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Alkermes unveils ADHD data for orexin drug, expanding the class beyond sleep disorders

Alkermes unveils ADHD data for orexin drug, expanding the class beyond sleep disorders

New Capabilities

Following Takeda's first-of-its-kind narcolepsy approval, Alkermes bets orexin agonists can treat ADHD and chronic fatigue

September 21st, 2026: Alkermes presents pioneering ADHD data for orexin agonist

Overview

Updated Sep 21

Alkermes presented its orexin agonist as an ADHD treatment on September 21, the first time the new drug class has moved into a mainstream psychiatric market. The company calls the program a potential 'company changer.'

Takeda's oveporexton became the first approved orexin agonist in late 2025, treating the root cause of narcolepsy type 1. Alkermes, with its own narcolepsy drug in phase 3, has identified 19 neuroscience conditions where the mechanism might work — and ADHD is the largest target.

Orexin is a brain signaling system tied to wakefulness, arousal, attention and fatigue. Alkermes' candidates also target fatigue in multiple sclerosis and Parkinson's disease, schizophrenia symptoms and depression, mapping a trajectory that could rival how GLP-1 drugs expanded from diabetes into obesity and beyond.

Why it matters

Orexin agonists, if they work for ADHD and chronic fatigue, could give millions of patients a non-stimulant alternative and create a new blockbuster drug class.

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Key Indicators

$7.8B
Eli Lilly's maximum payment for orexin biotech Centessa
The deal value signals how much big pharma is paying for orexin agonist assets.
19
Neuroscience applications Alkermes sees for orexin modulation
Ranges from ADHD and fatigue to schizophrenia and depression.
2
Alkermes orexin candidates in phase 1 beyond narcolepsy
ALKS 4510 for fatigue in MS and Parkinson's; ALKS 7290 for ADHD.
3
Markets where Takeda's oveporexton is approved
United States, Japan and China; more submissions underway.

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People Involved

RP
Richard F. Pops
Chief executive officer, Alkermes
Leading Alkermes' orexin platform expansion
BJ
Blair Jackson
Chief operating officer, Alkermes
Leads orexin strategy; identified 19 potential applications

Organizations Involved

Alkermes plc
Alkermes plc
Biopharmaceutical company
Developing orexin agonists across sleep, ADHD and fatigue

Dublin-based Alkermes (Nasdaq: ALKS) develops and markets neuroscience drugs, including treatments for opioid and alcohol dependence, schizophrenia, bipolar disorder and narcolepsy.
Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited
Pharmaceutical company
Markets the first approved orexin agonist

Osaka-based Takeda developed oveporexton (Orzeyful), the first approved orexin receptor 2 agonist, for narcolepsy type 1.
Eli Lilly and Company
Eli Lilly and Company
Pharmaceutical company
Acquiring Centessa's orexin pipeline for up to $7.8B

Indianapolis-based Lilly agreed to pay up to $7.8 billion for Centessa Pharmaceuticals, adding an orexin agonist pipeline to its neuroscience portfolio.

Timeline

December 2025 September 2026

8 events Latest: September 21st, 2026 · 2 months ago
Tap a bar to jump to that date

  1. Alkermes presents pioneering ADHD data for orexin agonist

    Latest Clinical Data

    Alkermes unveils data positioning an orexin agonist as an ADHD treatment, the class's first move beyond sleep disorders. The company frames the program as a potential 'company changer.'

  2. NEJM publishes Takeda's oveporexton phase 3 data

    Publication

    The New England Journal of Medicine publishes results from two phase 3 studies of oveporexton in narcolepsy type 1.

  3. Alkermes and Takeda release rival narcolepsy updates

    Corporate Update

    Both companies present data on their orexin agonists; Alkermes CEO Richard Pops says the class has broader potential in psychiatry and neurology.

  4. Alixorexton sustains nine-month wakefulness gains in long-term study

    Clinical Data

    Interim analysis shows maintained improvements in wakefulness, sleepiness, cognition and fatigue at week 24 across narcolepsy types 1 and 2.

  5. Alixorexton earns orphan designations in US and Europe

    Regulatory

    FDA grants orphan status for idiopathic hypersomnia; European Commission grants it for narcolepsy. Alixorexton already held breakthrough designation for narcolepsy type 1.

