Request Demo
Last update 16 May 2025
Dihydroergotamine Mesylate
Last update 16 May 2025
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms 5'-benzyl-12'-hydroxy-2'-methyl-3',6',18-trioxo-9,10-dihydroergotaman, 9,10-dihydro-12'-hydroxy-2'-methyl-5'-(phenylmethyl)ergotoman-3',6',18-trione, 9,10-dihydroergotamine + [24] |
Target |
Action agonists |
Mechanism 5-HT1D receptor agonists(Serotonin 1d (5-HT1d) receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (12 Apr 1946), |
Regulation- |
Login to view timeline
Structure/Sequence
Molecular FormulaC34H41N5O8S |
InChIKeyADYPXRFPBQGGAH-UMYZUSPBSA-N |
CAS Registry6190-39-2 |
Related
22
Clinical Trials associated with Dihydroergotamine MesylateACTRN12623001201662
A Phase 1, Single Center, Open-Label Study to Evaluate the Pharmacokinetics, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Ascending Doses of Dihydroergotamine Mesylate (Zephyr) Inhalation Powder, and Dihydroergotamine Mesylate Intravenous, in Healthy Adult Subjects.
Start Date08 Jan 2024 |
Sponsor / Collaborator- |
NCT06319118
A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.
Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson's disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson's disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed.
Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients.
Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients.
Start Date01 Oct 2023 |
Sponsor / Collaborator |
NCT06035913
Doctor of Medicine, Chief Physician, Associate Professor, Master Supervisor, Administrative Deputy Director of Neurology.
Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's disease, the incidence of population over 60 years old in China is 1.37%, Parkinson's disease is often accompanied by various non-motor symptoms, such as salivation. Salivation can occur at any time in Parkinson's disease, with an incidence of 32% to 74%, often leading to social embarrassment, skin infections, bad breath, aspiration pneumonia, etc. This not only reduces the quality of life of patients, but also increases the burden on caregivers. Salivation can improve symptoms with botulinum toxin injections, medications, and non-drug treatments. Dihydroergot mesylate has been shown to be effective in the treatment of salivation in patients with Parkinson's disease, and this study will further observe the medium- to long-term efficacy of the drug on salivation symptoms.
Start Date01 Sep 2023 |
Sponsor / Collaborator |
100 Clinical Results associated with Dihydroergotamine Mesylate
Login to view more data
100 Translational Medicine associated with Dihydroergotamine Mesylate
Login to view more data
100 Patents (Medical) associated with Dihydroergotamine Mesylate
Login to view more data
3,168
Literatures (Medical) associated with Dihydroergotamine Mesylate01 May 2025·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
Restricted access membrane roll with functionalized silica nanoparticles cross-linked by hydrophilic polymer chains on the surface for the direct extraction of Evodiae Fructus active components from rat plasma
Article
Author: Zhuang, Jiayi ; Li, Lidan ; Zhang, Hongwu ; Zhong, Yue ; Xin, Xiaoyu ; Zhong, Yuhao ; Zhu, Mingfang
Evodiamine and other indole alkaloids are the main active constituents in Evodiae Fructus (EF), which is widely applied in traditional Chinese medicine. Recently, the toxic side effects of EF caused by the alkaloid evodiamine have gradually attracted the attention of researchers. In this regard, the rapid and accurate detection of these alkaloids in biological body fluids has become a challenging task. Therefore, it has become a priority that the rapid and efficient extraction of evodiamine etc. alkaloids from blood sample. In this research, a novel method was proposed to prepare the restricted access (RA) membrane with the hydrophobic functional silica nanoparticles cross-linked on the surface by hydrophilic poly-hydroxyethyl methacrylate (p-HEMA). The poly-HEMA chains played the role of protein exclusion and the functional nanoparticles played the role of hydrophobic adsorbent. The