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Last update 28 Jan 2026

Fentanyl Citrate

Last update 28 Jan 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Abstral Sublingual, E-Fen Buccal, Fentanyl citrate (JP17/USP)

+ [33]

Target

μ opioid receptor

Action

agonists

Mechanism

μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System DiseasesUrogenital DiseasesOther Diseases

Active Indication

Breakthrough PainCancer PainHyperemesis Gravidarum+ [1]

Inactive Indication

Anemia, Sickle CellBurnsChronic Pain+ [9]

Originator Organization

Rising Pharmaceuticals, Inc.

Active Organization

Istituto Gentili Srl

Grünenthal GmbH

Phoenix Labs

+ [5]

Inactive Organization

BTcP Pharma LLC

Cephalon, Inc.

Exela Pharma Sciences LLC

+ [6]

License Organization

Kunwha Pharmaceutical Co., Ltd.

Daiichi Sankyo Co., Ltd.

Collegium Pharmaceutical, Inc.

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (19 Feb 1968),

Anesthesia

Regulation-

Structure/Sequence

Molecular FormulaC28H36N2O8

InChIKeyIVLVTNPOHDFFCJ-UHFFFAOYSA-N

CAS Registry990-73-8

1,151

Clinical Trials associated with Fentanyl Citrate

ChiCTR2600115977

/ Not yet recruitingNot ApplicableIIT

Optimization of ERAS management model in the perioperative period of pediatric day surgery: evaluating the effectiveness and safety of low-opioid multimodal analgesia strategy.

Start Date06 Jan 2026

Sponsor / Collaborator-

ChiCTR2600116718

/ Not yet recruitingEarly Phase 1IIT

Comparison of the Effects of Remimazolam and Propofol on Emergence Delirium in Children Undergoing General Anesthesia

Start Date01 Jan 2026

Sponsor / Collaborator

The First Affiliated Hospital of Xiamen University

NCT07347886

/ Not yet recruitingNot ApplicableIIT

Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia

This study aims to evaluate the clinical outcomes of different sedation strategies in patients undergoing cataract surgery performed under topical anesthesia. Cataract surgery is commonly performed under topical anesthesia; however, some patients may experience anxiety, discomfort, or inadequate cooperation during the procedure. Sedation may improve patient comfort and surgical conditions, but it may also be associated with potential adverse effects.
In this randomized, prospective study, patients will be assigned to one of three groups: topical anesthesia alone, topical anesthesia combined with midazolam, or topical anesthesia combined with midazolam and fentanyl. Intraoperative sedation levels, hemodynamic parameters, patient satisfaction, and surgeon satisfaction will be assessed and compared among the groups.
The results of this study are expected to provide evidence regarding the effectiveness and safety of sedation during cataract surgery performed under topical anesthesia and to help optimize perioperative sedation strategies for these patients.

Start Date01 Jan 2026

Sponsor / Collaborator-

100 Clinical Results associated with Fentanyl Citrate

100 Translational Medicine associated with Fentanyl Citrate

100 Patents (Medical) associated with Fentanyl Citrate

7,571

Literatures (Medical) associated with Fentanyl Citrate

09 Jan 2026·Science Advances

Three-component synthesis of β-thio tertiary alkylamines from simple alkenes via S _H 2 homolytic substitution

Article

Author: Bao, Yongli ; Wang, Hongyu ; Wang, Ting ; He, Qianyu ; Zhang, Qian ; Zhao, Yongyun ; Fu, Junkai ; Guan, Xinyu ; Li, Yang ; Ma, Wenxuan ; Zheng, Chao ; Vasdev, Neil ; Li, Yifei

Alkene difunctionalization via electrophilic aminyl radical cations offers a straightforward route to complex tertiary alkylamines widely occurring in biologically active molecules. However, only a limited variety of third reaction components have been hitherto introduced because of the challenges in capturing transient C(sp 3 )-centered radical intermediates under acidic conditions, and structurally specific alkenes are usually required. Herein, we report a copper-catalyzed three-component aminothiolation reaction, enabling the first incorporation of S-based functionalities across simple alkenes to synthesize β-thio tertiary alkylamines. This protocol works well for both aryl and unactivated alkenes with a broad functional group compatibility and is applicable to ─SCF 3 , ─SCN, and ─SBz groups. Mechanistic investigations reveal a key bimolecular homolytic (S H 2) substitution process that efficiently traps the nascent C(sp 3 )-centered radical intermediates in acidic media and facilitates the C─S bond formation with high regioselectivity and even primary enantiocontrol. The introduced S-based functionality can improve the performance of pharmaceuticals such as Fentora.

