ALKS Alkermes

ALKS 7290 · NCT07755410 registry update

countries: {'total_sites': 19, 'us_sites': 19} → {'total_sites': 28, 'us_sites': 28}

Alkermes to Present Alixorexton and LUMRYZ Data at Sleep Europe 2026

Alkermes will present new data from the Vibrance-1 Phase 2 study and long-term extension of alixorexton in narcolepsy type 1 and 2, plus detailed Phase 3 REVITALYZ results for LUMRYZ in idiopathic hypersomnia, at the Sleep Europe 2026 conference on October 21-23, 2026.

alixorexton · NCT06767683 registry update

primary_completion: 2028-06 → 2030-06; completion: 2028-06 → 2030-06; enrollment: 256 → 786; countries: {'total_sites': 49, 'us_sites': 33} → {'total_sites': 50, 'us_sites': 34}

ALKS 7290 · NCT07755410 registry update

countries: {'total_sites': 2, 'us_sites': 2} → {'total_sites': 19, 'us_sites': 19}

alixorexton · NCT07540897 registry update

countries: {'total_sites': 17, 'us_sites': 14} → {'total_sites': 20, 'us_sites': 15}

alixorexton · NCT06843590 registry update

status: RECRUITING → ACTIVE_NOT_RECRUITING

Alkermes Reports Positive Phase 1b Topline for ALKS 7290 in Adult ADHD

ALKS 7290, an oral orexin-2 receptor agonist, showed dose-dependent, clinically meaningful improvements on AISRS and CGI-S scales versus baseline in adults with ADHD after 14 days. The asset was generally well tolerated with no serious adverse events. This provides clinical proof-of-concept and supports the ongoing Phase 2 study.

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

FDA granted orphan drug designation to alixorexton for idiopathic hypersomnia; European Commission granted ODD for narcolepsy. These designations add development incentives and market-exclusivity potential if approved.

Alkermes: LUMRYZ meets all endpoints in Phase 3 IH study

REVITALYZ Phase 3 trial showed statistically significant improvements in ESS, PGI-C and IHSS versus placebo. Alkermes plans to file an sNDA for idiopathic hypersomnia by end of 2026. Marketing of LUMRYZ for IH is restricted until March 1, 2028 per prior settlement.

Alkermes initiates Phase 3 Brilliance program for alixorexton in narcolepsy

Alkermes has started three 12-week Phase 3 studies (Brilliance NT1 Studies 302/304 and Brilliance NT2 Study 303) to evaluate alixorexton versus placebo in adults with narcolepsy type 1 and type 2. The primary endpoint is change in mean sleep latency on the maintenance of wakefulness test (MWT). The program follows positive Phase 2 results and includes once-daily and split-dose regimens.