RA membrane was wound into a roll shape and inserted into a 1 mL medical syringe to assemble a portable SPE device, named as SRAMR-SPE, for the direct and simultaneous extraction of evodiamine (EVO), rutecarpine (RUT) and dehydroevodiamine (DHE) in rat plasma after a simple dilution with PBS. The prepared functional nanoparticles and RA membrane were characterized by Fourier transform infrared (FT-IR) spectrometer, transmission electron microscopy (TEM), X-ray photoelectron spectroscopy (XPS) and scanning electron microscope (SEM), respectively. HPLC-UV analysis was used to investigate the extraction performance of SRAMR. An associated SRAMR-SPE-HPLC method was constructed and applied to the detection of real rat plasma after the method validation for the verification of the reliability and applicability of the SRAMR-SPE. The experimental results showed that the RA membrane roll (RAMR) had a good ability to exclude plasma proteins and adsorb analytes with multiple reusability. For 3 consecutive cycles of SRAMR-SPE processes, the extraction recoveries of three components at three concentration levels were determined as follows: DHE 93.1-95.1 %, EVO 88.8-91.6 % and RUT 93.6-95.6 %, and the absolute recoveries of the entire SRAMR-SPE-HPLC-UV method were separately as follows: DHE 90.3-92.3 %, EVO 86.2-90.9 %, RUT 91.8-96.4 %. The linear ranges were detected as follows: 0.0600-6.00 μg mL-1 (DHE), 0.105-5.65 μg mL-1 (EVO) and 0.0632-6.32 μg mL-1 (RUT).
01 Mar 2025·Neurotherapeutics
Dehydroervatamine as a promising novel TREM2 agonist, attenuates neuroinflammation
Article
Author: Li, Lin ; Yang, Binrui ; Hua, Zhou ; Chen, Liang ; Xu, Nan ; Tang, Benqin ; Mao, Xiaowen ; He, Yulin ; Du, Jun ; Tang, Mingsui ; Lee, Simon Ming-Yuen ; Song, Bing
Microglia play a dual role in neuroinflammatory disorders that affect millions of people worldwide. These specialized cells are responsible for the critical clearance of debris and toxic proteins through endocytosis. However, activated microglia can secrete pro-inflammatory mediators, potentially exacerbating neuroinflammation and harming adjacent neurons. TREM2, a cell surface receptor expressed by microglia, is implicated in the modulation of neuroinflammatory responses. In this study, we investigated if and how Dehydroervatamine (DHE), a natural alkaloid, reduced the inflammatory phenotype of microglia and suppressed neuroinflammation. Our findings revealed that DHE was directly bound to and activated TREM2. Moreover, DHE effectively suppressed the production of pro-inflammatory cytokines, restored mitochondrial function, and inhibited NLRP3 inflammasome activation via activating the TREM2/DAP12 signaling pathway in LPS-stimulated BV2 microglial cells. Notably, silencing TREM2 abolished the suppression effect of DHE on the neuroinflammatory response, mitochondrial dysfunction, and NF-κB/NLRP3 pathways in vitro. Additionally, DHE pretreatment exhibited remarkable neuroprotective effects, as evidenced by increased neuronal viability and reduced apoptotic cell numbers in SH-SY5Y neuroblastoma cells co-cultured with LPS-stimulated BV2 microglia. Furthermore, in our zebrafish model, DHE pretreatment effectively alleviated behavioral impairments, reduced neutrophil aggregation, and suppressed neuroinflammation in the brain by regulating TREM2/NF-κB/NLRP3 pathways after intraventricular LPS injection. These findings provide novel insights into the potent protective effects of DHE as a promising novel TREM2 agonist against LPS-induced neuroinflammation, revealing its potential therapeutic role in the treatment of central nervous system diseases associated with neuroinflammation.
01 Mar 2025·CNS & Neurological Disorders-Drug Targets
Recent Development of Zolmitriptan Formulation in Migraine Therapy: Production, Metabolism and Pharmaceutical Aspects
Review
Author: Alsufyani, Mohammed Omair ; Rashid, Mohammad ; Al-Jarallah, Abdulrahman Mohammed ; Alqethami, Mohammed Ghanim ; Alhothali, Khadijah Oudah R. ; Dewangan, Rikeshwer Prasad ; Husain, Asif ; Hakme, Mohammed Japer Mohammed ; Bano, Farha ; Aba Alkhayl, Faris F.