01 Jan 2026·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Femoral nerve block vs IV fentanyl for hip fracture pain in the emergency department: A randomized double-blind clinical trial

Article

Author: Sanri, Erkman ; Kudu, Emre ; Gunduz, Osman Hakan ; Unal, Emir ; Altunbaş, Erhan ; Karacabey, Sinan

BACKGROUND:

Hip fractures frequently cause severe pain and functional decline in adults presenting to emergency departments (EDs). Although intravenous (IV) opioids are widely used for pain control, their use may be limited by adverse effects, especially in patients with comorbidities or cognitive impairment. Ultrasound-guided femoral nerve block (FNB) offers a regional analgesic technique that may provide effective pain relief while reducing opioid-related complications. However, comparative randomized trials in the ED setting remain limited.

METHODS:

In this single-center, randomized, double-blind clinical trial, adult patients with radiologically confirmed hip fractures were assigned to receive either ultrasound-guided FNB (20 mL 0.5 % bupivacaine) or IV fentanyl (1 μg/kg). To preserve blinding, patients in each group received a placebo injection mimicking the alternative treatment. Pain severity was measured at baseline and 20 min post-intervention using the Numeric Pain Rating Scale or the Pain Assessment in Advanced Dementia Scale (PAINAD), based on cognitive status. The primary outcome was change in pain score at 20 min. Secondary outcomes included rescue analgesia requirement within four hours and adverse events.

RESULTS:

A total of 104 patients were enrolled and randomized. The FNB group experienced greater median pain reduction compared to the fentanyl group (4 [IQR 3-5] vs. 2 [IQR 2-3]; median difference: 2, 95 % CI: 1-2). Rescue analgesia was required in 21.1 % of FNB patients versus 61.5 % in the fentanyl group. Adverse events were observed only in the fentanyl group, including nausea (23 %), dizziness (15 %), headache (9.6 %), and hypotension (5.7 %). No FNB-related complications were reported. Subgroup analysis showed consistent efficacy among cognitively impaired patients.

CONCLUSION:

FNB resulted in superior analgesia, fewer side effects, and lower need for rescue opioids compared to IV fentanyl. Additionally, FNB has shown an effective and safe pain control in patients with cognitive impairment compared to patients without cognitive impairment.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT06862154.

01 Dec 2025·LANCET

Comparison of inhalational methoxyflurane, intranasal fentanyl, and intravenous morphine for treatment of prehospital acute pain in Norway (PreMeFen): a randomised, non-inferiority, three-arm, phase 3 trial

Article

Author: Heyerdahl, Fridtjof ; Smalberget, Live ; Simensen, Randi ; Rehn, Marius ; Hagemo, Jostein ; Thorsen, Kjetil ; Fjose, Lars Olav ; Olsen, Inge Christoffer

BACKGROUND:

Adequate pain control is essential; however, acute pain is often undertreated in prehospital care. This study aimed to evaluate three analgesic regimens for treating acute pain in an ambulance setting.

METHODS:

PreMeFen is a randomised, open-label, non-inferiority, three-arm, phase 3 trial conducted in the working areas of the ground ambulance service of the Innlandet Hospital Trust, Norway. Patients aged 18-69 years and 70 years and older with traumatic or medical acute pain scoring 4 or higher on the Numeric Rating Scale (NRS) were randomly assigned (1:1:1) to receive in titration doses 3 mL inhalational methoxyflurane, 50 μg or 100 μg intranasal fentanyl, or 0·05 mg/kg or 0·1 mg/kg intravenous morphine, respectively, depending on the age group. The primary endpoint was change in pain NRS score from baseline to 10 min after treatment start and was analysed per protocol. The non-inferiority margin was 1·3. This trial is registered with ClinicalTrials.gov (NCT05137184) and is completed.

