Developer · JNJ · United States
Johnson & Johnson
Johnson & Johnson (NYSE: JNJ) is an American multinational developer of pharmaceuticals (Innovative Medicine) and medical devices (MedTech). Its Innovative Medicine arm, formerly branded Janssen, develops the company's CNS/neuroscience pipeline.
Pipeline (4)
- Major depressive disorderPhase 3Active
- Alzheimer's diseasePhase 2Active
- Major depressive disorderDiscontinuedDiscontinued
- Alzheimer's diseaseDiscontinuedDiscontinued
Deals & partnerships
- AticaprantLicensor Cerecor Inc.
- JNJ-2056 (ACI-35.030)Licensor AC Immune SA
- Seltorexant (JNJ-42847922)Partner Minerva Neurosciences, Inc.
- Aug 14, 2017AcquisitionJanssen acquires CERC-501 (aticaprant) asset from CerecorJanssen Pharmaceuticals acquired all rights to CERC-501 (the selective kappa-opioid receptor antagonist later designated JNJ-67953964 / aticaprant) from Cerecor for ~$25M upfront (incl. $3.75M escrow) plus up to $20M in regulatory milestones. The molecule originated at Eli Lilly (LY-2456302) and was licensed by Cerecor from Lilly in early 2015 before this divestiture to Janssen.
- Jan 12, 2015Licensing dealJanssen in-licenses anti-Tau active immunotherapy ACI-35 (later JNJ-2056) from AC ImmuneWorldwide exclusive license and research collaboration for AC Immune's anti-Tau therapeutic vaccine ACI-35 (lead candidate ACI-35.030, later renamed JNJ-2056) for Alzheimer's disease. Upfront payment plus development/commercialization milestones totaling up to ~USD 509 million (CHF 500 million) plus tiered royalties. Janssen leads further development.
- Feb 2014PartnershipJanssen and Minerva enter co-development and license agreement for seltorexant (MIN-202 / JNJ-42847922)Janssen Pharmaceutica NV and Minerva Neurosciences entered a co-development and license agreement for the selective orexin-2 antagonist seltorexant (JNJ-42847922 / MIN-202): Minerva held EU/EEA commercialization rights and co-development rights and paid Janssen a $22M license fee; J&J Development Corp. also took an equity stake. Janssen retained lead global development. On 2020-07-01 Minerva opted out, leaving Janssen with full development rights and Minerva entitled to a mid-single-digit royalty.
Catalysts · 2 upcoming · 7 reported
- By end-2026Anticipated
JNJ-2056 (ACI-35.030)forAlzheimer's diseaseTopline data
Phase 2b ReTain (NCT06544616): primary completion estimated 22 Dec 2026 (ClinicalTrials.gov); timing may shift given the Feb-2026 recruitment pause.
- 2H 2026 / 2027Anticipated
Seltorexant (JNJ-42847922)forMajor depressive disorderTopline data
Confirmatory Phase 3 MDD3003 anticipated; primary completion estimated end of 2026.
Recently reported
- 2026-03-21missed
PosdinemabforAlzheimer's diseaseFull results
AuTonomy Phase 2b full results (AD/PD 2026): posdinemab missed the primary iADRS endpoint - no significant difference for either dose vs placebo at week 104; key secondaries also negative; tau-PET suggested slowed neurofibrillary-tangle accumulation. Program discontinued.
- 2026-02-17pending
JNJ-2056 (ACI-35.030)forAlzheimer's diseaseInterim analysis
Phase 2b ReTain (NCT06544616): Janssen temporarily paused recruitment (17 Feb 2026); voluntary, not safety-related, pre-specified interim immunogenicity threshold met; dosing/follow-up of enrolled participants continues.
- 2025-09-25met
JNJ-2056 (ACI-35.030)forAlzheimer's diseaseFull results
Phase 1b/2a (NCT04445831) full results published in eBioMedicine: ACI-35.030 induced anti-pTau IgG in 100% of early-AD participants, no safety concerns; ACI-35.030 selected to advance.
- 2025-03-06missed
AticaprantforMajor depressive disorderTopline data
Phase 3 VENTURA program failed: J&J discontinued aticaprant for MDD on 2025-03-06 for insufficient efficacy; drug remained safe and well tolerated.
- 2024-05-29met
Seltorexant (JNJ-42847922)forMajor depressive disorderTopline data
Pivotal Phase 3 MDD3001 met all primary and secondary endpoints — significant, clinically meaningful improvement in MADRS and sleep outcomes (ASCP 2024).
- 2024-04-22met
AticaprantforMajor depressive disorderFull results
Phase 2a (NCT03559192) positive: adjunctive aticaprant 10 mg reduced MADRS vs placebo at Week 6 (LSMD -2.1; p=0.044, 1-sided); well tolerated.
- Date TBD
Seltorexant (JNJ-42847922)forMajor depressive disorderFull results
Phase 3 data comparing seltorexant to quetiapine XR as adjunctive therapy in MDD with insomnia symptoms presented at the 2025 Psych Congress.
Recent activity
- Mar 21, 2026ReadoutPosdinemab·Alzheimer's diseasemissedAuTonomy Phase 2b full results (AD/PD 2026): posdinemab missed the primary iADRS endpoint - no significant difference for either dose vs placebo at week 104; key secondaries also negative; tau-PET suggested slowed neurofibrillary-tangle accumulation. Program discontinued.source ↗
- Feb 17, 2026ReadoutJNJ-2056 (ACI-35.030)·Alzheimer's diseasependingPhase 2b ReTain (NCT06544616): Janssen temporarily paused recruitment (17 Feb 2026); voluntary, not safety-related, pre-specified interim immunogenicity threshold met; dosing/follow-up of enrolled participants continues.source ↗
- Nov 21, 2025Phase changePosdinemab·Alzheimer's diseaseDiscontinuedJohnson & Johnson announced discontinuation of the Phase 2b AuTonomy study after posdinemab did not achieve statistical significance versus placebo in slowing clinical decline (iADRS primary endpoint) at a planned review. ClinicalTrials.gov overall status: TERMINATED ('Posdinemab did not achieve statistical significance in slowing clinical decline'). Development in early Alzheimer's disease discontinued.source ↗
- Sep 25, 2025ReadoutJNJ-2056 (ACI-35.030)·Alzheimer's diseasemetPhase 1b/2a (NCT04445831) full results published in eBioMedicine: ACI-35.030 induced anti-pTau IgG in 100% of early-AD participants, no safety concerns; ACI-35.030 selected to advance.source ↗
- Mar 6, 2025ReadoutAticaprant·Major depressive disordermissedPhase 3 VENTURA program failed: J&J discontinued aticaprant for MDD on 2025-03-06 for insufficient efficacy; drug remained safe and well tolerated.source ↗
- Jan 8, 2025Phase changePosdinemab·Alzheimer's diseasePhase 2U.S. FDA granted Fast Track designation to posdinemab for early Alzheimer's disease (announced by Johnson & Johnson).source ↗
- Jul 22, 2024Phase changeJNJ-2056 (ACI-35.030)·Alzheimer's diseasePhase 2Phase 2b 'ReTain' study (NCT06544616) in preclinical AD started 22 Jul 2024 (ClinicalTrials.gov study start date). FDA Fast Track designation announced 25 Jul 2024.source ↗
- May 29, 2024ReadoutSeltorexant (JNJ-42847922)·Major depressive disordermetPivotal Phase 3 MDD3001 met all primary and secondary endpoints — significant, clinically meaningful improvement in MADRS and sleep outcomes (ASCP 2024).source ↗
- Apr 22, 2024ReadoutAticaprant·Major depressive disordermetPhase 2a (NCT03559192) positive: adjunctive aticaprant 10 mg reduced MADRS vs placebo at Week 6 (LSMD -2.1; p=0.044, 1-sided); well tolerated.source ↗
- Sep 5, 2023Phase changeJNJ-2056 (ACI-35.030)·Alzheimer's diseasePhase 1/2Phase 1b/2a study NCT04445831 (ACI-35.030 + JACI-35.054 vs placebo in early AD, n=57) completed (last participant last visit 5 Sep 2023). ACI-35.030 induced anti-pTau IgG in 100% of participants and was selected to advance.source ↗
- Jun 22, 2022Phase changeAticaprant·Major depressive disorderPhase 3Phase 3 VENTURA program initiated (VENTURA-1 NCT05455684 first patient).source ↗
- May 24, 2022Phase changeSeltorexant (JNJ-42847922)·Major depressive disorderPhase 3Phase 3 MDD3002 (NCT04532749) terminated following interim analysis on Independent Data Monitoring Committee recommendation.source ↗
Trials recruiting · 2 recruiting of 15 sponsored
- Phase 3Seltorexant (JNJ-42847922)
Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
- Phase 3Seltorexant (JNJ-42847922)
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Competitive landscape
Other companies developing against Johnson & Johnson's targets or indications.
- Cerevel Therapeutics Holdings, Inc.1 compoundKORMajor depressive disorder
- Intra-Cellular Therapies, Inc.2 compoundsMajor depressive disorderAlzheimer's disease
- Merck & Co., Inc.2 compoundsTau (pT217)Alzheimer's disease
- Neumora Therapeutics, Inc.1 compoundKORMajor depressive disorder
- Alkermes plc1 compoundOX2R
- 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
- Boehringer Ingelheim International GmbH2 compoundsMajor depressive disorder
- COMPASS Pathways plc1 compoundMajor depressive disorder