The triptans class of pharmaceuticals, which was created to treat acute migraine, is
made up of indole-containing drugs that bind to a subset (1B/1D) of 5-hydroxytryptamine
receptors and are agonists of serotonin receptors. At the moment, naratriptan, eletriptan,
zolmitriptan, rizatriptan, almotriptan, and frovatriptan are the seven types of triptans available on
the market. Among these are the FDA-approved triptans, Zolmitriptan and Sumatriptan, which
are selective serotonin (5-hydroxytryptamine) agonists. Zolmitriptan, a synthetic tryptamine
derivative and a well-known member of the triptan family, is available as an orally disintegrating
tablet, nasal spray, and tablet. There are melt formulations of rizatriptan and zolmitriptan
available on the market that are easier to use and absorb, comparable to regular pills. Recently,
the FDA approved zolmitriptan, a medication with tolerability comparable to sumatriptan.
Whereas zolmitriptan is only available as an oral melt or tablet, sumatriptan is available as a
nasal spray, oral preparation, or self-injectable kit. The only known antimigraine drugs that were
widely utilized before the triptan period were ergotamine and dihydroergotamine. However,
zolmitriptan binds to plasma proteins only 25% of the time because of significant first-pass
degradation. Researchers have looked into fresh ideas for solving this issue and innovations to
overcome its pharmacokinetic difficulties. This article emphasizes the role of zolmitriptan in the
treatment of migraines, highlighting its pharmacological properties, production, metabolism, and
structural features.
168
News (Medical) associated with Dihydroergotamine Mesylate15 May 2025
Brekiya® becomes the first and only DHE autoinjector that allows patients to self-administer the same medication used in hospitals in a ready-to-use form Product will be available for appropriate patients in the second half of 2025 BRIDGEWATER, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.1,2 Brekiya autoinjector provides patients with the potential for sustained* pain relief† in a convenient, self-administered form.1,3,4 It contains the same medication (DHE) used in hospitals, now in a ready-to-use device.1,5 Brekiya autoinjector does not require refrigeration, assembly, or priming of the device.1 Patients can deliver one dose subcutaneously into the middle of the thigh.1 This may be beneficial for patients who respond inadequately to oral therapies due to lack of efficacy, experience nausea or vomiting during attacks, have gastroparesis, or delay dosing until too late into the attack.1,5,6
“We are thrilled to offer the first and only ready-to-use autoinjector for patients suffering from acute migraine and cluster headaches. Physicians are familiar with DHE, which is an effective and well-established therapy that provides sustained relief for headaches. Our single-dose autoinjector represents an innovative therapeutic option for patients that allows for quick self-administration of the medication during these painful attacks without visiting the emergency room,” said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty. DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. DHE can be used at any point during a migraine attack, and may protect patients from headache recurrence.1,3,4 Approximately 39 million Americans are living with migraine7, and up to one million with cluster headache.8 Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all emergency room visits in the United States.9 There are limited treatment options available for cluster headache, and Brekiya autoinjector represents a new treatment option for this underserved population.2 Do not take Brekiya autoinjector with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. See additional Important Safety Information below. IndicationBrekiya autoinjector is a prescription medicine used for the acute treatment of migraine with or without aura and acute cluster headaches in adults. Brekiya autoinjector is not used to prevent migraine or used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura). It is not known if Brekiya autoinjector is safe and effective in children. IMPORTANT SAFETY INFORMATIONSerious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Brekiya autoinjector) with strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together.
