Delving into the Latest Updates on Articaine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Articaine, Articaine hydrochloride (JAN/USP), 40-045

+ [7]

Target

SCNA

Action

blockers, modulators

Mechanism

SCNA blockers(Sodium voltage-gated channel alpha subunits blockers), Central nervous system modulators

Therapeutic Areas

Other Diseases

Active Indication

Anesthesia

Inactive Indication-

Originator Organization

North American Genomics LLC

Active Organization-

Inactive Organization

North American Genomics LLC

Thea Pharma Inc.American Genomics, LLC

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (15 Aug 2025),

Anesthesia

Regulation-

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Structure/Sequence

Molecular FormulaC13H21ClN2O3S

InChIKeyGDWDBGSWGNEMGJ-UHFFFAOYSA-N

CAS Registry23964-57-0

Military dental providers often operate in environments with extreme temperature gradients. The purpose of this study was to analyze the effect of simulated storage in extreme cold conditions on 8 medications—4 local anesthetics (2% Lidocaine with 1:100,000 epinephrine, 0.5% Marcaine with 1:200,000 epinephrine, 4% Articaine with 1:100,000 epinephrine, 3% Polocaine), 2 pain medications (Acetaminophen 325 mg, Ibuprofen 800 mg), and 2 antibiotics (Amoxicillin 500 mg, Azithromycin 500 mg), who are commonly used by the military for dental treatment.

Materials and Methods:

Medications were subjected to simulated freeze-thaw (FT) conditions (MIL-STD-810H), using an environmental chamber to expose any tendency for degradation. The medications were cycled through 13 hours at −10 °C and 11 hours at 4 °C for 28 days, to simulate springtime FT conditions experienced by Kyiv, Ukraine. Samples were analyzed at 0, 7, 14, 21, and 28 days under both environmental stress and room temperature (RT) conditions. Liquid chromatography—mass spectrometry (LC-MS) was completed with electrospray ionization interface and triple quadrupole mass analyzer. Each medication was used as an internal standard (IS) for the other and response factors determined for each. All drugs and their respective IS were measured in multiple reaction monitoring in electrospray positive ionization. Room temperature data from each time point were compared to the respective environmentally stressed drug data using T-tests adjusted via Bonferroni’s method (α = 0.01). Parametric first-order autoregressive moving-average repeated-measures analysis of variance using maximum likelihood was performed using the “MIXED” procedure in SAS v9.4 to determine if concentrations were affected by time and environmental stress (α = 0.05).

Results:

Lidocaine, Polocaine, Acetaminophen, and Azithromycin concentrations were affected by time and environmental stressing. All other medication concentrations were affected by time but not by environmental stressing.

Conclusions:

Utilization and/or storage of commonly used local anesthetics, antibiotics, and pain medications in these climate conditions may experience concentration changes who may affect their efficacy in treating dental-related conditions.

01 Feb 2026·JOURNAL OF ENDODONTICS

Evaluation of Articaine Infiltration Location on the Success Rate of Mandibular Lateral Incisor Anesthesia: A Prospective Crossover Randomized Clinical Trial Study

Article

Author: Adl, Alireza ; Sobhnamayan, Fereshte ; Alimardani, Fahime

INTRODUCTION:

Effective anesthesia of the mandibular lateral incisor is challenging. This study compared the efficacy of lingual infiltration alone versus combined labial and lingual infiltration using 4% articaine with 1:100,000 epinephrine.

METHODS:

In this prospective, randomized, crossover clinical trial, 50 healthy volunteers received 2 infiltration techniques: (1) lingual infiltration only (3.6 mL total via 2 1.8 mL injections plus a mock buccal injection), and (2) combined labial and lingual infiltration (1.8 mL each; 3.6 mL total plus a mock lingual injection). Anesthetic success was evaluated by: (1) absence of response to maximal electronic pulp tester stimulation, (2) sustained anesthesia defined as no response within 16 minutes lasting 42 minutes, and (3) anesthesia onset time (first of two consecutive no-response readings). Pain during injection was assessed via the 170-mm Heft-Parker visual analog scale. Statistical tests included McNemar's, Wilcoxon signed-rank, Friedman, and Dunn's test.

RESULTS:

The combined technique produced an equal or higher success rate (P ≤ .05), significantly greater sustained anesthesia (P < .05), and a significantly shorter onset time (P < .05) compared with lingual infiltration alone. Labial infiltration was associated with higher pain scores, especially during solution deposition (P < .05).

