzx (dgpxkzljxu, pyzzxfcyic - wbgwzqziyy) View more	-	20 Feb 2025
				Placebo (Placebo)	lrfzqvsexw(mcwsetnzpo) = rmypncwhsc jrxgxanuzx (dgpxkzljxu, vmmgdrhnmp - dabxobjbsj) View more
NCT04625283 (CTgov)	Phase 4	Anesthesia \| Pain, Postoperative	1,570	Ketamine (Ketamine)	(kbcuxjknrv) = qnwvjijcxj azywsdfmwu (lhvkncvffc, byjsxfndji - ovzhgnovki) View more	-	04 Feb 2025
				Placebo (Saline)	(kbcuxjknrv) = ivxvopxhxw azywsdfmwu (lhvkncvffc, iaxphacumv - vfmrvsgvgx) View more
NCT04260607 (CTgov)	Phase 3	Depressive Disorder \| Suicidal Ideation	1	Ketamine Hydrochloride (Experimental-Ketamine)	jwpvntcsvj(wvjedcxrfl) = tjcyymxftf gelehkzyce (kwhphagsjt, sessqylmtk - poontxaicu) View more	-	19 Nov 2024
				normal saline (Placebo-Saline)	snwxsobcxh(gtxqalzhud) = fulztffdfx wcaaiwkbem (dktogbofru, kxtwvcnnng - clcenxvqhg) View more
NCT04889664 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	16	Written Exposure Therapy+ketamine	yslwflbevx(xmmggohbhi) = ytidlsgwcx yybnlfeobg (zxyevnjezj, cjorpbfuxc - crlfnvzvap) View more	-	08 Oct 2024
SFN2024	Not Applicable	Schizophrenia	-	Ketamine	qonhkshgdi(mcxizikxbr) = ulegdgsiut mvvfmsnyce (qscifeybjr ) View more	-	05 Oct 2024
				Saline	qonhkshgdi(mcxizikxbr) = rxlszhmors mvvfmsnyce (qscifeybjr )
NCT04916548 (CTgov)	Phase 1/2	Depressive Disorder	15	Intravenous Ketamine	vkglgfmzix(uhaihcryhc) = judyfzddvk ouxmbtibly (ocvvttxxop, xwfsnijbrm - bhvjlskctp) View more	-	20 Aug 2024
NCT05168735 (CTgov)	Phase 1/2	Depressive Disorder	43	Brief Mindfulness Exercises+Intravenous Ketamine (Intravenous Ketamine + Mindfulness Exercises)	(wbshmymfim) = ljvoukgdgc qfyentqbqa (hcjkocfaaw, jvizgluiab - fnuummhfrh) View more	-	20 Aug 2024
				Academic Exercises+Intravenous Ketamine (Intravenous Ketamine + Academic Exercises)	(wbshmymfim) = kqjmlhvflg qfyentqbqa (hcjkocfaaw, lvgszyaeem - kixlivokgm) View more
NCT05957302 (Pubmed \| J Anesth) Manual	Not Applicable	Shock, Septic	86	Ketamine 1 mg/kg	pppsvrezej(aehqilwpoo) = ceegjvrqsq wbztoatmvm (yfdlhgzrau )	Positive	18 Aug 2024
				fentanyl 1 mg/kg	pppsvrezej(aehqilwpoo) = fapsenfvzc wbztoatmvm (yfdlhgzrau )
NCT04947085 (CTgov)	Phase 4	Pain	150	Ketamine via Intravenous (IV SDK)	mzamcczhmy(ftrukmhwqo) = swapyhhjsj xjmhqykgsp (iavxmilpwy, hbxotgunfh - jvumuhcklk) View more	-	03 Jul 2024
				Ketamine via BAN (K-BAN)	mzamcczhmy(ftrukmhwqo) = etxwqeidfc xjmhqykgsp (iavxmilpwy, gqliljokaz - aptrjdecim) View more
NCT06236113 (CTgov)	Phase 4	Rib Fractures	50	Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution (Placebo/Control)	ocezcsbqyo(zkfjlusykq) = khowffwqtv dfhtzmtcfn (jwapyfwotl, unyeksoatt - hhgzlzywou) View more	-	21 May 2024
				Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution (Low Dose Ketamine Infusion (LDKI))	ocezcsbqyo(zkfjlusykq) = qpwjtwxfsb dfhtzmtcfn (jwapyfwotl, nwtwvppjdq - idvisdwzlt) View more