What Apnimed does

Apnimed is a late-stage clinical pharmaceutical company founded in 2017 and headquartered in Cambridge, Massachusetts, dedicated to developing oral pharmacologic therapies for obstructive sleep apnea (OSA) and related sleep-related breathing disorders. The company's lead product candidate, AD109, is a first-in-class fixed-dose oral combination of aroxybutynin (a novel anti-muscarinic) and atomoxetine (a selective norepinephrine reuptake inhibitor) designed to be taken once daily at bedtime. Unlike existing mechanical interventions such as CPAP, AD109 targets the underlying neuromuscular dysfunction of OSA by improving upper airway muscle tone during sleep, with the goal of maintaining airway patency. The drug has completed two Phase 3 trials (SynAIRgy and LunAIRo) enrolling over 1,300 participants, achieving statistically significant reductions in the apnea-hypopnea index of 55.6% and 46.8% respectively, and an NDA has been submitted to the FDA with a PDUFA target action date expected in Q1 2027.

The company has no current commercial revenue and operates as a pre-launch organization funded by venture capital and a recent $150 million debt facility from HealthCare Royalty Partners. Apnimed has assembled a senior leadership team with deep pharmaceutical commercialization experience — including a CEO (Kevin Lind) who previously led Longboard Pharmaceuticals through its acquisition by Lundbeck for $2.6 billion, and a Chief Commercial Officer who led the Nurtec ODT launch at Biohaven prior to its $11.6 billion acquisition by Pfizer. The firm is building a traditional US pharmaceutical go-to-market infrastructure including field-based Medical Science Liaisons, medical affairs, and commercial analytics functions, targeting an addressable market of 80+ million US adults and approximately 1 billion people worldwide suffering from OSA. In March 2026, Apnimed divested its 50% stake in the Shionogi-Apnimed Sleep Science joint venture for $100 million upfront plus a $50 million milestone, refocusing the company exclusively on its wholly-owned AD109 program ahead of the expected commercial launch.

Name

Apnimed

Legal name

Apnimed, Inc.

Website

https://apnimed.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

51–100 employees

Short description

Apnimed is a Cambridge, MA-based late-stage clinical pharmaceutical company developing AD109, a first-in-class once-daily oral combination therapy for obstructive sleep apnea, with an NDA submitted to the FDA and a PDUFA target date in Q1 2027.

Ownership category

akta.pro rank

Product category

Sleep Apnea Therapeutics

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Sleep Apnea Therapy Devices (CPAP/APAP/BiPAP/ASV) (HLAHAGAA)

akta.pro secondary industries

Sleep, Stress & Mood Support (HLAIADAG), Sleep Medicine Clinic (HLAKANAB)

Keywords

• Obstructive sleep apnea therapy
• Oral pharmacologic treatment
• Sleep-related breathing disease
• Neuromuscular modulator drug
• Clinical-stage pharmaceutical

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations, Supply Chain

Revenue model

1. Pharmaceutical product sales: Once AD109 receives FDA approval, Apnimed plans to generate revenue through the sale of prescription pharmaceutical products. The company is preparing for US commercial launch with a field-based medical affairs team and commercial infrastructure.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Apnimed is a clinical-stage pharmaceutical company developing novel oral pharmacologic therapies for obstructive sleep apnea (OSA) and related sleep-related breathing diseases. Its lead product candidate AD109 is a first-in-class fixed-dose combination of aroxybutynin (a novel antimuscarinic) and atomoxetine (a selective norepinephrine reuptake inhibitor) administered as a once-daily bedtime pill. The drug targets the underlying neuromuscular dysfunction in OSA to improve upper airway muscle activity and maintain airway patency during sleep, representing what the company positions as a potential first oral pharmacological treatment for OSA.

Product overview

Apnimed is a late-stage clinical pharmaceutical company developing novel oral therapies for sleep-related breathing diseases. The company's primary focus is AD109, an investigational oral pill for obstructive sleep apnea (OSA) combining aroxybutynin and atomoxetine. Apnimed has completed two Phase 3 clinical trials (SynAIRgy and LunAIRo) and has submitted its New Drug Application to the FDA, with a potential PDUFA target action date expected in Q1 2027.

