What Kallyope does

Kallyope is a privately held, late-stage clinical biotechnology company founded in 2015 and headquartered in New York City, applying the science of gut-brain biology to develop therapeutics for migraine and metabolic disorders. Its integrated discovery engine, branded the Klarity™ Platform, combines single-cell transcriptional sequencing, neural circuit mapping via optogenetics and chemogenetics, proprietary human genetics derived from genome-wide association studies, mouse and human enteroid systems, and small-molecule and peptide chemistry capabilities to identify novel drug targets in neural circuits. The pipeline is anchored by elismetrep (K-304), a first-in-class oral TRPM8 antagonist for the acute treatment of migraine that has completed a positive Phase 2b study and is planned to enter Phase 3 in mid-2026, and by K-554, a first-in-class non-incretin peptide candidate for metabolic disease expected to enter Phase 1 in mid-2026.

Kallyope's commercial model today is bifurcated: future prescription pharmaceutical sales through standard wholesale, specialty pharmacy, and physician-prescribing channels post-FDA approval, and current non-dilutive income from licensing milestones and royalties. The September 2024 Novo Nordisk option exercise on an obesity ligand generated an upfront fee and entitles Kallyope to development and sales milestones plus worldwide royalties, while an $8.2 million Bill & Melinda Gates Foundation grant (May 2023) funds a separate environmental enteric dysfunction program. As of the latest disclosures, the company has raised approximately $479 million in total equity funding, including a $236 million Series D in February 2022 co-led by Mubadala Investment Company and The Column Group at a $1.446 billion post-money valuation, and has not yet reported commercial product revenue. The customer base, once products are approved, will be fragmented across migraine patients (one in six Americans) and metabolic/obesity patients (approximately one in three U.S. adults), targeted through traditional physician-led biopharmaceutical commercialization rather than direct-to-consumer channels.

Name

Kallyope

Legal name

Kallyope Inc.

Website

https://kallyope.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

51–100 employees

Short description

Kallyope is a late-stage clinical biotechnology company developing first-in-class gut-brain axis therapeutics, with elismetrep (a TRPM8 antagonist) entering Phase 3 for acute migraine and K-554 advancing into Phase 1 for metabolic disease, supported by the integrated Klarity™ discovery platform and a Novo Nordisk obesity partnership.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

akta.pro primary industry

Target Identification & Validation Platforms (omics-driven, chemoproteomics, genetic validation) (HLAAAIAI)

akta.pro secondary industry

In Vivo Discovery & Translational Models Platforms (humanized models, PK/PD, efficacy) (HLAAAIAK)

Keywords

• Gut-brain therapeutics
• Migraine drug development
• Metabolic disorder medicines
• Neural circuit drug discovery
• Biopharmaceutical pipeline

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical product sales: Kallyope is a late-stage biotechnology company developing novel therapeutics. Once drugs are approved by regulatory authorities (FDA and equivalent), the company will generate revenue through the sale of prescription pharmaceutical products, initially focusing on elismetrep for acute migraine treatment and K-554 for metabolic disease/obesity.
2. Licensing and milestone payments: Kallyope has entered into licensing agreements with partners such as Novo Nordisk, receiving upfront option exercise fees and may receive additional payments for development and sales milestones and royalties on worldwide product sales of licensed products.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Kallyope is a late-stage biotechnology company that discovers and develops novel therapeutics targeting the gut-brain axis. Its lead asset, elismetrep (K-304), is an oral TRPM8 antagonist in Phase 3 development for acute migraine, and its second program, K-554, is a non-incretin peptide for metabolic disorders entering Phase 1. Discovery is enabled by the proprietary Klarity™ Platform, which integrates single-cell sequencing, neural circuit mapping, optogenetics, human genetics, and organoid models to identify novel drug targets in neural circuits.

Product overview

Kallyope is a late-stage biotechnology company developing innovative medicines for migraine and metabolic disorders. The company's portfolio includes two lead clinical programs: Elismetrep (K-304), a first-in-class oral TRPM8 antagonist for acute migraine treatment currently in Phase 2b and advancing toward pivotal studies in mid-2026, and K-554, a first-in-class non-incretin peptide for metabolic disease entering Phase 1 in mid-2026. The Klarity™ Platform serves as the core discovery engine, integrating single-cell sequencing, circuit mapping, optogenetics, human genetics, and organoid technologies to identify novel therapeutic targets in neural circuits. An undisclosed program is partnered with Novo Nordisk for obesity therapeutics.

Differentiator

Problem solved

Functional benefit

Brands

• Klarity™ Platform: An integrated end-to-end technology platform leveraging single-cell transcriptional sequencing, pathway circuit mapping, optogenetics and chemogenetics, proprietary validated human genetics, mouse and human organoids, and small molecules and peptides capabilities for drug discovery targeting neural circuits involved in migraine and metabolism.

