Last update 30 Jun 2024

Sumatriptan Succinate

Last update 30 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummarySumatriptan is a small molecule drug and developed by GSK. Its first approved in 1996 in the USA. Sumatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine and cluster headaches through agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release. Some scientists believe that sumatriptan may act as an agonist at the 5-HT1B/1D receptors, triggering a response and activating the receptors, which ultimately translates into a reprieve from the misery of migraine and cluster headaches.

Drug Type

Small molecule drug

Synonyms

(3-[2-(dimethylamino)ethyl]-1H-indol-5-yl)-N-methylmethanesulfonamide, 1-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]-N-methyl-methanesulfonamide, 3-(2-(dimethylamino)ethyl)-N-methyl-1H-indole-5-methanesulfonamide

+ [34]

Target

5-HT1B receptor x 5-HT1D receptor

Mechanism

5-HT1B receptor agonists(Serotonin 1b (5-HT1b) receptor agonists), 5-HT1D receptor agonists(Serotonin 1d (5-HT1d) receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther DiseasesDigestive System Disorders

Active Indication

Cluster HeadacheMigraine DisordersGastrointestinal dysfunction

Inactive Indication

Acute migraineHeadacheInflammatory Bowel Diseases+ [3]

Originator Organization

GSK Plc

Active Organization

Currax Pharmaceuticals LLCStartup

GSK Plc

Desitin Arzneimittel GmbH

+ [3]

Inactive Organization

Sandoz, Inc.

ENDO Medical, Inc.StartupEndo Ventures Ltd.

+ [5]

Drug Highest PhaseApproved

First Approval Date

(05 Apr 1991),

Cluster HeadacheMigraine Disorders

Regulation-

Structure

Molecular FormulaC18H27N3O6S

InChIKeyPORMUFZNYQJOEI-UHFFFAOYSA-N

CAS Registry103628-47-3

101

Clinical Trials associated with Sumatriptan Succinate

NCT06217094 / Not yet recruitingPhase 1IIT

Phase I Study of NP-101 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Undergoing Y-90 Treatment

Surgical resection and liver transplantation are the primary curative treatments for hepatocellular carcinoma (HCC). However, many patients are ineligible for these treatments due to advanced disease, social factors, or limited availability of liver donors. Therefore, for patients with unresectable HCC, locoregional therapies like transarterial radioembolization (TARE with Y90) are considered the next best non-operative option, especially when the cancer remains confined to the liver. Despite the use of these liver-directed therapies, relapse rates and mortality remain high, underscoring the need for new predictive biomarkers and therapeutic targets, including immune modulation.
The rationale behind NP-101 (TQ formula) stems from its immune modulatory properties as a potent drug derived from a natural substance, black seed or Nigella Sativa. Previous studies have demonstrated its immune modulation and anti-cancer effects, showing promise in preclinical models of HCC. In a randomized phase 2 study conducted in Covid patients, NP-101 exhibited safety and significantly increased T effector cells (CD4+ and CD8+ T lymphocytes), resulting in accelerated recovery. The immune modulation effect of NP-101, observed in the Covid study, and its potential to enhance CD4+ and CD8+ T effector lymphocytes can potentially modify the immune microenvironment and improve outcomes in locally advanced HCC patients undergoing Y90 treatment.
This study will investigate the safety, efficacy and maximum tolerated dose of NP-101 in patients with unresectable hepatocellular carcinoma.
The dosing scheme for NP-101 in this study will follow a Bayesian Optimal Interval design. Based on the target dose-limiting toxicity (DLT) rate of 30% and assuming a 3+3 design, three subjects will be sequentially enrolled at each of the 3 dose levels (beginning with 3g) until at least one DLT occurs.
If no DLTs occur, dosing will be escalated to the next dose level for the next three enrolled subjects. At either of the two dose levels, if 1 DLT occurs, three more subjects will be enrolled at that dose level. If no DLTs occur in these subjects, three more subjects will be enrolled at the next highest dose level. Dosing escalation will be stopped if two or more total DLTs occur at any dose level. The maximum tolerated dose (MTD) will be one dose level below the dose level at which two or more DLTs occurred.