Do not use Brekiya autoinjector if you: are taking medicines known as strong CYP3A4 inhibitors, such as: ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, ketoconazole, or itraconazole.have heart problems or a history of heart problems, or uncontrolled high blood pressure.have narrowing of blood vessels in your legs, arms, stomach, or kidneys (peripheral vascular disease).have sepsis, had vascular surgery, severe liver or kidney problems.are allergic to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in Brekiya autoinjector.have taken any of the following medicines in the last 24 hours: sumatriptan, frovatriptan, ergotamine or ergotamine-type medicines, almotriptan, naratriptan, zolmitriptan, eletriptan, or rizatriptanhave taken any medicines that constrict your blood vessels or raise your blood pressure. Before you take Brekiya autoinjector, tell your healthcare provider about all your medical conditions, including if you: have high blood pressure, liver problems, or kidney problems.have risk factors for heart disease, such as: high blood pressure, high cholesterol levels, smoke, are overweight, diabetes, family history of heart disease.are pregnant or plan to become pregnant. Brekiya autoinjector may cause preterm labor. Brekiya autoinjector should be avoided during pregnancy. Talk to your healthcare provider right away if you are pregnant or want to become pregnant.are breastfeeding or plan to breastfeed. Brekiya autoinjector may reduce breast milk supply and pass into your breast milk. Brekiya autoinjector may be harmful to your baby. Do not breastfeed your baby while taking Brekiya autoinjector and for 3 days after you use Brekiya autoinjector. Talk with your healthcare provider about the best way to feed your baby if you take Brekiya autoinjector. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: sumatriptan, ergot-type medicine, saquinavir, nefazodone, fluconazole, grapefruit juice, zileuton, nicotine, propranolol or other medicines that can lower your heart rate, any medicines that can increase your blood pressure, selective serotonin reuptake inhibitors. These are not all of the medicines that could affect how Brekiya autoinjector works. Your healthcare provider can tell you if it is safe to take Brekiya autoinjector with other medicines. How should I use Brekiya autoinjector? Certain people should take their first dose of Brekiya autoinjector in their healthcare provider’s office or in another medical setting.Brekiya autoinjector is for injection under the skin (subcutaneous) only.Use Brekiya autoinjector exactly as your healthcare provider tells you to use it.Each autoinjector contains one dose (1 mg).If your headache comes back after the first complete dose, you may give yourself up to 2 more doses as needed. Wait at least one hour between doses.Do not inject more than 3 doses (3 mg) of Brekiya autoinjector in a 24-hour period or 6 doses (6 mg) in a 1-week (7 day) period. What are the possible side effects of Brekiya autoinjector?Brekiya autoinjector can cause serious side effects, including:
Heart attack and other heart problems. Heart problems may lead to death. Stop taking Brekiya autoinjector and get emergency medical help right away if you have any symptoms of a heart attack, such as: numbness or tingling in your fingers and toes, muscle pain or cramps in your arms and legs, weakness in your legs, temporary speeding or slowing of your heart rate, or swelling or itching. Brekiya autoinjector is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. Stroke. Stop using Brekiya autoinjector and get emergency medical help right away if you have any of the symptoms of a stroke.Changes in color or sensation in your fingers and toes (Raynaud’s syndrome).Stomach and intestinal problems.Increased blood pressure.Medicine overuse headache. Some people who use too much Brekiya autoinjector may make their headaches worse. If your headaches get worse, your healthcare provider may decide to stop your treatment with Brekiya autoinjector.Preterm labor.Tissue changes (fibrotic complications). Inflammation and fiber-like tissue that is not normal (fibrosis) can occur around the lungs and stomach. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Brekiya autoinjector. Call your healthcare provider for medical advice about side effects. How should I store Brekiya autoinjector? Store at room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze.Protect Brekiya autoinjector from light.Keep Brekiya autoinjector in the original pack until ready to use. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use at Brekiya.com. *Sustained represents a duration of approximately 24-72 hours2,3†Cluster headache results reported using IV administration.4 References:
Brekiya [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2025.Data on File. Amneal Pharmaceuticals LLC.Winner P, Ricalde O, Le Force B, Saper J, Margul B. Arch Neurol. 1996;53(2):180-184.Mather PJ, Silberstein SD, Schulman EA, Hopkins MM. Headache. 1991;31(8):525-532.Silberstein SD, Shrewsbury SB, Hoekman J. Headache. 2020;60(1):40-57. doi:10.1111/head.13700Aurora SK, Papapetropoulos S, Kori SH, Kedar A, Abell TL. Cephalalgia. 2013;33(6):408-415.https://migraineresearchfoundation.org/about-migraine/migraine-facts/https://americanmigrainefoundation.org/resource-library/cluster-headache-2/Phelan, M, Thompson NR, Zubair A et al. Emergency department utilization among patients who receive outpatient specialty care for headache: A retrospective cohort study analysis. Headache. 2023;63:472–483. Brekiya is a registered trademark of Amneal Pharmaceuticals LLC. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn. Cautionary Statement on Forward-Looking StatementsCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Investor Contact Anthony DiMeoVP, Investor Relations anthony.dimeo@amneal.comMedia ContactBrandon SkopSr. Director, Corporate CommunicationsBrandon.skop@amneal.com PP-PRS-DHE-US-0001 05/2025
Drug Approval
01 May 2025
The FDA approved a new nasal spray for migraines that was developed by Satsuma Pharmaceuticals.