FINDINGS:

Between Nov 12, 2021, and April 22, 2023, 632 patients were assessed for eligibility, and 338 were randomly assigned to methoxyflurane (n=112), fentanyl (n=115), or morphine (n=111). 281 patients were included in the per-protocol population. 145 (52%) of 281 patients were female and 136 (48%) were male. Median age was 61 years (IQR 47-75). The baseline NRS score was 7·6 (SD 1·8). Mean NRS score changes after 10 min were -3·31 (SD 2·67) for methoxyflurane, -1·98 (2·28) for fentanyl, and -2·74 (2·12) for morphine. Comparing changes in mean NRS score while adjusting for baseline showed that methoxyflurane was non-inferior to fentanyl (-1·33 [95% CI -2·01 to -0·64]) and morphine (-0·36 [-1·03 to 0·31]). Intranasal fentanyl was not non-inferior to morphine at 10 min (0·91 [0·27 to 1·55]). Adverse events occurred in 26 (24%) of 109 patients in the morphine group, 27 (24%) of 112 in the fentanyl group, and 24 (22%) of 111 in the methoxyflurane group. Two serious adverse events, respiratory depression (grade 2) and loss of consciousness (grade 3), occurred in the same patient in the methoxyflurane group. There were no treatment-related deaths.

INTERPRETATION:

Inhalational methoxyflurane is non-inferior to intranasal fentanyl and intravenous morphine for acute pain management in the prehospital environment, assessed 10 min after administration. Inhalational methoxyflurane serves as a valuable non-intravenous alternative in the early phase of treatment and might bridge the gap to longer-acting analgesics.

FUNDING:

Norwegian Air Ambulance Foundation and Innlandet Hospital Trust.