Start Date01 Aug 2024

Sponsor / Collaborator

University of Florida

[+1]

ChiCTR2400083722 / SuspendedEarly Phase 1

Clinical efficacy of sumatriptan combined with chemotherapy in the treatment of advanced colorectal cancer and its impact on the quality of patient survival Clinical research protocols

Start Date01 May 2024

Sponsor / Collaborator

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

NCT05654298 / CompletedNot ApplicableIIT

Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response After a Histamine Skin Prick as Well as After the Topical Application of Cinnamaldehyde and Capsaicin

The involvement of calcitonin gene-related peptide (CGRP) in the cinnamaldehyde-induced dermal blood flow increase and in the mechanism of action of triptans will be investigated. The capsaicin-induced dermal blood flow will be incorporated as a positive control; histamine skin pricks as a negative control. Changes in dermal blood flow will be measured with laser speckle contrast imaging.

Start Date15 Mar 2022

Sponsor / Collaborator

Katholieke Universiteit Leuven

100 Clinical Results associated with Sumatriptan Succinate

100 Translational Medicine associated with Sumatriptan Succinate

100 Patents (Medical) associated with Sumatriptan Succinate

2,905

Literatures (Medical) associated with Sumatriptan Succinate

01 Feb 2024·British journal of pharmacology

PACAP‐38 related modulation of the cranial parasympathetic projection: A novel mechanism and therapeutic target in severe primary headache

Article

Author: Goadsby, Peter J ; Akerman, Simon ; Romero-Reyes, Marcela

Abstract:

Background and Purpose:

Little is known of how cranial autonomic symptoms (CAS) in cluster headache and migraine may contribute to their severe headache phenotype. This strong association suggests the involvement of the cranial parasympathetic efferent pathway. To investigate its contribution, we studied the role of pituitary adenylate cyclase activating polypeptide‐38 (PACAP‐38), a potent sensory and parasympathetic neuropeptide, in modulating pre‐ and post‐ganglionic cranial parasympathetic projection neurons, and their influence on headache‐related trigeminal‐autonomic responses.

Experimental Approach:

Using PACAP‐38 and PACAP‐38 responsive receptor antagonists, electrophysiological, behavioural and facial neurovascular‐blood flow was measured in rats to probe trigeminal‐ and parasympathetic‐neuronal, periorbital thresholds and cranial‐autonomic outcomes, as they relate to primary headaches.

Key Results:

Sumatriptan attenuated the development of PACAP‐38 mediated activation and sensitization of trigeminocervical neurons and related periorbital allodynia. PACAP‐38 also caused activation and enhanced responses of dural‐responsive pre‐ganglionic pontine‐superior salivatory parasympathetic neurons. Further, the PACAP‐38 responsive receptor antagonists dissected a role of VPAC1 and PAC1 receptors in attenuating cranial‐autonomic and trigeminal‐neuronal responses to activation of the cranial parasympathetic projection, which requires post‐ganglionic parasympathetic neurotransmission.

Conclusion and Implications:

Given the prevailing view that sumatriptan acts to some degree via a peripheral mechanism, our data support that PACAP‐38 mediated receptor activation modulates headache‐related cranial‐autonomic and trigeminovascular responses via peripheral and central components of the cranial parasympathetic projection. This provides a mechanistic rationale for the association of CAS with more severe headache phenotypes in cluster headache and migraine, and supports the cranial parasympathetic projection as a potential novel locus for treatment by selectively targeting PACAP‐38 or PACAP‐38 responsive VPAC1/PAC1 receptors.

01 Feb 2024·Journal of hazardous materials

Oxidation of amine-based pharmaceuticals with unactivated peroxymonosulfate: Kinetics, mechanisms, and elimination efficiency of NDMA formation

Article

Author: Zeng, Zhu ; Fu, Junhao ; Gao, Yuan ; Zhou, Yang ; Zhang, Zhong ; Ma, Jinxing ; Han, Bin ; Jiang, Jin