  6. Alkermes maps orexin expansion across 19 neuroscience areas

    Strategy

    Chief operating officer Blair Jackson discloses plans to apply orexin modulation to ADHD, fatigue, schizophrenia and depression, beyond narcolepsy.

  7. Lilly agrees to buy Centessa for up to $7.8 billion

    Deal

    The reported acquisition would give Lilly an orexin agonist pipeline — the largest deal yet in the emerging class.

  8. Takeda wins first orexin agonist approval

    Approval

    Regulators in the US, Japan and China approve oveporexton for narcolepsy type 1 — the first drug to treat narcolepsy's underlying orexin deficiency.

Scenarios

1

Alkermes reports positive phase 2 ADHD data for ALKS 7290

Possible Resolves by Q2 2028

Discussed by: Fierce Biotech, MedCity News; Alkermes leadership

If ALKS 7290 shows attention and impulsivity improvements in a phase 2 trial, the orexin class enters mainstream psychiatry — its largest addressable market yet. Non-stimulant ADHD drugs have historically underperformed, but orexin's distinct mechanism (boosting a brain arousal system rather than acting on dopamine like stimulants) could break through where others failed.

2

Takeda and Lilly dominate; Alkermes' ADHD push stalls or is acquired

Possible Resolves by End of 2028

Discussed by: MedCity News (noting Takeda's lead); analysts tracking orexin M&A

Takeda already markets the first approved orexin agonist and Lilly paid up to $7.8 billion for Centessa's pipeline. If Alkermes' ADHD candidate fails or progresses slowly, the company may sell its orexin assets to a larger buyer, or stay a focused narcolepsy and fatigue player while bigger rivals capture the ADHD market.

3

Alkermes' alixorexton wins FDA approval for narcolepsy, anchoring the franchise

Likely Resolves by End of 2028

Discussed by: Alkermes (phase 3 trials underway); follows positive phase 2 data

Phase 3 Brilliance trials in narcolepsy types 1 and 2 are running, with orphan and breakthrough designations already granted. Approval would establish Alkermes as a direct competitor to Takeda in the core market, funding further orexin expansion regardless of ADHD outcomes.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

December 2017 - 2024

GLP-1 agonists: Ozempic to Wegovy (2017-2024)

Novo Nordisk's semaglutide won diabetes approval as Ozempic in 2017, then obesity approval as Wegovy in 2021. The class has since shown benefits in heart and kidney disease, and Novo briefly became Europe's most valuable company as demand outstripped supply.

Then

Semaglutide sales exceeded $14 billion in 2023, and the class became the fastest-growing drug category in history.

Now

A mechanism that started in one metabolic niche became a platform treating millions across multiple conditions — the template for how a single target becomes a therapeutic franchise.

Why this matters now

Orexin agonism is following the same playbook: narcolepsy first, then ADHD and fatigue. The open question is how far the mechanism actually stretches.

December 1998 - 2010

Provigil (modafinil) wakefulness expansion (1998-2010)

Cephalon won narcolepsy approval for modafinil (Provigil) in 1998, expanding later to shift-work sleep disorder and obstructive sleep apnea. It became a blockbuster with heavy off-label use for general fatigue and alertness.

Then

Provigil sales peaked near $1 billion annually before generic competition; Cephalon faced legal scrutiny over off-label promotion.

Now

The wakefulness niche proved commercially viable, but overexpansion drew regulatory attention — a cautionary tale for the orexin class.

Why this matters now

Orexin agonists target the same wakefulness system modafinil engaged more crudely, but with a cleaner mechanism and potential to treat more conditions.

1955 - 1996

The stimulant era in ADHD (1955-1996)

Methylphenidate (Ritalin) launched for ADHD in 1955; mixed amphetamine salts (Adderall) followed in 1996. Stimulants remain the first-line ADHD standard despite abuse potential, side effects and recurring supply shortages.

Then

Stimulants dominate ADHD treatment, with millions of prescriptions and periodic shortages.

Now

A non-stimulant class with comparable efficacy has been a long-sought goal in ADHD — most attempts have struggled to match stimulant potency.

Why this matters now

Orexin agonists offer a mechanistically distinct, non-stimulant path. That is the core reason Alkermes sees ADHD as its biggest expansion target.

Sources

(9)
+3
Fierce Biotech MedCity News Juta MedicalBrief Alkermes plc SEC EDGAR Takeda BioSpace Alkermes plc Fierce Biotech