News (Medical) associated with Fentanyl Citrate

06 Jan 2026

·www.sciencedaily.com

Scientists find a safer way for opioids to relieve pain

Researchers at USF Health have discovered a new way opioid receptors can work that may lead to safer pain medications. Their findings show that certain experimental compounds can amplify pain relief without intensifying dangerous side effects like suppressed breathing. This research offers a fresh blueprint for designing opioids that last longer, work better, and pose fewer risks. It also opens doors to safer treatments for other brain disorders.Scientists at USF Health are making major progress in understanding how new opioid compounds interact with the body to relieve pain. Their work is raising optimism that future pain medications could deliver relief without the life-threatening side effects associated with today's opioids. Their latest findings were published December 17 in Nature under the title "GTP release-selective agonists prolong opioid analgesic efficacy." A companion study, "Characterization of the GTPγS release function of a G protein-coupled receptor," appeared the same day in Nature Communications. "Our overarching research aims to understand how opioids work so that we can ultimately provide safer options for chronic pain and develop therapies for opioid use disorders," said senior author Laura M. Bohn, PhD, senior associate dean for Basic and Translational Research and professor of Molecular Pharmacology and Physiology at the USF Health Morsani College of Medicine. How Opioids Relieve Pain and Cause Harm The studies focus on a group of experimental pain-relieving compounds that act on mu opioid receptors. These receptors are proteins found on nerve cells that reduce pain signals when activated by opioids such as morphine. However, activating these receptors also triggers serious side effects. Drugs like morphine can slow breathing, a dangerous effect that contributes to overdose deaths. Dr. Bohn and her team are working to develop compounds that ease pain without causing these harmful reactions. Their research reveals previously unknown ways opioid receptors behave when different drugs bind to them. New Insights Into Receptor Behavior Although the research is not expected to produce a new medication right away, it significantly improves scientific understanding of how receptors function, said Edward Stahl, PhD, assistant professor of Molecular Pharmacology and Physiology at the Morsani College of Medicine and a corresponding author on the study, which received funding from the National Institutes of Health. "Our manuscripts describe a unique way that drugs can control receptors," Dr. Stahl said. "Fundamentally, knowing more about how receptors work is the first step in understanding how to drug them and how to drug them safer. If this research is further validated, it would add to our textbook knowledge of how receptors function and, more importantly, to our ability to treat human health and disease." Reversing the Opioid Signal When opioids bind to a receptor, they trigger a sequence of events inside the cell that leads to pain relief and side effects. Long-term use of drugs such as morphine, oxycodone, and fentanyl often results in tolerance and dangerous breathing suppression. The researchers discovered that the earliest step in this signaling process can move in reverse. Some compounds appear to favor this backward reaction instead of pushing the process forward. "We've found that the first step of the chain reaction is reversible, and that some drugs can favor a reverse reaction over the forward reaction," Dr. Bohn said. "We've studied two new chemicals that strongly favor the reverse cycle and, when administered at non-effective doses, can enhance morphine and fentanyl-induced pain relief while not enhancing the respiratory suppression effects." Promising Frameworks, Not Final Drugs The newly studied molecules are not considered drug candidates. At higher doses, they still suppress breathing and have not undergone testing for toxicity or other opioid-related side effects. Even so, they provide valuable guidance for future drug design. "They do provide the framework for building new drugs," Dr. Bohn said. Building on Earlier Breakthroughs Dr. Bohn's laboratory previously identified a compound known as SR-17018. Unlike traditional opioids, SR-17018 does not cause breathing suppression or tolerance. It activates the same opioid receptor targeted by morphine, oxycodone, and fentanyl, but it attaches in a different way that leaves the receptor available for the body's own natural pain-relieving chemicals. While SR-17018 also favors the reverse signaling direction, researchers believe other features contribute to its improved safety profile. "For this reason," Dr. Bohn said, "we will be using our new findings to improve upon SR-17018." Broader Implications Beyond Pain Relief The research could influence drug development beyond opioids. Other receptors, including the serotonin 1A receptor, may also be activated in a reverse direction. According to Dr. Bohn, "this is an important drug target in neuropsychiatric disorders, including depression and psychosis." Context Within the Opioid Crisis These discoveries arrive amid an ongoing public health emergency linked to opioid misuse. Data show that opioids were involved in 68 percent of overdose deaths in 2024, with fentanyl and other synthetic opioids accounting for 88 percent of those fatalities. Dr. Bohn, an internationally recognized expert in molecular pharmacology and neurobiology, recently joined USF Health. She is widely known for her groundbreaking research on G protein-coupled receptors (GPCRs), the largest class of drug targets in the human body. Her lab has played a key role in revealing how selective signaling at opioid receptors can reduce pain without causing breathing suppression or tolerance. These findings deepen scientific understanding of opioid biology and move researchers closer to developing safer, non-addictive pain treatments.

17 Dec 2025

·www.indivior.com

New Study Shows Extended-Release Buprenorphine Safely Delivers Rapid, Clinically Meaningful Reductions in Opioid Use and Supports Abstinence in High-Risk Populations

