Developer
Naurex, Inc.
Northwestern University spin-out that discovered rapastinel (GLYX-13) and apimostinel; acquired by Allergan in August 2015 ($560M upfront).
Pipeline (1)
- Major depressive disorderDiscontinuedDiscontinued
Deals & partnerships
- RapastinelLed by Allergan plc
- Aug 31, 2015AcquisitionAllergan completes acquisition of Naurex, gaining rapastinel (GLYX-13) and NRX-1074Allergan completed its all-cash acquisition of Naurex, Inc. ($560M upfront net of cash, announced 2015-07-26, plus R&D- and sales-milestone payments), acquiring lead asset rapastinel (GLYX-13) — then Phase 3-ready in adjunctive MDD — and the follow-on NRX-1074 (apimostinel). Naurex's discovery platform was spun out to shareholders as Aptinyx prior to closing.
Catalysts · 0 upcoming · 4 reported
Recently reported
- 2019-03-06missed
RapastinelforMajor depressive disorderTopline data
RAP-MD-01 pivotal adjunctive Phase 3: rapastinel did not differentiate from placebo on the primary endpoint (MADRS change at Week 3) or key secondary endpoints
- 2019-03-06missed
RapastinelforMajor depressive disorderInterim analysis
RAP-MD-04 adjunctive relapse-prevention Phase 3: interim analysis indicated primary and key secondary endpoints would not be met
- 2019-03-06missed
RapastinelforMajor depressive disorderTopline data
RAP-MD-02 pivotal adjunctive Phase 3: rapastinel did not differentiate from placebo on primary or key secondary endpoints
- 2019-03-06missed
RapastinelforMajor depressive disorderTopline data
RAP-MD-03 pivotal adjunctive Phase 3: rapastinel did not differentiate from placebo on primary or key secondary endpoints
Recent activity
- Jul 11, 2019Phase changeRapastinel·Major depressive disorderDiscontinuedProgram-wide stop. Allergan issued no dedicated discontinuation press release; the stop is documented on ClinicalTrials.gov, where every remaining study was terminated with whyStopped 'Business decision to stop the program': RAP-MD-20 (suicidality, 2019-06-21), RAP-MD-99 (open-label extension, 2019-07-03), RAP-MD-32 (acute monotherapy, 2019-07-08), RAP-MD-30 and RAP-MD-33 (monotherapy acute + relapse prevention, 2019-07-11), and RAP-MD-31 withdrawn before enrollment. 2019-07-11 is the latest termination date (upper bound of the wind-down).source ↗
- Mar 6, 2019ReadoutRapastinel·Major depressive disordermissedRAP-MD-01 pivotal adjunctive Phase 3: rapastinel did not differentiate from placebo on the primary endpoint (MADRS change at Week 3) or key secondary endpointssource ↗
- Mar 6, 2019ReadoutRapastinel·Major depressive disordermissedRAP-MD-04 adjunctive relapse-prevention Phase 3: interim analysis indicated primary and key secondary endpoints would not be metsource ↗
- Mar 6, 2019ReadoutRapastinel·Major depressive disordermissedRAP-MD-02 pivotal adjunctive Phase 3: rapastinel did not differentiate from placebo on primary or key secondary endpointssource ↗
- Mar 6, 2019ReadoutRapastinel·Major depressive disordermissedRAP-MD-03 pivotal adjunctive Phase 3: rapastinel did not differentiate from placebo on primary or key secondary endpointssource ↗
- Oct 15, 2016Phase changeRapastinel·Major depressive disorderPhase 3First pivotal adjunctive Phase 3 study RAP-MD-01 (NCT02932943) started, ten months after FDA Breakthrough Therapy designation (announced 2016-01-29, which described rapastinel as 'Phase III ready'). RAP-MD-02, RAP-MD-03 and the relapse-prevention study RAP-MD-04 all started within the following month.source ↗
- May 1, 2011Phase changeRapastinel·Major depressive disorderPhase 2Phase 2 single-IV-dose proof-of-concept GLYX13-C201 (NCT01234558) started in MDD patients with inadequate response to antidepressants (registry month precision: May 2011). Published as Preskorn et al., J Psychiatr Pract 2015 — rapid antidepressant effect within 24 hours at 5 and 10 mg/kg without psychotomimetic effects. The repeated-dose Phase 2b GLYX13-C-202 (NCT01684163, n=369) followed from November 2012.source ↗
- Nov 1, 2009Phase changeRapastinel·Major depressive disorderPhase 1First-in-human single-ascending-dose study GLYX13-C-101 (NCT01014650) started (registry month precision: November 2009; day is an anchor).source ↗
Competitive landscape
Other companies developing against Naurex, Inc.'s targets or indications.
- Boehringer Ingelheim2 compoundsGluN2BMajor depressive disorder
- Neurocrine Biosciences, Inc.2 compoundsGluN2BMajor depressive disorder
- Syndeio Biosciences, Inc.2 compoundsGluN2BMajor depressive disorder
- Alto Neuroscience, Inc.2 compoundsMajor depressive disorder
- Autobahn Therapeutics, Inc.1 compoundMajor depressive disorder
- Axsome Therapeutics, Inc.1 compoundMajor depressive disorder
- Beckley Psytech Limited1 compoundMajor depressive disorder
- Biohaven Ltd.1 compoundMajor depressive disorder
- Cerevel Therapeutics Holdings, Inc.1 compoundMajor depressive disorder
- COMPASS Pathways plc1 compoundMajor depressive disorder
- CSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.1 compoundMajor depressive disorder
- Definium Therapeutics, Inc.1 compoundMajor depressive disorder