This is a list of investigational bipolar disorder drugs, or drugs that are currently under development for clinical use for the treatment of bipolar disorder (manic depression) and related conditions but are not yet approved. Bipolar disorder and related conditions include bipolar I disorder, bipolar II disorder, cyclothymia, manic episodes, bipolar depression, and schizoaffective disorder (bipolar/manic and mixed types). Chemical/generic names are listed first, with developmental code names, synonyms, and brand names in parentheses. The format of list items is "Name (Synonyms) – Mechanism of Action – Indication [Reference]". This list was last comprehensively updated in May 2026. It is likely to become outdated with time.
Under development
Preregistration Lurasidone (DSP-1349M; Latuda; SM-13496; SMP-13496) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders [1]
Phase 3 ALM-008 – undefined mechanism of action (mood stabilizer) – bipolar disorders [2] Azetukalner (1OP-2198; encukalner; VRX-621698; XEN-1101; XPF-008) – Kv7.2 and Kv7.3 potassium channel opener – bipolar depression [3] Brenipatide (LY-3537031) – glucagon-like peptide-1 (GLP-1) receptor agonist and gastric inhibitory polypeptide (GIP) receptor agonist – bipolar disorders [4] Brexpiprazole (Lu-AF41156; OPC-34712; OPDC-34712; Rexulti; Rxulti) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders [5] Cycloserine/lurasidone (Cyclurad; D-cycloserine/lurasidone; lurasidone/cycloserine; NRX-101) – combination of cycloserine (ionotropic glutamate NMDA receptor glycine site partial agonist) and lurasidone (atypical antipsychotic/non-selective monoamine receptor modulator) – bipolar depression [6] Endoxifen (4-hydroxy-N-desmethyltamoxifen; Z-endoxifen) – selective estrogen receptor modulator (SERM) and protein kinase C (PKC) inhibitor – bipolar disorders [7] Lumateperone (Caplyta; ITI-007; ITI-722) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders [8] Risperidone extended release (LYN-005) – atypical antipsychotic (non-selective monoamine receptor modulator) – schizoaffective disorder [9] SEP-4199 (non-racemic amisulpride; aramisulpride/esamisulpride [85:15 ratio]) – dopamine D2 and D3 receptor antagonist and serotonin 5-HT2B and 5-HT7 receptor antagonist – bipolar depression [10] Xanomeline/trospium chloride (BMS-986510; Cobenfy; KarXT; LY-246708/trospium chloride) – combination of xanomeline (non-selective muscarinic acetylcholine receptor agonist) and trospium chloride (peripherally selective non-selective muscarinic acetylcholine receptor antagonist) – bipolar disorders [11]
Phase 2/3 Opakalim (BHV-7000; BPN-25203; KB-3061) – Kv7.2 and Kv7.3 potassium channel opener – bipolar disorders [12]
Phase 2 Aldesleukin (ILT-101; interleukin-2; IL2; IL-2) – recombinant interleukin-2 (IL-2) replacement (interleukin-2 receptor agonist) – bipolar disorders [13] Amdiglurax (ALTO-100; NSI-189) – unknown mechanism of action (hippocampal neurogenesis stimulant and indirect brain-derived neurotrophic factor (BDNF) modulator) – bipolar depression [14] Brilaroxazine (RP-5000; RP-5063) – atypical antipsychotic (non-selective monoamine receptor modulator) – schizoaffective disorder [15] Cenobamate (ONO-2017; Ontozry; senovamate; X-Copri; XCopri; YKP-3089) – voltage-gated sodium channel (VGSC) blocker and GABA release enhancer – bipolar disorders [16] Desmethyl cariprazine prodrug (ABBV-932; RGH-932) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar depression, bipolar disorders [17] Direclidine (HTL-0016878; NBI-1117568; NBI-568) – muscarinic acetylcholine M4 receptor agonist – bipolar I disorders [18] Ebselen (DR-3305; ebselene; ebseleno; ebselenum; harmokisane; PZ-51; SPI-1005; SPI-3005) – various actions – bipolar disorders [19] Elunetirom (ABX-002) – thyroid hormone receptor beta (TRβ) agonist – bipolar depression [20] Icalcaprant (ABBV-1354; CVL-354) – κ-opioid receptor antagonist – bipolar depression [21] JNJ-8942 – undefined mechanism of action – bipolar disorders [22] JNJ-18038683 – serotonin 5-HT7 receptor antagonist – bipolar disorders [23] JNJ-55308942 – purine P2X7 receptor antagonist – bipolar depression [24] Lithium cocrystal (AL-001-Alzamend Neuro; lithium salicylate/L-proline cocrystal) – undefined mechanism of action (mood stabilizer) – bipolar disorders, bipolar I disorders [25] N-Methylamisulpride (LB-102) – dopamine D2 and D3 receptor antagonist and serotonin 5-HT2B and 5-HT7 receptor antagonist – bipolar depression [26] Navacaprant (BTRX-140; BTRX-335140; CYM-53093; NMRA-140; NMRA-335140) – κ-opioid receptor antagonist – bipolar depression [27] OSU-6162 (PNU-9639; PNU-96391; PNU-96391A) – dopamine D2 receptor agonist, serotonin 5-HT2A receptor agonist, and so-called "dopamine stabilizer" – bipolar depression [28] Psilocybin (COMP360; COMP-360) – non-selective serotonin receptor agonist, serotonin 5-HT2A receptor agonist, and psychedelic hallucinogen – bipolar depression [29] RAP-219 – AMPA receptor negative allosteric modulator – bipolar disorders [30] Vortioxetine (Brintellix; LU-AA21004; LuAA 21004; Trintellix; Vortidif) – serotonin reuptake inhibitor, serotonin 5-HT1A and 5-HT1B receptor agonist, and serotonin 5-HT1D, 5-HT3, and 5-HT7 receptor antagonist – bipolar depression [31] Zuranolone (BIIB-125; S-812217; SAGE-217; SGE-797; Zurzuvae) – GABAA receptor positive allosteric modulator and neurosteroid – bipolar depression [32]
Phase 1/2 Cariprazine (cariprazine depot) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders [33]
Phase 1 Brilaroxazine (RP-5000; RP-5063) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders [34] CB03-154 (CB-03; CB-003) – Kv7.2 and Kv7.3 potassium channel opener – bipolar disorders [35] Scopolamine (DPI-385-CVS; DPI-386; DPI-386 Nasal Gel; DPI-386-SG; DPI-386-SS; DPI-387; DPI-521-CG; DPI-550-TBI; Inscop spray) – non-selective muscarinic acetylcholine receptor antagonist – bipolar depression [36]
Clinical phase unknown LTX-001 – glutaminase inhibitor – bipolar disorders [37] Quetiapine oral suspension – non-selective monoaminer eceptor modulator – bipolar disorders [38]
Preclinical Estianeptine ((S)-tianeptine; TNX-4300) – peroxisome proliferator-activated receptor PPARβ/δ and PPARγ agonist [39]
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