Both monthly maintenance doses (100 mg and 300 mg) improved opioid abstinence and were well-tolerated with no new safety signals identified. Post-hoc analyses indicated the 300-mg monthly maintenance dose performed significantly better than the 100-mg monthly dose in participants reporting high-frequency fentanyl use. Richmond, VA – December 17, 2025 – Indivior PLC (Nasdaq: INDV) today announced results from a randomized, double-blind clinical trial published in JAMA Network Open. The study found that both the 100-mg and 300-mg monthly maintenance doses of SUBLOCADE® (extended-release buprenorphine) rapidly reduced opioid use and improved opioid abstinence and were well tolerated, with no new safety signals in individuals with moderate-to-severe opioid use disorder (OUD). Participants across both dose groups experienced a rapid reduction in opioid use—from more than 43 instances per week at screening to fewer than three instances per week by week three—a decline maintained through week 38. Post-hoc analyses also identified a subset of individuals who may benefit from the higher 300-mg maintenance dose of extended-release buprenorphine. Participants who used fentanyl daily and/or 14 or more times per week had significantly higher opioid abstinence rates with 300-mg dose compared to 100 mg, suggesting a population that may potentially benefit from the higher maintenance dose regimen. “These findings offer evidence to consider for clinicians navigating the complexities of OUD in the fentanyl era,” said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. “By demonstrating that extended-release buprenorphine improves abstinence, even among those with high-frequency fentanyl use, we underscore the need for treatment approaches that adapt to the realities of today’s opioid crisis and give patients the best chance at recovery.” Injection-site reactions were more common in the 300-mg arm but were mild to moderate and were not associated with discontinuation. Study limitations include the exploratory nature of the post-hoc analyses, which were not pre-specified in the trial’s statistical analysis plan. About SUBLOCADE® SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII INDICATION AND HIGHLIGHTED SAFETY INFORMATION INDICATION SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. HIGHLIGHTED SAFETY INFORMATION WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. CONTRAINDICATIONS Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE. WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. Risk of Serious Injection Site Reactions: Likelihood of may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration and necrosis. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. ADVERSE REACTIONS Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit www.sublocade.com. About Opioid Use Disorder (OUD) Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences. OUD may affect the parts of the brain that are necessary for life-sustaining functions. About Indivior Indivior Pharmaceuticals works to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a human crisis to a recognized and treated chronic disease. Building on its portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. Media Contact Erin Berst Director, Communications Indivior PLC Indiviormediacontacts@indivior.com

Clinical ResultPhase 3

11 Dec 2025

·www.globenewswire.com

Polyrizon Announces Promising Permeation Kinetics Supporting Advancement of Its Intranasal Naloxone Hydrogel Program

Ra’anana, Israel, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced new results from its ongoing preclinical evaluation of its proprietary intranasal naloxone hydrogel formulation, demonstrating promising permeation kinetics that complement the Company’s previously reported stability and mucoadhesion successes. Following the positive mucoadhesion findings-where Polyrizon’s formulation showed significantly enhanced persistence on ex-vivo nasal tissue compared to a marketed intranasal naloxone product (p < 0.0001) -the Company has completed a dedicated series of permeation studies using a validated artificial membrane system. These studies assessed the rate and extent of naloxone diffusion from Polyrizon’s hydrogel in comparison with the commercially available reference product under controlled conditions. Importantly, despite the improved mucoadhesion demonstrated by Polyrizon’s formulation, permeation profiles remained rapid, with no statistically significant differences in permeation kinetics when compared to the marketed naloxone product. This indicates that the hydrogel’s enhanced residence time on the nasal mucosa does not impede or delay drug permeation, potentially preserving the fast-acting characteristics required for emergency opioid overdose reversal. Collectively, the results from three independent data pillars: Stability studies demonstrating robustness of the formulation,Mucoadhesion studies showing superior and statistically significant tissue retention, andPermeability studies confirming rapid diffusion comparable to the commercial benchmark- strongly position Polyrizon’s naloxone hydrogel candidate for potential advancement into further development stages. These findings reinforce the potential of Polyrizon’s Trap & Target™ technology to deliver an innovative intranasal naloxone product that combines enhanced mucosal residence time with the essential fast-onset pharmacokinetic behavior expected in real-world emergency scenarios. The need for improved naloxone delivery systems continues to grow as the opioid crisis escalates worldwide. According to the U.S. Centers for Disease Control and Prevention (CDC), in the United States alone, opioid overdoses account for more than 80,000 deaths annually, with synthetic opioids such as fentanyl driving rapid-onset, high-severity emergencies that demand fast, reliable intervention. According to Vantage Market Research the global naloxone market is expanding in response, projected to reach several billion dollars over the next few years, driven by increasing public health initiatives, broader community access programs, and regulatory support for innovative rescue products. Intranasal formulations remain the preferred route of administration due to their ease of use, rapid action, and suitability for lay responders. Within this landscape, technologies capable of enhancing mucosal retention without compromising permeation kinetics, such as Polyrizon’s Trap & Target™ hydrogel, have the potential to meaningfully elevate treatment reliability and improve real-world outcomes during opioid overdose events. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses potential advancement of its naloxone hydrogel candidate into further development stages, the potential of Polyrizon’s Trap & Target™ technology to deliver an innovative intranasal naloxone product that combines enhanced mucosal residence time with the essential fast-onset pharmacokinetic behavior expected in real-world emergency scenarios, the expected growth of the global naloxone market and the Company’s potential to meaningfully elevate treatment reliability and improve real-world outcomes during opioid overdose events. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 11, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites. Contacts: Michal Efraty Investor Relations IR@polyrizon-biotech.com