Previously called STS101, the company
said
Wednesday that the drug’s brand name is Atzumi and is indicated for acute migraine with or without aura. There was no immediate information on pricing.
The FDA previously
rejected
the drug in January 2024, citing issues with the product’s manufacturing process. The company resubmitted its application in November.
The FDA’s decision arrived on time — the PDUFA date was Wednesday. The timing of new drug approvals is increasingly being scrutinized in light of the widespread staffing cuts at the FDA under Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr.
Stealth BioTherapeutics on Tuesday
reported a delay
in the FDA’s decision for its Barth syndrome drug, and a person familiar with the situation said it wasn’t related to safety, efficacy or manufacturing.
Atzumi combines dihydroergotamine (DHE) with a dry-powder formulation administered through nasal delivery. The compound constricts the brain’s blood vessels and inhibits the release of pro-inflammatory substances.
DHE medications, which have been around since the 1940s, are typically administered through injections, and nasal forms of the drug are viewed as less effective. The approval was based on a Phase 1 pharmacokinetic study and an open-label Phase 3 trial. A separate Phase 3 study
missed
its co-primary endpoints in 2022.
Atzumi is Satsuma’s only pipeline candidate, and the company has been focused on winning FDA approval for the medication since it spun out of Shin Nippon Biomedical Laboratories in 2017. Shin Nippon reacquired Satsuma in 2023.
Phase 3Drug ApprovalAccelerated Approval
01 May 2025
Atzumi™ (dihydroergotamine(DHE)) nasal powder is the first and only DHE nasal powder for the acute treatment of migraine with or without aura in adults in an easy-to-use, easy-to-carry device.
Atzumi is the first and only product utilizing the SMART (Simple MucoAdhesive Release Technology) platform which combines a proprietary advanced powder and device technology to simplify delivery of DHE.
In clinical studies, Atzumi administration provided rapid and sustained DHE concentrations with low variability.
DURHAM, N.C., April 30, 2025 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other debilitating conditions, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced that the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi™(dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi was previously known as STS101.
Migraine is a neurological disorder that is thought to be the result of temporary changes in the chemicals, nerves and blood vessels in the brain, with symptoms that are often incapacitating. According to the American Migraine Foundation, approximately 40 million Americans live with migraine. It is the second leading cause of disability worldwide in terms of time lost to disability and most common cause of disability among young women.
"The approval of Atzumi is a milestone to celebrate, providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on SNBL's novel intranasal drug delivery platform technology," said Dr. Ryoichi Nagata, President and CEO of Satsuma. "We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems."
"DHE plays a unique clinical role in the acute treatment of migraine, providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack. The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages", said Dr. Stewart J. Tepper, M.D., Vice President of the New England Institute for Neurology and Headache in Stamford, Connecticut.
About Atzumi
Atzumi is a proprietary drug device product incorporating both Satsuma's advanced nasal powder formulation of dihydroergotamine (DHE) administered via its unique nasal delivery device. The product is designed to provide patients an easy-to-use and easy-to-carry treatment option.
The FDA approval for Atzumi is based on two clinical studies (Phase 1 PK trial and ASCEND Phase 3 open-label, long-term safety trial), which demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine.
About Dihydroergotamine (DHE)
Since its approval in 1946, DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE.
IMPORTANT SAFETY INFORMATION
WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of Atzumi with strong CYP3A4 inhibitors is contraindicated.
Indication
Atzumi is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Atzumi is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura.
Contraindications
Atzumi is not recommended in patients with:
Concomitant use of strong CYP3A4 inhibitors
Ischemic heart disease or coronary artery vasospasm
Uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment
Hypersensitivity to ergot alkaloids
Concomitant use of other 5-HT₁ agonists or ergotamine-containing or ergot-type medication within 24 hours
Concomitant use of peripheral and central vasoconstrictors
Warnings and Precautions
Atzumi may cause:
Cardiac events: Cardiac events in patients with risk factors of coronary artery diseases: Consider administration of the first dose of Atzumi under medical supervision (including the use of an electrocardiogram)
Cerebrovascular events: Cerebrovascular events (eg, cerebral hemorrhage, subarachnoid hemorrhage, and stroke) have been reported, particularly with dihydroergotamine mesylate injection
Vasospasm/elevated blood pressure: Dihydroergotamine may cause vasospasm or elevation in blood pressure
Medication overuse headache: Detoxification may be necessary
Preterm labor: Advise pregnant women of the risk
Fibrotic complications: Rare cases have been reported following prolonged daily use of dihydroergotamine mesylate. Administration of Atzumi should not exceed the dosing guidelines or be used for chronic daily administration
Local irritation: Local irritation has been reported following administration of Atzumi
Most Common Adverse Reactions
Most common adverse reactions (incidence >1%) were rhinitis, nausea, altered sense of taste, application site reaction, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.
Use in Special Populations
Pregnancy: Available data from published literature indicate an increased risk of preterm delivery with Atzumi us during pregnancy.
Lactation: Patients should not breastfeed during treatment with Atzumi and for 3 days after the last dose.
Please see the Atzumi Full Prescribing Information, including Boxed Warning and Medication Guide.
The risk information provided here is not comprehensive. The FDA-approved product labeling can be found at . You can also call 1-888-273-2480 for additional information.
About Satsuma Pharmaceuticals
Satsuma Pharmaceuticals Inc., a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), is a late-stage biopharmaceutical company headquartered in Research Triangle Park, North Carolina. Since its inception in 2016, Satsuma has focused on combining great science, cutting-edge technology and proven drug therapies to create improved therapeutic products that address the significant unmet needs of patients. Satsuma's team has extensive experience successfully developing, manufacturing and commercializing pharmaceutical products within both large and small companies, and we have particular expertise in the area of drug-device combination products delivered via inhalation. For further information, please visit .
About SNBL
Shin Nippon Biomedical Laboratories, Ltd. ("SNBL") (TSE:2395) is a listed nonclinical contract research organization (CRO) that was founded in Kagoshima, Japan, in 1957. Based on its corporate philosophy of "Committed to the environment, life, and people", and with a proven track record of accomplishment as the oldest and most established Japanese nonclinical CRO, SNBL is proud to offer a comprehensive portfolio of services and solutions for drug discovery and development for pharmaceutical companies, biotech ventures, universities, and research institutions both in Japan and overseas. The SNBL's Translational Research business engages in drug discovery, with the focus on business development and out-licensing of its proprietary intranasal drug delivery technologies and intranasal devices. For further information, please visit .
Cautionary Note on Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Satsuma's future business, future position and results of operations, including estimates, forecasts, targets and plans for Satsuma. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding SNBL's business, including uncertainty of commercial success for new and existing products; claims or concerns regarding the safety or efficacy of product candidates; general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; the impact of health crises such as the coronavirus pandemic on Satsuma and its clients and suppliers, including foreign governments in countries in which Satsuma operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Satsuma's operations and the timing of any such divestment(s); and other factors identified in SNBL's most recent securities report ("Yuka Shoken Houkokusho") and SNBL's other reports filed with the Financial Services Agency, available on SNBL's website at: or at . SNBL does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or related stock exchange rule. Past performance is not an indicator of future results and the results or statements of SNBL in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of SNBL's future results.
Medical Information
This press release contains information about product candidates that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
Inquiries:
Satsuma Pharmaceuticals, Inc.
E-mail: [email protected]
Website:
SOURCE Satsuma Pharmaceuticals, Inc.
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
440k+
Newsrooms &
Influencers
9k+
Digital Media
Outlets
270k+
Journalists
Opted In
GET STARTED
Clinical ResultPhase 3Drug ApprovalNDA
100 Deals associated with Dihydroergotamine Mesylate
Login to view more data
External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D02211 | Dihydroergotamine Mesylate |
R&D Status
Approved
10 top approved records. to view more data
Login
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Cluster Headache | United States | 12 Apr 1946 | |
| Migraine Disorders | United States | 12 Apr 1946 |
Developing
10 top R&D records. to view more data
Login
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Migraine With Aura | NDA/BLA | United States | 28 Nov 2024 | |
| Acute migraine | NDA/BLA | United States | 18 May 2023 | |
| Migraine Without Aura | Phase 3 | United States | 24 Jun 2019 | |
| Hyperalgesia | Clinical | United States | 01 Dec 2003 | |
| Pain | Preclinical | United States | 01 Apr 2025 |
Login to view more data
Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 3 | 344 | STS101 5.2 mg | clfwunsetf(ygzowhnvma) = ciixkpjnqv gzfkdmotfh (vtiljbrcwq ) View more | Positive | 07 Oct 2024 | ||
NCT05351086 (PRNewswire) Manual  | Phase 1 | - | PUR3100 with intravenous (IV) placebo | gulldruuec(joqyaauqvo) = zxffvylrsm qgeuozinrm (fmzlehoeog ) View more | Positive | 15 May 2024 | |
Phase 3 | 1,591 | Placebo | zphghwwweu = rpofeywsvx rwtiqrwvmo (axsdenxszi, gwrfhgpjqg - mpyxcuxszn) View more | - | 24 Jul 2023 | ||
Phase 3 | 482 | fnlaxoprcb = wstyakmaxo aewnvryprq (wihheobxgt, gwnikqmpzg - mgoozpegrh) View more | - | 03 Jul 2023 | |||
Phase 3 | 1,201 | (STS101 Low Dose) | kjyzllyyzp = zoilpjfrxb gahciywhpe (wtsfnwbyjw, oazbjfcawt - jfgstiiovj) View more | - | 29 Jun 2023 | ||
(STS101 High Dose) | kjyzllyyzp = jpnhycufeq gahciywhpe (wtsfnwbyjw, ipsvlajlhc - ofogtgdtrr) View more | ||||||
Phase 3 | 344 | xfpvlcbnvm(vkvqkwhsnf) = 99.5% of subjects had no nasal bleeding/ulceration at 12 months invoiiyahv (buhipanikj ) View more | - | 25 Apr 2023 | |||
Phase 3 | 1,591 | pchaxyqkoa(lwdgxfdzsz): P-Value = 0.1661 View more | Negative | 14 Nov 2022 | |||
Placebo | |||||||
Phase 3 | 482 | bctzcwncox(igcugstzui) = no treatment-related serious adverse events were reported uxnnlxfuyu (afnqozreli ) | Positive | 20 Sep 2022 | |||
Phase 3 | 354 | ltjxiavgng(yfhgxocqwu) = vjvivqebxp kgaqfgjoyw (nruqeaqryq ) View more | - | 03 May 2022 | |||
Phase 3 | 354 | xmfvevhmjo(dgfwieyefe) = dvnssetqes pblmcpymwb (ctojfefeww ) View more | - | 03 May 2022 |
Login to view more data
Translational Medicine
Boost your research with our translational medicine data.
login
or
Deal
Boost your decision using our deal data.
login
or
Core Patent
Boost your research with our Core Patent data.
login
or
Clinical Trial
Identify the latest clinical trials across global registries.
login
or
Approval
Accelerate your research with the latest regulatory approval information.
login
or
Regulation
Understand key drug designations in just a few clicks with Synapse.
login
or
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free