ASY202 – inhaled DHE development program

ASY202 is an investigational oral inhalation drug-device combination product containing dihydroergotamine mesylate (DHE) as a dry powder formulation delivered via a novel multidose dry powder inhaler (DPI).

ASY202 is not approved by any health authority for commercialization.

ASY202 is being developed for the acute treatment of migraine, with or without aura, in adults.

Phase 1 trials in healthy adults showed that inhaled ASY202 achieved rapid systemic absorption, with a median time to maximum plasma concentration (Tmax) < 10 minutes.1

Following successful completion of Phase 1 trials in healthy volunteers, Aspeya is currently conducting:

  • A randomized, double–blind, placebo–controlled crossover trial in adults with migraine, designed to evaluate the efficacy, safety and tolerability of a single dose of ASY202 for the acute treatment of migraine.

  • A clinical trial in adults with asthma, designed to evaluate pulmonary safety, tolerability and pharmacokinetics following a single dose of ASY202.

These trials are intended to provide additional data on respiratory safety, clinical pharmacology, and treatment response.

¹Goyal P, Teichert A, Murgasova R, et al. First-in-human study to evaluate pharmacokinetics, safety and tolerability of a novel in-development dihydroergotamine mesylate inhalation powder delivered via a multidose dry powder inhaler. Headache. 2025;65 (Suppl 1):P–321. Abstract presented at: American Headache Society 67th Annual Scientific Meeting; June 19–22, 2025; Minneapolis, Minnesota

Potential for ASY202

ASY202 aims to address important patient needs in the acute treatment of migraine²:

  1. Rapid onset of action for fast relief of migraine pain and associated symptoms

  2. Sustained efficacy for long-lasting relief with low levels of symptom recurrence

  3. Effectiveness when taken at any point during a migraine attack, including in cases of nausea and/or vomiting

  4. Improved patient quality of life and rapid return to functioning

For acute treatment, speed of drug delivery is critical. Inhaled administration enables rapid absorption into the systemic circulation, reaching therapeutic plasma concentrations within minutes, and has the potential to offer rapid onset of action.2-7

The development of ASY202 aims to combine the established strengths of DHE with the advantages of inhaled delivery, to create a new, simple-to-administer, acute treatment option to address important unmet needs for people with migraine.

2.Silberstein SD, et al. Headache. 2020 Jan;60(1):40-57
3.Patton JS & Byron PR. Nat Rev Drug Disc. 2007;6:67-74
4.McCarthy SD, et al. J Pers Med. 2020;10(2):37
5.Borghardt JM, et al. Can Respir J. 2018:2732017
6.Abdou M. Ther Deliv. 2019;10:609-611
7.Labiris NR, et al. Br J Clin Pharmacol. 2003;56(6):588-599

DHE is a well-established and recommended acute treatment for migraine, with proven efficacy across a range of clinical settings, including in people with long-lasting or refractory migraine attacks. DHE has also been associated with lower rates of medication overuse headache compared with some other acute therapies.8,9

DHE exhibits a broad neurogenic mode of action through binding to serotonergic, dopaminergic, and adrenergic neurotransmitter receptors, known to mediate migraine activity, including inhibition of trigeminal neuron activation and CGRP release. 2, 10-12

This broad receptor-binding profile may underpin the wide therapeutic effects of DHE across multiple types of migraine.

2.Silberstein SD, et al. Headache. 2020 Jan;60(1):40-57.
8.Ailani, J et al. American Headache Society Consensus Statement. Headache. 2021;61:1021–1039
9.Shrewsbury, SB. DHE – past, present, and future: a narrative review, Pain Management, DOI: 10.1080/17581869.2026.2644524
10.Tepper SJ, et al. Headache. 2024;7: 1-11
11.McConnachie L, et al. Front Neurol 2023; 14: 1282846.
12.Tfelt-Hansen PC. Cephalalgia 2013; 33: 1122–1131

Burden of migraine

Migraine is a common, disabling primary headache disorder that is characterized by recurring attacks of moderate or severe headache, often accompanied by photophobia, phonophobia, nausea, and other neurological symptoms.13

In the United States, migraine affects 39 million people and remains a serious cause of disability, with more than 90% of people unable to work or function normally during their migraine attacks.14

Migraine disproportionately affects women: three times as many adult women as men have migraine attacks.14

Healthcare and lost productivity costs associated with migraine are estimated to be as high as $36 billion annually in the U.S. 14

74% of people report dissatisfaction with their current acute treatment.15

Up to 40% of people do not get adequate relief from their initial acute treatment.16

30-42% of people who experience nausea and vomiting as part of their migraine symptoms reported that these issues interfere with their ability to take oral migraine medications.17

13.International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211.
14.Migraine Facts. Migraine Research Foundation. Available at https://migraineresearchfoundation.org/about-migraine/migraine-facts. Accessed 20/03/2026.
15.Lipton RB, et al. Headache. 2019 Sep;59(8):1310-1323
16.Lombard L, et al. J Headache and Pain 2020; 21-41.
17.Silberstein, SD. Headache 1995;35:387-396.

ASY202 is an investigational product and not approved by any health authority for commercialization in any territory

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