Drugs / tasimelteon

Regulatory milestones approvals, filings & regulatory actions · 12 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed circadian rhythm sleep disorder, jet lag type 3 milestones
Rejected (CRL) US (FDA) HETLIOZ circadian rhythm sleep disorder, jet lag type 2026-01-08

“the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form.” vandapharma.com ↗

Rejected (CRL) US (FDA) HETLIOZ circadian rhythm sleep disorder, jet lag type 2019-08-16

“received a complete response letter (CRL) on August 16, 2019 from the FDA related to the supplemental New Drug Application (sNDA) of HETLIOZ ®” vandapharma.com ↗

“records relating to the FDA's denial of Vanda's sNDA for HETLIOZ ® in jet lag disorder.” vandapharma.com ↗

Filed US (FDA) HETLIOZ circadian rhythm sleep disorder, jet lag type 2018-12-20

“FDA has accepted the filing of Vanda's Supplemental New Drug Application for HETLIOZ ® (tasimelteon) for the treatment of jet lag disorder.” vandapharma.com ↗

“Vanda submitted its sNDA in October 2018 for approval to market HETLIOZ ® to treat jet lag disorder.” vandapharma.com ↗

Filed insomnia 2 milestones
Filed US (FDA) HETLIOZ insomnia 2023-11-08

“The sNDA for HETLIOZ ® in insomnia was accepted for filing by the FDA” vandapharma.com ↗

Rejected (CRL) US (FDA) HETLIOZ insomnia —

“received a complete response letter (CRL) from the FDA related to the supplemental New Drug Application (sNDA) for HETLIOZ ® in the treatment of insomnia.” vandapharma.com ↗

Filed non-24-hour sleep-wake syndrome 3 milestones
Filed EU (EMA) HETLIOZ non-24-hour sleep-wake syndrome 2014-06-03

“its Marketing Authorization Application (MAA) for oral HETLIOZ ™ (tasimelteon) capsules has been accepted for evaluation by the European Medicines Agency (EMA)” vandapharma.com ↗

“In June 2014 , the EMA accepted for evaluation Vanda's Marketing Authorization Application for oral HETLIOZ ® capsules for the treatment of Non-24.” vandapharma.com ↗

Filed US (FDA) HETLIOZ non-24-hour sleep-wake syndrome 2013-07-29

“On July 29, 2013 Vanda announced that the U.S. Food and Drug Administration ( FDA ) accepted the filing and granted priority review classification to Vanda's New Drug...” vandapharma.com ↗

“has accepted the filing and granted a priority review classification to Vanda's New Drug Application (NDA) for tasimelteon” vandapharma.com ↗

Filed US (FDA) — non-24-hour sleep-wake syndrome 2013-05-31

“today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for tasimelteon” vandapharma.com ↗

Filed Smith-Magenis syndrome 1 milestone
Filed EU (EMA) HETLIOZ Smith-Magenis syndrome —

“Vanda submitted a Marketing Authorization Application for HETLIOZ ® and a Line Extension Application for HETLIOZ LQ ® to the European Medicines Agency” vandapharma.com ↗

“Vanda's MAA for HETLIOZ ® and HETLIOZ LQ ® for Smith-Magenis Syndrome (SMS) is pending with the EMA.” vandapharma.com ↗

“a Line Extension Application for HETLIOZ LQ ® to the European Medicines Agency” vandapharma.com ↗

Approved Indication not stated 3 milestones
Label expansion US (FDA) HETLIOZ — 2020-12-01 fda.gov ↗
Approved EU (EMA) Hetlioz — 2015-07-03 europa.eu ↗
Approved US (FDA) HETLIOZ — 2014-01-31 fda.gov ↗

Trials 26

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05922995 Sep → Dec 2023 REM sleep behavior disorder Brigham and Women's Hospital Terminated No outcome recorded
Phase 19 trials
Phase 1 NCT06323655 Jul → Aug 2018 — Vanda Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02776215 Oct 2016 → Dec 2017 Smith-Magenis syndrome, autism spectrum disorder, non-24-hour sleep-wake syndrome Vanda Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01637636 Jun → Aug 2012 — Vanda Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01578057 Apr → Jun 2012 — Vanda Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01526746 Feb → Jun 2012 impaired renal function disease Vanda Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01540500 Feb → Mar 2012 — Vanda Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01477619 Nov 2011 → Jan 2012 — Vanda Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01402076 Aug 2011 — Vanda Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01271387 Jan → Aug 2011 — Vanda Pharmaceuticals Completed No outcome recorded
Phase 22 trials · 1 met primary
Phase 2 NCT03291041 Jul 2016 → Nov 2017 circadian rhythm sleep disorder, jet lag type Vanda Pharmaceuticals Completed Met primary
Phase 2 NCT00490945 Jul 2004 → Mar 2005 circadian rhythm sleep disorder Vanda Pharmaceuticals Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT02231008 Sep 2015 → Nov 2018 Smith-Magenis syndrome, circadian rhythm sleep disorder Vanda Pharmaceuticals Completed No outcome recorded
Phase 2/3 NCT01428661 Sep 2011 → Jan 2013 major depressive disorder Vanda Pharmaceuticals Completed No outcome recorded
Phase 311 trials · 4 met primary
Phase 3 NCT06953869 Apr 2025 → Nov 2027 expected insomnia Vanda Pharmaceuticals Recruiting No outcome recorded
Phase 3 NCT06701396 Oct 2024 → Jun 2025 overdue circadian rhythm sleep disorder, delayed sleep phase type Vanda Pharmaceuticals Recruiting No outcome recorded
Phase 3 NCT05361707 Jul 2021 → Jul 2025 autism spectrum disorder, sleep disorder Vanda Pharmaceuticals Unknown No outcome recorded
Phase 3 NCT04652882 Dec 2020 → Sep 2026 circadian rhythm sleep disorder Vanda Pharmaceuticals Completed No outcome recorded
Phase 3 NCT03373201 Oct 2017 → Mar 2018 circadian rhythm sleep disorder, jet lag type Vanda Pharmaceuticals Completed Met primary
Phase 3 NCT01429116 Oct 2011 → Jan 2015 non-24-hour sleep-wake syndrome Vanda Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01430754 Sep 2011 → Dec 2012 non-24-hour sleep-wake syndrome Vanda Pharmaceuticals Completed Met primary
Phase 3 NCT01218789 Oct 2010 → Dec 2024 non-24-hour sleep-wake syndrome Vanda Pharmaceuticals Unknown No outcome recorded
Phase 3 NCT01163032 Aug 2010 → Nov 2012 non-24-hour sleep-wake syndrome Vanda Pharmaceuticals Completed Met primary
Phase 3 NCT00548340 Nov 2007 → Feb 2008 insomnia Vanda Pharmaceuticals Completed No outcome recorded
Phase 41 trial
Phase 4 NCT02130999 May 2014 non-24-hour sleep-wake syndrome Vanda Pharmaceuticals Completed No outcome recorded