CONCLUSIONS:

The combination of labial and lingual infiltration with 4% articaine and 1:100,000 epinephrine significantly improves the anesthetic success and duration for the mandibular lateral incisor, although it is associated with increased injection-related pain.

01 Feb 2026·Journal of conservative dentistry and endodontics

A comparative clinical study to evaluate the efficacy of lignocaine 2% and articaine 4% for anesthesia of mandibular first molars with irreversible pulpitis

Article

Author: Prasad, V. V. S. Ram ; Karan, Smita ; Saraf, Suma P. ; Saraf, Prahlad A. ; Zinge, Priyanka R ; Ratnakar, P.

Abstract:

Introduction::

Achieving anesthesia in mandibular molars with irreversible pulpitis (IP) is quite challenging. This study highlights the efficacy of two clinically effective local anesthetic agents – lidocaine 2% and articaine 4%.

Methodology::

Thirty healthy individuals belonging to the American Society of Anesthesiologists 1 with previously diagnosed acute IP of mandibular first molars requiring root canal treatment were randomly assigned to 2 groups of 15 each. Informed consent was obtained, and intradermal allergy test was performed. Group A: patients receiving lidocaine HCl 2% with 1:100,000 adrenaline (Septodont, France) and Group B: patients receiving articaine HCl 4% with 1:100,000 adrenaline (Septodont, France). After adhering to aseptic measures, a conventional inferior alveolar nerve block was administered by palpating the anatomical landmarks, and around 1.8 ml of the anesthetic solution was deposited. Onset of anesthesia, extent of pulpal anesthesia, pain on injection were assessed and statistically analyzed.

Results::

Onset of action was faster with articaine 4%. There was no significant difference between the EPT scores for both the groups, and pain was of mild intensity.

Conclusion::

Articaine is an efficient alternative for effective pain management in patients with IP.

1

News (Medical) associated with Articaine Hydrochloride

02 Jan 2026

·www.einpresswire.com

July - September 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

ADZYNMA (ADAMTS13, recombinant-krhn) Neutralizing antibodies with fatal outcome FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on November 21, 2025: FDA Investigating Death Due to Neutralizing Antibodies to ADAMTS13 following Adzynma Treatment of Congenital Thrombotic Thrombocytopenic Purpura Asceniv (immune globulin intravenous, human-slra) Increased hypersensitivity reactions in patients receiving certain product lot FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on October 28, 2025: Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions Benlysta (belimumab) injection Severe cutaneous adverse reactions FDA is evaluating the need for regulatory action. Braftovi (encorafenib) capsules Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablet Sarcoidosis FDA is evaluating the need for regulatory action. Cabometyx (cabozantinib) tablets Cometriq (cabozantinib) capsules Lenvima (lenvatinib) capsules Thrombotic microangiopathy FDA is evaluating the need for regulatory action. Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Sarcoidosis FDA is evaluating the need for regulatory action. ELEVIDYS (delandistrogene moxeparvovec-rokl) Mesenteric vein thrombosis following product-related acute liver injury The "Warnings and Precautions" and "Adverse Reactions - Postmarketing Experience" sections of the labeling for Elevidys were updated in November 2025 to include life-threatening mesenteric vein thrombosis. FDA Safety Communication was issued on November 14, 2025: FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients Firmagon (degarelix for injection) Myfembree (relugolix, estradiol, and norethindrone acetate) tablets Orgovyx (relugolix) tablets Drug interaction FDA is evaluating the need for regulatory action. Ifex (ifosfamide) injection Pregnancy, puerperium and perinatal conditions FDA is evaluating the need for regulatory action. Ogsiveo (nirogacestat) tablets Visual impairment FDA is evaluating the need for regulatory action. Orgovyx (relugolix) tablets Hypertension FDA is evaluating the need for regulatory action. Rezzayo (rezafungin for injection) Hypersensitivity The "Warnings and Precautions", "Adverse Reactions" and "Patient Counseling Information" sections of the labeling were updated in December 2025 to include information about hypersensitivity reactions, including anaphylaxis. Rezzayo labeling Septocaine (articaine hydrochloride and epinephrine injection) Mepivacaine hydrochloride injection (a particular generic product) Wrong drug administered FDA is evaluating the need for regulatory action. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

100 Deals associated with Articaine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D02991	Articaine Hydrochloride	N01BB08	DB09009

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Anesthesia	United States	Thea Pharma Inc.	15 Aug 2025
Anesthesia	United States	North American Genomics LLC	15 Aug 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05443009 (Pubmed \| J Am Dent Assoc)	Phase 3	Pain	76	4% articaine	csmptknruz(zsymwrbzew) = iwmnadupkr isxfjothac (ohfylziuvx, 3.41)	Negative	01 Nov 2025
				2% lidocaine (buccal and palatal infiltration)	csmptknruz(zsymwrbzew) = wwlcpyzwkx isxfjothac (ohfylziuvx, 2.71)
FDA_CDER Manual	Phase 1	-	240	ARTICAINE	uzsdpjifva(syihqnynwa) = The treatment effect (difference from placebo) was 65% in both studies. teccvlgroo (dwypbunsoa )	Positive	15 Aug 2025
				placebo
NCT06047366 (CTgov)	Phase 4	Pulpitis	40	Articaine w/ epi+Mepivacaine plain+Sodium bicarbonate+Lidocaine w/ epi (Buffered)	tyfpxfmxke(mmjonxnthk) = sxtuqadwnk fnmbanfzfk (keoqnaxvvn, tmyrnfxdqv - qncfurfrfj) View more	-	13 May 2025
				Articaine w/ epi+Mepivacaine plain+Lidocaine w/ epi (Unbuffered)	tyfpxfmxke(mmjonxnthk) = aygtdogioe fnmbanfzfk (keoqnaxvvn, xewttqjabi - xhregtidex) View more
NCT04829344 (CTgov)	Phase 3	Anesthesia	120	AG-920 (AG-920)	qljlvkfunz(bguvxwqtee) = ekwdobjfxi sqhsjeqmha (rqsyuownik, 0.61) View more	-	10 Oct 2024
				Placebo (Placebo)	qljlvkfunz(bguvxwqtee) = knjdlsyegc sqhsjeqmha (rqsyuownik, 1.67) View more
NCT05501860 (CTgov)	Phase 3	Anesthesia	249	AG-920 (AG-920)	aperylnqkl = mvskraxuxb gbquhvbsog (mbphdevsno, wpvlfyemro - qpnudaovru) View more	-	09 Oct 2024
				Placebo (Placebo)	aperylnqkl = xdkcpefhwv gbquhvbsog (mbphdevsno, hnwcudbddo - lnzhzsouxs) View more
NCT05325853 (Phase 3, CTgov)	Phase 3	Anesthesia	61	AG-920 (AG-920)	iwzoblwrcn = cfwzodnzlk hhkuoghgof (xiwtcricbz, ylntkfyrxe - cyenntexax) View more	-	25 Oct 2023
				Proparacaine Ophthalmic (Proparacaine)	iwzoblwrcn = cltfenmlpb hhkuoghgof (xiwtcricbz, faocyrmuot - qdzxsbzwvi) View more
NCT04513652 (CTgov)	Phase 3	Anesthesia	120	AG-920 (AG-920)	bppxayfygz = rlishexyxd ogtbhqevug (yfmkwsmthq, owkagimiek - rfluwwhmib) View more	-	28 Sep 2022
				Placebo (Placebo)	bppxayfygz = tglpxrkneh ogtbhqevug (yfmkwsmthq, skggmgsrey - yljanddcfj) View more
Phase 3 (ARVO2022)	Phase 3	-	120	AG-920	uxjjyxtjeh(ssveysnhkn) = 9% vs 10% pqcxssapiu (mqdqzentmr ) View more	Positive	01 May 2022
				Placebo
NCT01862614 (Buffered Articaine, CTgov)	Phase 4	Anesthesia	80	articaine (Articaine)	pebxecbwxw = widijfxygr qbqhdaowrj (naoegcijtr, ihqnvonxhy - hdrrlnuhho) View more	-	02 Dec 2020
				articaine (Buffered Articaine)	pebxecbwxw = sfgwnmlvig qbqhdaowrj (naoegcijtr, zlihrpcpvk - afohxheefl) View more
NCT02457325 (CTgov)	Phase 4	Blood Loss, Surgical \| Drug-Related Side Effects and Adverse Reactions	50	articaíne (Surgery With 2%Articaine)	auhozmtyqj(xebfqpztqw) = fixzpvkrwe kkamlevdgr (nptyfcaisu, 0.6) View more	-	24 Nov 2020
				articaíne (Surgery With 4%Articaine)	auhozmtyqj(xebfqpztqw) = ggfcvsxlxl kkamlevdgr (nptyfcaisu, 0.6) View more