Asset profile

alixorexton · Alkermes (ALKS)

Indication: narcolepsy type 1 and type 2
Also known as: ALKS 2680

Company

Alkermes PLC is a fully integrated biotechnology company that applies its proprietary technologies to research, develop, and commercialize pharmaceutical products designed for unmet medical needs in therapeutic areas. The company utilizes several to develop an…

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On the calendar

Oct 2026

~ Oct 2026

ALKSAlkermes

Alkermes to Present Alixorexton and LUMRYZ Data at Sleep Europe 2026

Conference presentationCompany press releaseMonth only

Nov 2026

~ Nov 2026

ALKSAlkermes

alixorexton: Phase 2 trial NCT06843590 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

May 2027

~ May 2027

ALKSAlkermes

alixorexton: Phase 3 trial NCT07502443 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

May 2027

~ May 2027

ALKSAlkermes

alixorexton: Phase 3 trial NCT07455383 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Jun 2027

~ Jun 2027

ALKSAlkermes

alixorexton: Phase 3 trial NCT07540897 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Jun 2030

~ Jun 2030

ALKSAlkermes

alixorexton: Phase 2/Phase 3 trial NCT06767683 expected to finish collecting primary-endpoint data (topline results usually follow)

Rescheduled — was Jun 1, 2028

Trial primary completionClinicalTrials.govMonth only

Timeline

Newest first.

Oct 13, 2026

11:00 AM

ALKSAlkermes

Alkermes to Present Alixorexton and LUMRYZ Data at Sleep Europe 2026

Conference presentationCompany press release

Oct 9, 2026

03:24 PM

ALKSAlkermes

alixorexton · NCT06767683 registry update

Trial registry changeClinicalTrials.gov

Oct 7, 2026

03:20 PM

ALKSAlkermes

alixorexton · NCT07540897 registry update

Trial registry changeClinicalTrials.gov2 updates

Sep 25, 2026

03:22 PM

ALKSAlkermes

alixorexton · NCT06843590 registry update

Trial registry changeClinicalTrials.gov Open record

Jun 15, 2026

11:00 AM

ALKSAlkermes

Alkermes: alixorexton granted ODD in U.S. (IH) and EU (narcolepsy)

FDA designationCompany press release

Apr 1, 2026

11:00 AM

ALKSAlkermes

Alkermes initiates Phase 3 Brilliance program for alixorexton in narcolepsy

Trial registry changeCompany press release

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Oct 13, 2026

Primary endpoint metUnknown

Overall survival significant or trendingUnknown

US / Western patient shareFavourable

190 of 300 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedUnknown

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentUnknown

Related companies

Each relationship is backed by the filing that stated it.

ALKSAlkermesOwner

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT07540897	Phase 3	Recruiting	Jun 1, 2027	150	15 of 20 sites in the United States
NCT06555783	Phase 2	Completed	Nov 11, 2025	93	33 of 47 sites in the United States
NCT07502443	Phase 3	Recruiting	May 1, 2027	176	23 of 44 sites in the United States
NCT06843590	Phase 2	Active, not recruiting	Nov 1, 2026	126	34 of 50 sites in the United States
NCT06358950	Phase 2	Completed	Jun 19, 2025	92	29 of 45 sites in the United States
NCT06767683	Phase 2/3	Recruiting	Jun 1, 2030	786	34 of 50 sites in the United States
NCT07455383	Phase 3	Recruiting	May 1, 2027	150	22 of 44 sites in the United States

More from Alkermes

Other drugs and candidates from the same company tracked in this sector.

ALKS 7290adjunctive treatment of major depressive disorder (MDD)sodium oxybateidiopathic hypersomnia