Products and services

• Elismetrep (K-304) First-in-class oral antagonist of TRPM8 (Transient Receptor Potential Melastatin 8) being developed for the acute treatment of migraine. It is the only TRPM8 migraine-associated channel blocker in late-stage clinical development, targeting trigeminal sensory neurons via a mechanism distinct from CGRP antagonists and triptans, and has demonstrated efficacy and favorable safety/tolerability across 13 clinical studies with 1,055 people exposed.
• K-554 First-in-class non-incretin peptide therapeutic candidate targeting a novel neural feeding circuit for metabolic disorders including obesity and type 2 diabetes. Distinct from GLP-1 and amylin receptor biology, it is intended to enable monotherapy and combination use with anticipated good tolerability. Entering clinical development in mid-2026.
• Klarity™ Platform Integrated end-to-end discovery platform that combines single-cell transcriptional sequencing, pathway circuit mapping, optogenetics/chemogenetics, proprietary human genetics, mouse and human organoids, and small molecule/peptide capabilities to identify novel therapeutic targets in neural circuits. It is the core discovery engine that generated Kallyope's pipeline including elismetrep and K-554, and underpins the company's partnered discovery work with Novo Nordisk.
• Novo Nordisk Obesity Ligand Program A Kallyope-discovered ligand licensed to Novo Nordisk for therapeutic development, including potential treatment for obesity. Novo Nordisk assumed responsibility for further preclinical and clinical development, manufacturing, and commercialization, with Kallyope retaining milestone and royalty economics.

Quantifiable outcome

• Phase 2b: 20mg dose achieved 19.6% vs 9.1% placebo for 2h pain freedom (OR=2.4, P=0.0344), 38.3% vs 24.2% for freedom from most bothersome symptom (OR=1.9, P=0.0425), 58.8% vs 42.4% for pain relief (OR=1.9, P=0.0293)
• +3 more outcomes

Segments2 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Novo NordiskflagshipStrategic or Co-development Partner · 10 September 2024Novo Nordisk exercised its option to license a Kallyope-identified ligand for therapeutic development including potential treatment for obesity. Under the terms of the research collaboration, Novo Nordisk will assume responsibility for further preclinical and clinical development, manufacturing, and commercialization. Kallyope received an upfront option exercise fee and may receive additional payments for development and sales milestones and royalties on worldwide product sales.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• AbbVie: Acquired Allergan's migraine franchise including Ubrelvy (ubrogepant) for acute migraine and Qulipta (atogepant) for migraine prevention, both CGRP antagonists that compete directly with Kallyope's elismetrep. AbbVie is a much larger pharmaceutical incumbent with a broader diversified portfolio across immunology, oncology, and neuroscience.
• Pfizer: Acquired Biohaven Pharmaceuticals in 2022 and now markets Nurtec ODT (rimegepant), a leading CGRP-targeting migraine therapy for both acute and preventive treatment, directly competing with elismetrep. Pfizer is a global pharmaceutical incumbent with a significantly broader portfolio across multiple therapeutic areas.
• Eli Lilly: Markets Reyvow (lasmiditan), a 5-HT1F receptor agonist for acute migraine, and dominates the metabolic disease market with Mounjaro/Zepbound (tirzepatide) for obesity and type 2 diabetes. Lilly competes with Kallyope in both lead therapeutic areas as a much larger incumbent with significant commercial infrastructure.
• Amgen: Co-markets Aimovig (erenumab) with Novartis, the first-to-market CGRP receptor antibody for migraine prevention. Amgen is a large biotechnology incumbent with a broader portfolio across inflammation, oncology, and cardiovascular disease, competing with Kallyope's migraine program.
• Teva Pharmaceutical Industries: Markets Ajovy (fremanezumab), a CGRP antibody for migraine prevention. Teva is a global pharmaceutical incumbent with a broader portfolio including generics, central nervous system products, and immunology assets, competing in migraine prevention where elismetrep may eventually expand.
• Lundbeck: Markets Vyepti (eptinezumab), an IV-administered CGRP antibody for migraine prevention. Lundbeck is a mid-size pharmaceutical incumbent focused on neuroscience, directly competing with Kallyope in migraine with a focused but well-established commercial presence.

Direct peers

• Viking Therapeutics: Late-stage clinical biotechnology company developing VK2735, a dual GLP-1/GIP receptor agonist in Phase 2/3 for obesity, and VK2809 for metabolic liver disease. Highly comparable to Kallyope's metabolic program given similar company size, clinical stage, and therapeutic focus in obesity and metabolic disorders.
• Altimmune: Clinical-stage biotechnology company developing pemvidutide, a GLP-1/glucagon dual agonist for obesity and metabolic liver disease. Similar company size and stage as Kallyope with overlapping metabolic disease focus and comparable clinical milestones.
• Structure Therapeutics: Clinical-stage biotechnology company developing oral small molecule GLP-1 agonists and other peptide-based therapies for metabolic diseases and pulmonary hypertension. Directly comparable to Kallyope's peptide approach in metabolic disease with similar company size and development stage.
• Axsome Therapeutics: Late-stage CNS-focused biotechnology company with Auvelity (dextromethorphan-bupropion) for major depressive disorder and AXS-07 (MoSEIC meloxicam-rizatriptan) for acute migraine. Comparable size, clinical stage, and CNS drug development focus to Kallyope with similar investor profile and pre-commercial business model.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/kallyope

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds6 records

Investors17 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Kallyope