Clinical Result

100 Deals associated with Fentanyl Citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D01399	Fentanyl Citrate	N02AB03 N01AH01	DB00813

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pain	United States	Adalvo Ltd.	16 Jul 2009
Breakthrough Pain	European Union	Phoenix Labs	04 Apr 2008
Breakthrough Pain	Iceland	Phoenix Labs	04 Apr 2008
Breakthrough Pain	Liechtenstein	Phoenix Labs	04 Apr 2008
Breakthrough Pain	Norway	Phoenix Labs	04 Apr 2008
Cancer Pain	United States	Cephalon, Inc.	04 Nov 1998
Hyperemesis Gravidarum	China	Yichang Humanwell Pharmaceuticals Co., Ltd.	01 Jan 1981
Anesthesia	United States	Rising Pharmaceuticals, Inc.	19 Feb 1968

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Head and Neck Neoplasms	Phase 3	Italy	L. Molteni & C. dei F.lli Alitti Società di Esercizio SpA	01 Sep 2014
Respiratory Insufficiency	Phase 3	-	BioDelivery Sciences International, Inc.	01 Jun 2008
Chronic Pain	Phase 3	United States	Cephalon, Inc.	01 Dec 2006
Complex Regional Pain Syndromes	Phase 3	United States	Cephalon, Inc.	01 Sep 2005
Low Back Pain	Phase 3	United States	Cephalon, Inc.	01 Sep 2005
Neuralgia	Phase 3	United States	Cephalon, Inc.	01 Sep 2005
Neuralgia, Postherpetic	Phase 3	United States	Cephalon, Inc.	01 Sep 2005
Neoplasms	Phase 3	-	Cephalon, Inc.	01 Jun 2004
Dyspnea, Paroxysmal	Phase 2	Germany	Teva Branded Pharmaceutical Products R&D, Inc.	01 Mar 2013
Lung Cancer	Phase 2	Germany	Teva Branded Pharmaceutical Products R&D, Inc.	01 Mar 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06862154 (Pubmed \| Am J Emerg Med)	Phase 4	Fracture pain	104	Ultrasound-guided Femoral Nerve Block (FNB) 0.5% bupivacaine	qmoqsmnfez(vojbuopjjf) = naggtyucyw mystofrjxq (ioalwxepej, 3 - 5) View more	Positive	01 Jan 2026
				IV Fentanyl	qmoqsmnfez(vojbuopjjf) = vmwmpqxkps mystofrjxq (ioalwxepej, 2 - 3) View more
NCT06862154 (CTgov)	Phase 4	Analgesia \| Femoral Neuropathy \| Femoral Neck Fractures ... View more	104	Femoral Nerve Block (Femoral Nerve Block)	rsastktlfl(xqpzzdrzps) = immameuftf imtelonrce (tmrxvyydrs, ytrwunnuaq - osqwckdjmw) View more	-	05 Dec 2025
				Fentanyl (IV Analgesia-Fentanyl)	rsastktlfl(xqpzzdrzps) = usvjnqdfoj imtelonrce (tmrxvyydrs, thgifuaixy - tsrvbbwoea) View more
NCT05137184 (PreMeFen, Pubmed \| Lancet)	Phase 3	Acute Pain	281	Inhalational methoxyflurane	lgbdmytsnr(nzdqsyszcd) = ouvuntagul nuopvunnkz (zdrwyrrivc ) View more	Positive	01 Dec 2025
				Intranasal fentanyl	lgbdmytsnr(nzdqsyszcd) = rxevxxedwp nuopvunnkz (zdrwyrrivc )
NCT03726268 (OSPREy, CTgov)	Phase 4	Pain, Postoperative	907	Methadone (Short-stay, IV Methadone)	vvdhidtxjo(vpmbcqhhpe) = exhrqxuvvd czirhgqgvw (xzvapfiebg, 15.50) View more	-	19 Nov 2025
				Fentanyl+Hydromorphone+Sufentanil+Morphine (Short-stay, IV Short-acting Opioids)	vvdhidtxjo(vpmbcqhhpe) = rqnjzcrnlg czirhgqgvw (xzvapfiebg, 11.60) View more
NCT04230681 (CTgov)	Early Phase 1	Sleep Apnea, Obstructive \| Tonsillitis	189	Hydromorphone (Hydromorphone)	pbychobgrh = pxqamhrwdr ahsuoslqnc (lagzeyweqz, ccxscyhntq - hvzlbptexc) View more	-	18 Dec 2024
				Fentanyl (Fentanyl)	pbychobgrh = kbqjoubpif ahsuoslqnc (lagzeyweqz, mscdqowsbo - fepkinhmjt) View more
WCLC2024 Manual	Phase 3	Sedation	84	Midazolam with Fentanyl	hingbtgkfr(qelkdvibms) = hzovlnriuh fqxwfuuqbe (barkrfiaoz ) View more	Positive	07 Sep 2024
				Midazolam with Placebo	hingbtgkfr(qelkdvibms) = ihslfzrtba fqxwfuuqbe (barkrfiaoz ) View more
NCT03435003 (CTgov)	Phase 4	Postoperative Nausea and Vomiting \| Vomiting	83	dexmedetomidine+Total intravenous anesthesia+Fentanyl+scopolamine transdermal+Compazine+sugammadex+Reglan+Propofol+Dexamethasone+Ondansetron+Aprepitant 80 mg Oral Capsule (Intervention Arm)	ervmkqwjnr = ipzncocqud xvirykmrau (aidslmexzd, wjtelbkwlm - xlpozmxblo) View more	-	14 Feb 2024
				Compazine+sugammadex+Reglan+Sevoflurane+Dexamethasone+desflurane+Ondansetron (Control Arm)	ervmkqwjnr = dhqwirlfhq xvirykmrau (aidslmexzd, zpgteyhrfp - kzrfrhalbi) View more
NCT03115151 (CTgov)	Phase 4	Pain	46	Fentanyl+Bupivacaine (Patient-Controlled Epidural Analgesia)	tbecwcivra(szhpcsjaxm) = yjnbxqizcy ltcgnnfxgr (cglrklkumg, 24.69) View more	-	26 Oct 2023
				Hydromorphone (Intravenous Patient-controlled Analgesia)	tbecwcivra(szhpcsjaxm) = tslclxhvqk ltcgnnfxgr (cglrklkumg, 25.41) View more
NCT02604459 (OPCare, CTgov)	Not Applicable	Anesthesia \| Emergence Delirium \| Hip Fractures	145	General anesthesia+fentanyl+propofol+sevoflurane (Mini Mental State Exam)	trdxvsgpnm(vzfeldpppy) = qrzuxokctu goxauedzpp (kouaeekbmi, 0.49) View more	-	17 Oct 2023
				General anesthesia+fentanyl+propofol+sevoflurane (Tested and Excluded)	umkjnixunv(lfdrbmjjve) = talrnhkydi atuqxbzmdj (kbjxhobvjk, vdpnesriqs - mujosxcqfx) View more
NCT01488045 (CTgov)	Not Applicable	Diverticulosis, Colonic \| Rectal Cancer \| Colonic Cancer	289	Propofol (Propofol Intervention)	xrwmieildr(swetzfpxha) = nukpylpiip cppzuvcmzg (nsxlypiocf, 12.8) View more	-	23 May 2023
				Fentanyl+Midazolam (Midazolam/Fentanyl Intervention)	xrwmieildr(swetzfpxha) = stshtrgjuv cppzuvcmzg (nsxlypiocf, 28.3) View more

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