MTX-101 · Phase 2b-ready

A once-daily tablet for the migraine patients CGRP therapy leaves behind

MTX-101 is a sublingual tablet that works outside the CGRP pathway. It is repurposed from an approved medicine and has an FDA-agreed Phase 2b design in chronic migraine. Manistee is seeking an acquirer or development partner.

Stage
Phase 2b-ready, FDA-agreed design
Indication
Chronic migraine prevention
Format
Once-daily sublingual tablet
Regulatory path
Potential 505(b)(2)
Intellectual property
Issued method-of-use patent

Migraine prevention has one dominant mechanism, and it doesn't work for everyone

Every branded migraine preventive approved since 2018 targets CGRP. Patients who don't respond, or who stop because of injections and infusions, have few places to go.

~3.5M

Americans live with chronic migraine, 15 or more headache days a month. Only about 500,000 are treated.

~1 in 3

CGRP-treated patients never reach a 50% reduction in migraine days, even when they take their medicine.

<30%

of patients are still taking an oral preventive after six months.

Gloved hand pipetting into sample vials at a laboratory bench

The only oral preventive in development outside CGRP

Lundbeck's PACAP antibody, bocunebart, reported positive Phase 2b data in June 2026. It is given by infusion or injection. MTX-101 would be the oral alternative outside CGRP.

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  • A different mechanismTargets a different receptor and modulates the effects of both CGRP and PACAP.
  • A known safety heritageRepurposed from an approved ophthalmic medicine with a characterized systemic profile.
  • A defined pathFDA-agreed Phase 2b design in chronic migraine, with a US launch targeted for 2033.

A team that has built and sold companies, advised by the field's leading migraine researchers

Meet the team

Robert Bratzler, PhD

Co-founder and COO. Helped build four healthcare companies from inception to NASDAQ IPO, including Sepracor.

Mahan Chehrenama, DO

CMO. Neurologist and headache specialist; previously at Amgen, Revance and Avanir.

Marcelo Bigal, MD, PhD

Advisor. As CMO and CSO of Teva, led development of the migraine antibody Ajovy.

Richard Lipton, MD

Advisor. Directs the Montefiore Headache Center; past president of the American Headache Society.

Evaluating MTX-101?

Clinical data, mechanism detail and the development plan are available to qualified parties under a confidentiality agreement.

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MTX-101 is an investigational product. It has not been approved by the US Food and Drug Administration or any other regulatory authority, and its safety and efficacy have not been established. This site contains forward-looking statements about development plans, timelines and market potential that involve risks and uncertainties; actual results may differ materially.

© 2026 Manistee Therapeutics