Differentiator

Problem solved

Functional benefit

Products and services

• AD109 AD109 is an investigational, first-in-class, fixed-dose oral combination of aroxybutynin (a novel antimuscarinic) and atomoxetine (a selective norepinephrine reuptake inhibitor). It is designed to improve oxygenation during sleep by targeting the neuromuscular root cause of obstructive sleep apnea, administered as a once-daily pill taken at bedtime for adults with mild, moderate, or severe OSA.

Quantifiable outcome

• 55.6% reduction in AHI (apnea-hypopnea index) from baseline at 26 weeks in SynAIRgy trial
• +5 more outcomes

Named customers4 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Six partnerships are on record, tiered major and minor.

• Shionogi & Co. LtdmajorStrategic or Co-development Partner · 24 March 2026Strategic monetization of Shionogi-Apnimed Sleep Science (SASS) joint venture where Shionogi acquired Apnimed's 50% ownership stake. Apnimed received $100 million upfront and a $50 million development milestone payment tied to SASS-002 (sulthiame), plus tiered royalties on future commercial sales. This allows Apnimed to focus on its wholly-owned OSA program AD109.
• Alliance of Sleep Apnea Partners (ASAP)minorGTM or Marketing PartnerPatient advocacy partnership promoting and advocating for screening, diagnosis, treatment, and management of optimal health for those who suffer from sleep apnea.
• American Academy of Sleep Medicine (AASM)minorGTM or Marketing PartnerMedical association partnership advancing sleep care and enhancing sleep health through advocacy, accreditation, membership, standards, and education.
• American Sleep Apnea Association (ASAA)minorGTM or Marketing PartnerPatient advocacy partnership advocating for people with sleep apnea and providing comprehensive educational resources on sleep apnea and treatment options.
• National Sleep Foundation (NSF)minorGTM or Marketing PartnerPatient advocacy partnership dedicated to improving health and well-being through sleep education and advocacy.
• Project SleepminorGTM or Marketing PartnerPatient advocacy partnership dedicated to educating the public about sleep health, sleep equity, and sleep disorders through campaigns, events, and programs including the Sleep Apnea Squad educational series.

Scale indicators9 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• ResMed: Global leader in CPAP and other OSA treatment devices; the dominant incumbent in obstructive sleep apnea therapy that Apnimed's AD109 oral pill would directly compete against by offering an alternative to PAP therapy.
• Koninklijke Philips (Philips Respironics): Major CPAP and sleep-respiratory device manufacturer through its Respironics business, and Apnimed's CMO John Cronin was formerly Philips Respironics' Chief Medical Officer. A primary entrenched competitor in OSA treatment that AD109 would seek to displace.
• Fisher & Paykel Healthcare: Major CPAP and nasal-interface manufacturer for OSA therapy; a broad incumbent in sleep apnea treatment whose device-based standard of care AD109 would seek to disrupt.
• Eisai: Large Japanese pharma with sleep medicine franchise including Dayvigo (lemborexant) for insomnia; comparable as a broader pharma incumbent operating in the sleep medicine prescriber space.
• Takeda Pharmaceutical: Global pharma with historical sleep/neurology franchises; comparable as a broad incumbent that has commercialized sleep-disorder therapies and competes for prescriber attention in sleep medicine.

Direct peers

• Inspire Medical Systems: Developer of an FDA-approved implantable hypoglossal nerve stimulation system for OSA, directly competing with AD109 as an alternative to CPAP for patients who fail or refuse PAP therapy.
• Shionogi & Co. Japanese pharma company that now fully owns the SASS joint venture and is developing sulthiame, an oral carbonic anhydrase inhibitor for OSA; a direct competitor in oral OSA pharmacotherapy and Apnimed's former JV partner.

Emerging players

• Jazz Pharmaceuticals: Specialty pharma focused on sleep and neurological disorders with franchises in narcolepsy (Xywav, Sunosi); comparable as a sleep-disorder-focused commercial-stage pharma peer targeting similar prescriber channels.
• Avadel Pharmaceuticals: Sleep-disorder pharma with Lumryz (once-at-bedtime sodium oxybate) for narcolepsy; comparable as a recent commercial-stage sleep pharma peer navigating payer access and prescriber adoption in sleep medicine.
• Nyxoah: Developer of the Genio hypoglossal nerve stimulation system for OSA, an alternative-to-CPAP therapy that competes for the same patient population AD109 is targeting.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/apnimed
• LinkedInlinkedin.com/company/apnimed

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries1 record

Funding overview

Funding rounds9 records

Investors8 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 Apnimed