Amine-based pharmaceuticals are a significant class of N-nitrosodimethylamine (NDMA) precursors. This study investigated the use of unactivated peroxymonosulfate (PMS) to control amine-based pharmaceuticals and their NDMA formation potential. Kinetic analysis and product identification revealed that sumatriptan and doxylamine primarily underwent reactions at their tertiary amine group, while ranitidine and nizatidine had both tertiary amine and thioether group as reaction sites. The NDMA formation from sumatriptan and doxylamine during post-chloramination was significantly reduced with the abatement of the parent contaminants, while the formation of NDMA remained high even if full abatement of ranitidine and nizatidine was achieved. Product formation kinetics and reference standard tests revealed the great contribution of transformation products to NDMA formation. Ranitidine could be oxidized to sulfoxide-type product ranitidine-SO and N-oxide type product ranitidine-NO. Ranitidine-SO exhibited a high NDMA yield comparable to that of ranitidine (>90%), while ranitidine-NO showed a low NDMA yield (2%). With further oxidation of ranitidine-SO at the tertiary amine group, NDMA formation was reduced by more than 90%. The underlying mechanism for the importance of the tertiary amine group in NDMA formation was demonstrated by quantum chemical calculation. These findings underscore the potential of PMS pre-oxidation on NDMA control.

01 Jan 2024·Handbook of clinical neurology

Review

Author: Kamourieh, Salwa ; Anderson, Jane M ; Rozen, Todd

Status migrainosus is one of the recognized complications of migraine with or without aura, defined as a persistent debilitating migraine attack lasting for more than 72h with little reprieve, leading to functional disability. The individual impact of status migrainosus and the substantial healthcare burden are highlighted. Current case series which inform our understanding of this condition are examined with two groups emergent, those with classic status migrainosus and those with episodic status migrainosus. The question as to whether status migrainosus is a distinct biological state beyond the established migraine pathophysiology is examined. With the underlying pathophysiology not fully understood, attention is turned to therapeutic considerations and the available evidence informing practice. A practical approach to treatment of status migrainosus is presented. Given the severity and need for emergency care, options detailed are in line with recommendations for acute migraine care: with a staged approach initially combining subcutaneous sumatriptan with parenteral options including dopamine receptor antagonists, nonsteroidal anti-inflammatories and acetaminophen. The place of combination treatment with parenteral magnesium sulfate, dihydroergotamine, antiepileptics, corticosteroids, and anesthetic agents is outlined. With a paucity of high-quality evidence to consolidate current clinical approaches, consideration of future therapies and research questions is raised.

110

News (Medical) associated with Sumatriptan Succinate

28 Jun 2024

·www.globenewswire.com

Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering

CHATHAM, N.J., June 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 2,833,900 shares of its common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569 per pre-funded warrant. The warrants have an exercise price of $0.001 per share and became exercisable upon issuance. The gross proceeds of the offering are $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness. Dawson James Securities, Inc. acted as the sole placement agent for the offering. Lowenstein Sandler, New York, NY, represented the Company in connection with the offering, and ArentFox Schiff LLP, Washington, DC, represented the placement agent. This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering was made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering were filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state 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 or jurisdiction. Tonix Pharmaceuticals Holding Corp.*Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. 1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking StatementsCertain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the intended use of proceeds from the public offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor ContactJessica MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182 Peter VozzoICR Westwickepeter.vozzo@westwicke.com(443) 213-0505 Media ContactKatie DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com(978) 360-3151

Phase 3

26 Jun 2024

·www.globenewswire.com

Tonix Pharmaceuticals Announces Proposed Public Offering

CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness. Dawson James Securities, Inc. is the sole placement agent for the offering. This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state 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 or jurisdiction. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. *Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. 1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor Contact Jessica Morris Tonix Pharmaceuticals investor.relations@tonixpharma.com (862) 904-8182 Peter Vozzo ICR Westwicke peter.vozzo@westwicke.com (443) 213-0505 Media Contact Katie Dodge LaVoieHealthScience kdodge@lavoiehealthscience.com (978) 360-3151

Phase 3NDA

26 Jun 2024

·www.globenewswire.com

Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement

CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On June 26, 2024, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a closing bid price at or above $1.00 per share for a minimum of 10 consecutive business days, Tonix’s stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2), and the matter is now closed. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya**, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. *Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. **Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor Contact Jessica MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com (862) 904-8182 Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443) 213-0505 Media Contact Katie DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com(978) 360-3151

Phase 3NDABreakthrough Therapy

100 Deals associated with Sumatriptan Succinate

External Link

KEGG	Wiki	ATC	Drug Bank
D00676	Sumatriptan Succinate	N02CC01	DB00669

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine With Aura	US	Sandoz, Inc.	06 Feb 2009
Migraine With Aura	US	Teva Pharmaceuticals USA, Inc.	06 Feb 2009
Cluster Headache	-	GSK Plc	05 Apr 1991
Migraine Disorders	-	GSK Plc	05 Apr 1991