News releases announcing trial results or a regulatory action · 33

DateIssuerRelease
2026-09-29 Vanda Pharmaceuticals Results Vanda Pharmaceuticals Announces Positive Phase III Results for HETLIOZ®(tasimelteon) in Delayed Sleep-Wake Phase Disorder vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced positive topline results from its pivotal Phase III study of HETLIOZ ® (tasimelteon) 20 mg in adults with Delayed Sleep-Wake Phase Disorder (DSWPD).
2026-03-03 Vanda Pharmaceuticals Regulatory Vanda Announces FDA Grants Landmark Hearing for HETLIOZ® in Jet Lag Disorder, the First Drug Approval Hearing in Over 40 Years vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has granted the company's request for a formal evidentiary public hearing to review the Center for Drug Evaluation and Research's (CDER) proposal to refuse approval of Vanda's supplemental new drug application (sNDA) for HETLIOZ ® (tasimelteon) in the treatment of jet lag disorder.
2026-01-08 Vanda Pharmaceuticals Regulatory Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder vandapharma.com ↗
the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form.
2025-09-25 Vanda Pharmaceuticals Results Vanda Pharmaceuticals announces the publication in PLOS One of an article titled "Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial" vandapharma.com ↗
Improvements in LPS persisted through the follow-up time points (Nights 22 and 29, p < 0.01).
2025-08-18 Vanda Pharmaceuticals Regulatory In a Major Win for Vanda, a Federal Appeals Court Overturns FDA&#039;s Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder vandapharma.com ↗
In a sweeping win for Vanda, the Court set aside the FDA's action.
2024-03-06 Vanda Pharmaceuticals Regulatory Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia vandapharma.com ↗
Consistent with that notification, the FDA has issued a CRL, indicating that the FDA cannot approve the sNDA in its present form.
2024-02-05 Vanda Pharmaceuticals Regulatory Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia vandapharma.com ↗
No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review.
2022-09-07 Vanda Pharmaceuticals Regulatory Vanda Pharmaceuticals Announces Notice of Opportunity for an FDA Hearing on the sNDA for HETLIOZ® In Jet Lag Disorder vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the notice of opportunity for an FDA hearing on Vanda's Supplemental New Drug Application (sNDA) for HETLIOZ ® (tasimelteon) to treat jet lag disorder.
2020-12-01 Vanda Pharmaceuticals Regulatory FDA Approves HETLIOZ® (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved HETLIOZ ® (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS).
2020-08-03 Vanda Pharmaceuticals Regulatory FDA Accepts and Grants Priority Review of Vanda&#039;s Applications for HETLIOZ® (tasimelteon) in the Treatment of Smith-Magenis Syndrome vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review Vanda's applications for Smith-Magenis Syndrome (SMS).
2019-08-19 Vanda Pharmaceuticals Regulatory Vanda Pharmaceuticals FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder vandapharma.com ↗
In the CRL, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance.
2019-07-22 Vanda Pharmaceuticals Regulatory Vanda Pharmaceuticals FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder vandapharma.com ↗
No deficiencies were disclosed by the FDA in this notification, and the FDA stated that this notification does not reflect a final decision on the information under review.

All press releases naming this drug 49 releases

DateIssuerRelease

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 28 sources stand behind the page.

FieldValueCited text
Known as tasimelteon “Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials.” PMID 19054552 ↗ Dec 2008
24

“VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks” NCT00548340 ↗

NCT06701396 ↗

NCT01429116 ↗

NCT01402076 ↗

NCT01218789 ↗

NCT01430754 ↗

NCT06323655 ↗

NCT04652882 ↗

NCT01163032 ↗

NCT02130999 ↗

Show 14 more sources

Known as BMS-214,778 ChEMBL registry synonym — accepted as the source's own label CHEMBL2103822 ↗
Known as HETLIOZ “Efficacy of Tasimelteon (HETLIOZ®) in the Treatment of Jet Lag Disorder” PMID 32754110 ↗ Jul 2020
Known as Hetlioz lq ChEMBL registry synonym — accepted as the source's own label CHEMBL2103822 ↗
Known as VEC-162 “Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials.” PMID 19054552 ↗ Dec 2008
1

NCT00548340 ↗

Action Activate “the melatonin agonist tasimelteon (VEC-162) for treatment of transient insomnia associated with shifted sleep and wake time.” PMID 19054552 ↗ Dec 2008
Modality Small molecule — CHEMBL2103822 ↗
Route Oral “20 mg taken orally 30 minutes prior to bedtime.” NCT00291187 ↗