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Irritable bowel syndrome with diarrhea	Phase 3	CN	Guangxi Xinwei Pharmaceutical Technology Co Ltd.	19 Apr 2018
Acute migraine	Phase 3	US	Currax Pharmaceuticals LLCStartup	02 Nov 2017
Migraine Without Aura	Phase 3	US	Currax Pharmaceuticals LLCStartup	02 Nov 2017
Headache	Phase 3	US	Avanir Pharmaceuticals, Inc.	01 Aug 2012
Gastrointestinal dysfunction	Preclinical	CN	Guangxi Xinwei Pharmaceutical Technology Co Ltd.	30 Jan 2022
Inflammatory Bowel Diseases	Preclinical	CN	Guangxi Xinwei Pharmaceutical Technology Co Ltd.	23 Jun 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03338920 (CTgov)	Phase 3	Acute migraine \| Migraine Without Aura	159	sumatriptan nasal powder (Sumatriptan Nasal Powder)	apurakgnli(badkvaursv) = ynuadmsfis jqdtkvgife (safmjbrjws, alamgjizel - tcafeohcnf) View more	-	24 Jul 2023
				Placebo (Placebo)	apurakgnli(badkvaursv) = vuvmyfnaet jqdtkvgife (safmjbrjws, yqcvggagps - uuahktkwhu) View more
Phase 1 (AAN2023)	Phase 1	-	-	Zavegepant 10mg nasal spray	pvmhoxkcvv(bfnipfbivh) = auvdgxbcet xvghksogte (iaqjnfmmrb, 88.93% - 105.23%) View more	Positive	25 Apr 2023
1976 (AAN2020)	Not Applicable	Migraine Disorders \| Headache Disorders, Secondary	-	Triptan exposed patients	moxifjfrmz(frrwxhiwtz) = nlnkciwura dctvjeftpz (dbiockxpeg, 12.1 - 12.9)	-	14 Apr 2020
AAN2019	Not Applicable	-	18	DFN-02 monodose	pryiunalbn(ewknrmpzzl) = values were similar rdmtzdsfat (khiiuboyfj )	-	09 Apr 2019
				DFN-02 multidose
P4.10-019 (AAN2019)	Not Applicable	Migraine Disorders	-	Oral Triptans	kqlqmnccia(zmrtxekrae) = lhtgpuisnw osdgeqsmam (yxwlwtkmjf ) View more	-	09 Apr 2019
				Nasal Spray Triptans	kqlqmnccia(zmrtxekrae) = hstwbpgbdt osdgeqsmam (yxwlwtkmjf ) View more
AAN2019	Not Applicable	Migraine Disorders	20	3 mg SC sumatriptan	ytxuonfxls(fopsjbmkrq) = ezmubhaicj pyiycagefj (eccqgbmtlk )	Positive	09 Apr 2019
				6 mg SC sumatriptan	ytxuonfxls(fopsjbmkrq) = bavsllmnxs pyiycagefj (eccqgbmtlk )
S59.003 (AAN2019)	Not Applicable	Migraine Disorders	-	New Triptan Users	oypqcztlnu(nkgzraovdl) = ahollgzmbn hglsfkqvjq (zmyqgzilea )	Negative	09 Apr 2019
				No Refill for Initial Triptan	oypqcztlnu(nkgzraovdl) = irarpxnquy hglsfkqvjq (zmyqgzilea )
NCT02569853 (RESTOR, Pubmed)	Phase 3	Migraine Disorders	392	DFN-11 (sumatriptan injection, 3 mg)	uueaxohrmw(ekikktcytm) = 0.9% vs 1.7% cjuuvsnypk (czjvinlisv ) View more	Positive	15 Aug 2018
				Placebo
NCT02569853 (RESTOR, CTgov)	Phase 3	Migraine Disorders	268	DFN-11 (DFN-11)	nrzfgmqyhi(rbckrpdtdm) = alcckzhmbb iogsgxveiq (ilzpumnash, eawzoftvkl - unyrkgfqkq)	-	26 Jul 2018
				Placebo (Placebo)	nrzfgmqyhi(rbckrpdtdm) = ihayoqtneg iogsgxveiq (ilzpumnash, dlnetxncpq - vyujdyjzcv)

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis