Anti-CD 19 CAR-T Cell Therapy in Patients with ANCA Vasculitis: a Two-stage Interventional, Prospective, Open-label, Phase I/II Trial in Patients with Active, Treatment Refractory, ANCA-IgG-positive Vasculitis

The goal of this phase I/II clinical trial is to investigate anti-CD 19 chimeric antigen receptor T cell (CAR-T cell) therapy in patients with antineutrophil cytoplasmic antibodies (ANCA) immunoglobulin (IgG) positive ANCA associated vasculitis (AAV).
The main questions it aims to answer are:
* To assess the safety of anti-CD19 CAR-T cell therapy in subjects with active, treatment refractory, ANCA-IgG-positive AAV
* To assess the clinical efficacy of anti-CD19 CAR-T cell therapy in subjects with active, treatment refractory ANCA-IgG-positive AAV
* To assess the ANCA seroconversion rate in subjects with active, treatment refractory ANCA-IgG-positive AAV
Participants will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR-T cell immunotherapy. Follow-up time is 52 weeks with regular visits at the site.

Start Date01 Jan 2025

Sponsor / Collaborator

Kyverna Therapeutics, Inc.

NCT06475495

/ Not yet recruitingPhase 1/2IIT

Comparison of B-cell Depletion by Rituximab and Anti-CD 19 CAR-T Therapy in Patients With Rheumatoid Arthritis. Two-stage Interventional, Prospective, Randomized, Controlled, Open Label, Parallel-group Phase I/II Trial in Patients With Active, ACPA-positive and Treatment Refractory Rheumatoid Arthritis

The goal of this phase I/II clinical trial is to compare B-cell depletion by rituximab and anti-CD 19 CAR-T therapy in patients with rheumatoid arthritis. The main questions it aims to answer are:
* To assess the safety of anti-CD19 CAR T cell therapy in subjects with active, ACPA positive and treatment refractory RA (Phase-I)
* To assess the safety of anti-CD19 CAR T cell therapy and of rituximab in subjects with active, ACPA positive and treatment refractory RA (Phase-II)
* To assess ACPA seroconversion after anti-CD19 CAR T cell or rituximab therapy in subjects with active, ACPA positive and treatment refractory RA (Phase-II)
Participants in the test-arm will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR T-cell immunotherapy. In the comparator group patients will receive 2x1 g Rituximab i.v.
Follow-up time (both arms) is 52 weeks with regular visits at the site.

Start Date01 Nov 2024

Sponsor / Collaborator

Kyverna Therapeutics, Inc.

NCT06588491

/ RecruitingPhase 2

KYSA-8: A Phase 2 Open-Label, Single-Arm, Multicenter Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell (CD19 CAR T) Therapy, in Subjects With Treatment Refractory Stiff Person Syndrome

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Treatment Refractory Stiff Person Syndrome

Start Date25 Sep 2024

Sponsor / Collaborator

Kyverna Therapeutics, Inc.

100 Clinical Results associated with KYV-101

100 Translational Medicine associated with KYV-101

100 Patents (Medical) associated with KYV-101

Literatures (Medical) associated with KYV-101

01 Nov 2025·Neurology-Neuroimmunology & Neuroinflammation

Anti-CD19 CAR T-Cell Therapy in Advanced Stiff-Person Syndrome and Concomitant Myasthenia Gravis

Article

Author: Motte, Jeremias ; Borie, Dominic ; Lohmann, Clarissa ; Aloizou, Athina-Maria ; Schroers, Roland ; Schneider-Gold, Christiane ; Mika, Thomas ; Faissner, Simon ; Ayzenberg, Ilya ; Gold, Ralf

BACKGROUND:

Autologous chimeric antigen receptor (CAR) T-cell therapy has recently gained interest in the treatment of rheumatic and neuroimmunologic diseases.

METHODS:

We report a 62-year-old female patient with a 14-year history of treatment-refractory anti-GAD-positive stiff-person syndrome (SPS) and concomitant anti-AChR-positive myasthenia gravis. Despite a relatively stable disease course in the first 8 years, SPS dramatically progressed afterward. In 2023, she was able to walk less than 10-15 m and suffered from severe persistent stiffness in the left arm superimposed with painful muscle spasm attacks (MSAs). Numerous immunotherapies, including intravenous immunoglobulins, plasma exchange, steroids, azathioprine, and rituximab, were ineffective. Consequently, she was escalated to compassionate use of autologous anti-CD19 CAR T-cell therapy (KYV-101).

RESULTS:

From the third month post-CAR-T, we observed a substantial improvement in walking distance, pain, anxiety, and MSAs in the arm. By the sixth month, she was able to walk 500 m. The anti-GAD titers declined from 1:320 to 1:32. Side effects included grade 2 cytokine release syndrome and moderate leukopenia, without serious infections.

DISCUSSION:

CAR T-cell therapy was effective at mitigating SPS symptoms, despite the long history and severe refractory disease course in our patient. Controlled trials are needed to evaluate its potential in SPS.

01 Jul 2025·Med

Chimeric antigen receptor T cells in treatment-refractory DAGLA antibody-associated encephalitis

Article

Author: Mougiakakos, Dimitrios ; Haghikia, Aiden ; Schett, Georg ; Gold, Ralf ; Pappa, Vaia ; Motte, Jeremias ; Wickel, Jonathan ; Neyazi, Alexandra ; Faissner, Simon ; Wolleschak, Denise ; Duscha, Alexander ; Böttcher, Martin ; Borie, Dominic ; Geis, Christian ; Hegelmaier, Tobias ; Miske, Ramona ; Desel, Christiane

BACKGROUND:

Autoimmune encephalitides are a heterogeneous group of autoantibody-associated central nervous system disorders. The clinical course of autoimmune encephalitides can be life threatening, and treatment can be challenging.

OBJECTIVE:

This report describes a case of treatment-refractory, anti-diacylglycerol lipase alpha (DAGLA) antibody-associated autoimmune encephalitis successfully treated with chimeric antigen receptor (CAR) T cells.

METHODS:

Treatment was done by single intravenous infusion of fully human, second-generation CAR T cells (KYV-101) targeting CD19 and depleting B cells. Clinical response was measured by International Cooperative Ataxia Rating Scale and Clinical Assessment Scale in Autoimmune Encephalitis scores. Autoantibodies against DAGLA were measured by a recombinant cell-based indirect immunofluorescence assay in the serum and the cerebrospinal fluid and confirmed by staining of primary murine neurons and brain sections.

FINDINGS:

A 36-year-old man developed rapidly progressing generalized myoclonus, cerebellar head tremor, vertical binocular nystagmus, and tetraparesis despite treatment with pulse glucocorticoid therapy, plasma exchange, and rituximab. Anti-DAGLA antibodies were positive in the indirect immunofluorescence assay, in serum and cerebrospinal fluid, and reacted with neurons and brain sections. Due to his severe clinical condition and treatment refractoriness, the patient received a single infusion of autologous anti-CD19 CAR T cells. Clinical scores improved significantly after treatment, and anti-DAGLA antibody levels in serum and cerebrospinal fluid diminished. Oligoclonal bands in the cerebrospinal fluid were initially positive and became negative after CAR T cell therapy.

CONCLUSION:

The report highlights the therapeutic potential of anti-CD19 CAR T cell therapy in severe, treatment-refractory autoimmune encephalitis.

FUNDING:

There was no external funding for the treatment or the data generated.

01 Feb 2025·CYTOTHERAPY

Successful generation of fully human, second generation, anti-CD19 CAR T cells for clinical use in patients with diverse autoimmune disorders

Article

Author: Distler, Jörg H W ; Mackensen, Andreas ; Mougiakakos, Dimitrios ; Haghikia, Aiden ; Schroers, Roland ; Schett, Georg ; Krönke, Gerhard ; Gutman, Jonathan ; Dietrich, Sascha ; Sengupta, Ranjita ; Gold, Ralf ; Bayer, Ruthee ; Kröger, Nicolaus ; Walker, Karen ; Heesen, Christoph ; Distler, Jörg H.W. ; Lorente, Mario ; Furie, Richard ; Register, Ames ; Bullinger, Lars ; Podoll, Amber ; Pendleton, Michael

BACKGROUND:

B-cell targeting chimeric antigen receptor (CAR) T-cell therapies, which lead to profound B-cell depletion, have been well-established in hematology-oncology. This deep B-cell depletion mechanism has prompted the exploration of their use in B-cell driven autoimmune diseases. We herein report on the manufacturing of KYV-101, a fully human anti-CD19 CAR T-cell therapy, derived from patients who were treated across a spectrum of autoimmune diseases.

METHODS:

KYV-101 was manufactured from peripheral blood-derived mononuclear cells of 20 patients across seven autoimmune disease types (neurological autoimmune diseases, n = 13; rheumatological autoimmune diseases, n = 7). Patients ranged from 18 to 75 years of age. Duration of disease ranged from <1 to 23 years since diagnosis. Patients were heavily pretreated, and most were refractory to prior immunosuppressive treatments. Apheresis was collected across nine sites, cryopreserved, and shipped to the manufacturing facility. Healthy donor apheresis samples were collected for manufacturing comparison. Manufacturing was performed using the CliniMACS Prodigy system. Cells were enriched for CD4⁺/CD8⁺ T cells, transduced with a third generation lentiviral vector encoding the CAR, expanded in vitro, and harvested. Percent cell viability, T-cell purity, cellular expansion, and transduction efficiency were assessed. Activity was assessed using cytokine release assays for KYV-101 CAR T cells co-cultured with different CD19^+/- target cell lines.

RESULTS:

KYV-101 was successfully manufactured for 100% of patients. Transduced cell populations were highly viable, with expansion ranging from 11 to 66 fold at Day 8, and were comparable across disease types. Healthy donor-derived controls displayed similar expansion ranges. High CAR expression and transduction rates were observed, ranging between 37 and 77% with low variation in transgene copy number (two to four per cell). Cell viability of the final KYV-101 drug product ranged from 87 to 97%. KYV-101 displayed robust CD19-dependent and effector dose-related release of the pro-inflammatory cytokine IFN-γ.

CONCLUSIONS:

KYV-101 manufacturing yielded a CAR T-cell product with high viability and consistent composition and functionality, regardless of disease indication, pre-treatment, and heterogeneity of the incoming material. Cryopreservation of the apheresis and final drug product enabled widespread distribution. These results support the robustness of the manufacturing process for the fully human KYV-101 anti-CD19 CAR T-cell therapy drug product for patients across diverse autoimmune disease types.

103

News (Medical) associated with KYV-101

05 Nov 2025

·www.globenewswire.com

Kyverna Therapeutics Secures up to $150 Million in Non-Dilutive Financing from Oxford Finance

Initial funding of $25 million from the first of four tranches Facility strengthens Kyverna’s financial flexibility, further supporting advancement of its late-stage indications in generalized myasthenia gravis (gMG) and stiff person syndrome (SPS), while also accelerating pre-launch activities Topline data readout of registrational Phase 2 SPS trial now expected in early 2026; narrowed from previous guidance of first half 2026 Nov. 03, 2025 -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX) (“Kyverna”), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that, on October 31, 2025, it closed a loan facility with Oxford Finance LLC ("Oxford Finance") for up to $150 million in non-dilutive capital. The Company will initially be drawing $25 million under the facility on November 3, 2025, with additional tranches available based on the achievement of key clinical and commercial milestones aligned with Kyverna’s growth strategy and funding needs. “We are pleased to partner with Oxford Finance on a strategic, non-dilutive financing agreement with attractive terms that strengthen our financial flexibility,” said Warner Biddle, Chief Executive Officer of Kyverna. “This facility further supports the rapid progress across our late-stage programs, including in myasthenia gravis, where we look forward to initiating enrollment in our Phase 3 registrational trial by the end of this year following positive interim Phase 2 trial data, and in stiff person syndrome, in which we are tracking ahead of schedule to report topline registrational results early next year.” “Kyverna is uniquely positioned to potentially become the first company to deliver an approved CAR T-cell therapy for an autoimmune disease and we’re proud to be partnering with this outstanding team to advance that mission,” said Kirk Andrews, Managing Director of Oxford Finance. “This investment reflects Kyverna’s continued strong execution on their strategy and the promising potential of KYV-101, as consistently demonstrated in treated patients across multiple autoimmune indications, including most recently in generalized myasthenia gravis.” The $150 million loan facility includes an initial tranche of $40 million and two additional tranches totaling $60 million, subject to the satisfaction of certain terms and conditions of the loan and security agreement. A fourth tranche of $50 million may also be made available subject to Oxford Finance’s discretion. Kyverna will be drawing $25 million from funds available from the first tranche on November 3, 2025. The facility matures on October 1, 2030. At the closing of the loan facility, Kyverna continues to expect to have cash runway into 2027, supporting its BLA filing for SPS and its MG Phase 3 trial, while also accelerating pre-launch activities. Kyverna has issued the following guidance on upcoming program milestones: SPS: Report topline registrational data in early 2026 BLA filing in 1H 2026 MG: Initiate enrollment for registrational Phase 3 trial by year-end 2025 Report updated data for the Phase 2 portion of KYSA-6 Phase 2/3 trial data in 2026 Additional Indications: Lupis Nephritis: Report Phase 1 data in a peer-reviewed publication in 2026 Future Pipeline: File IND application in Q4 2025 for KYV-102, Kyverna’s whole blood rapid manufacturing process Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating patients through the curative potential of cell therapy. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through late-stage clinical development with registrational trials for stiff person syndrome and myasthenia gravis, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications for the Company to advance into late-stage development. Additionally, its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using its proprietary whole blood rapid manufacturing process. Oxford Finance LLC is a specialty finance firm providing senior secured loans to public and private companies operating in a variety of industries worldwide. For over 20 years, Oxford Finance has delivered flexible financing solutions to over 700 companies, allowing borrowers to maximize their equity by leveraging their assets. Since 2002, Oxford Finance has originated more than $14 billion in loans. Oxford Finance is headquartered in Alexandria, Virginia, with additional offices serving the greater San Diego, San Francisco, Boston and New York City metropolitan areas. The content above comes from the network. if any infringement, please contact us to modify.

Cell TherapyImmunotherapy

30 Oct 2025

·www.biospace.com

Kyverna’s CAR T Therapy Sets ’New Efficacy Standard’ in Myasthenia Gravis, De-Risking Phase III Trials

iStock, masterzphotois With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair. Kyverna Therapeutics on Wednesday touted a 100% response rate in patients with generalized myasthenia gravis who were treated with the investigational CAR T cell therapy KYV-101, beefing up the asset’s pro it enters late-stage development. Analysts at William Blair wrote to investors that this magnitude of efficacy establishes “a new efficacy standard in the field,” making KYV-101 “differentiated from current therapies and other late-stage assets.” Wednesday’s data also “significantly” de-risks the planned Phase III trial, according to the analysts. Wednesday’s data come from the mid-stage portion of the Phase II/III KYSA-6 study, a single-arm, open-label and registrational trial testing the impact of KYV-101 on disease-related activities of daily living. At the time of readout, six patients with moderate to severe generalized myasthenia gravis (gMG) were evaluable, all of whom had previously failed immunosuppressant therapies. At 36 weeks, all six patients achieved “clinically meaningful” improvements in activities of daily living versus baseline, according to Kyverna. All treated patients also met the criteria for treatment response, which Kyverna defined as demonstrating at least a 3-point reduction in two disease inventories. Mid-stage data likewise suggest that KYV-101 could help lower treatment burden, with all treated patients being able to stop non-steroidal immunosuppressants, high-dose steroids and other therapies after 24 weeks. As for safety, Kyverna found KYV-101 to be well-tolerated, with no documented cases of high-grade cytokine release syndrome or immune effector cell–associated neurotoxicity syndrome. One patient developed grade 4—or life-threatening—neutropenia, though this complication was “expected,” according to Kyverna, and the patient had improved to grade 1 by the time of the data cutoff. Kyverna will now move on to the Phase III portion of KYSA-6, for which it expects to start enrollment by the end of this year, Chief Medical and Development Officer Naji Gehchan said in a statement on Wednesday. With these latest data, Kyverna joins Cabaletta Bio in pushing CAR T therapies, which have so far been established in cancer, into the autoimmune space. Earlier this week, Cabaletta reported promising signals of efficacy for its cell therapy rese-cel in dermatomyositis, systemic lupus erythematosus, systemic sclerosis and antisynthetase syndrome. Cabaletta Is planning to take rese-cel into a registrational study for myositis and is looking to align with the FDA on trial designs for lupus and systemic sclerosis this year. Other companies leveraging the CAR T platform for autoimmune diseases include Bristol Myers Squibb, CRISPR Therapeutics and Autolus Therapeutics.

Cell TherapyImmunotherapyPhase 2Clinical ResultPhase 3

29 Oct 2025

·www.fiercebiotech.com

Kyverna links CAR-T to improved autoimmune outcomes in small trial

Kyverna\'s CEO said new data boost his confidence in the chances of phase 3 success.\n Kyverna Therapeutics has reported deep, sustained improvements in autoimmune disease patients who received a single dose of its CAR T-cell therapy KYV-101.The data come from the phase 2 part of a trial Kyverna is running to support the registration of the cell therapy in generalized myasthenia gravis (gMG). As of the data cutoff, the biotech had results for six patients with moderate to severe gMG. The patients, who had gMG for an average of 5.3 years, had tried immunosuppressant therapies such as FcRns and complement inhibitors in the past without success.Kyverna saw an eight-point improvement on the MG-ADL scale, which measures the impact of gMG on daily functions, in the three patients with 24 weeks of follow-up. The company compared the result to the 3.1- to 4.6-point reductions seen in trials of argenx’s Vyvgart and AstraZeneca’s Ultomiris, respectively.The KYV-101 data also compare favorably to the results on Amgen’s Uplizna and Cartesian Therapeutics’ Descartes-08, both of which are in development in gMG. Both companies have seen 4.2-point changes on the scale. Descartes-08 is an mRNA CAR-T therapy. But, whereas KYV-101 is a CD19 treatment with CD28 co-stimulation, Cartesian’s asset engages BCMA. MG-ADL is the primary efficacy endpoint in the phase 2 trial and one of two co-primary endpoints in the phase 3 part of the study. The other phase 3 primary endpoint is quantitative myasthenia gravis (QMG), another measure of disease severity. Kyverna saw a 7.7-point drop on QMG in the phase 2 trial, compared to declines of between 2.8 and 6.2 points in its rivals’ trials.Stanford Medicine’s Srikanth Muppidi, M.D., commented on the efficacy data on a call Kyverna held to discuss the results with analysts. Muppidi said the data are “quite promising” but flagged factors that could have affected the cross-trial comparisons. Patients in the Kyverna trial had a significant disease burden that was higher than in some phase 3 studies published to date, Muppidi said.Two of the three patients had minimal symptom expression by Week 24. Kyverna CEO Warner Biddle said on the call that all the other patients in the trial were trending toward minimal symptom expression. On the safety front, all six patients had cytokine release syndrome, a common side effect of CAR-Ts. Two of the cases were grade 2 and the other four were grade 1, indicating relatively mild effects. No patients had immune-effector-cell-associated neurotoxicity syndrome, another common CAR-T side effect. There were grade 3 and 4 cases of low neutrophils, a type of white blood cell, linked to lymphodepletion. Biddle said the data boost his confidence in chances of phase 3 success because the results exceeded the magnitude of effect assumed for the pivotal study’s primary endpoint. The biotech is enrolling 60 people in the phase 3 part of the study, which will compare KYV-101 to standard of care.Kyverna is part of a group of companies developing CAR T-cell therapies in gMG. The group includes Cartesian’s BCMA program and CD19-directed CAR-T therapies that are in clinical development at Cabaletta Bio and Novartis.

Clinical ResultPhase 3Cell TherapyPhase 2Immunotherapy

100 Deals associated with KYV-101

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Myasthenia Gravis	Phase 3	United States	Kyverna Therapeutics, Inc.	28 Aug 2024
Myasthenia Gravis	Phase 3	Germany	Kyverna Therapeutics, Inc.	28 Aug 2024
Granulomatosis With Polyangiitis	Phase 2	-	Kyverna Therapeutics, Inc.	01 Jan 2025
Microscopic Polyangiitis	Phase 2	-	Kyverna Therapeutics, Inc.	01 Jan 2025
Rheumatoid Arthritis	Phase 2	-	Kyverna Therapeutics, Inc.	01 Nov 2024
Ischiopatellar Dysplasia	Phase 2	United States	Kyverna Therapeutics, Inc.	25 Sep 2024
Stiff-Person Syndrome	Phase 2	United States	Kyverna Therapeutics, Inc.	25 Sep 2024
Multiple Sclerosis, Primary Progressive	Phase 2	United States	Kyverna Therapeutics, Inc.	20 Sep 2024
Multiple Sclerosis, Secondary Progressive	Phase 2	United States	Kyverna Therapeutics, Inc.	20 Sep 2024
Scleroderma, Diffuse	Phase 2	United States	Kyverna Therapeutics, Inc.	06 Aug 2024

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06193889 (KYSA-6, GlobeNewswire) Manual	Phase 2/3	Myasthenia Gravis	6	KYV-101	eqjuhujkac(priapssjia) = xslebzjcds aulhshtlfr (mexfnllwxp ) View more	Positive	29 Oct 2025
NCT06342960 \| NCT05938725 (KYSA-3, PRNewswire) Manual	Phase 1/2	Lupus Nephritis	6	KYV-101	wvatctzxfr(liyiwumxbi) = No High-Grade CRS or ICANS Observed. vqqyolmtlm (itqptunlfp ) View more	Positive	14 Nov 2024
Company_Website Manual	Not Applicable	Multiple Sclerosis \| Myasthenia Gravis \| Neuroinflammatory Diseases ... View more	41	KYV-101	luuzgifich(okoijvyytm) = In stiff-person syndrome, two patients treated with KYV-101 have demonstrated improved mobility and/or walking speed and reduced autoantibody titers, including one patient at greater than one year post-infusion. A third patient demonstrated reduced autoantibody titers but does not yet have mobility scores available. In myasthenia gravis, three patients treated with KYV-101 have shown reduced pathogenic anti-AChR antibody titers and sustained disease control, including two patients at more than one year post-infusion and all three at greater than 8 months post-infusion. In multiple sclerosis, five patients treated with KYV-101 who failed prior anti-CD20 medications have shown a significant and unprecedented average reduction in oligoclonal bands in the central nervous system (CNS), a potential surrogate biomarker for reduced disease progression. yisfdspjxu (xrbjxbbceh ) View more	Positive	18 Sep 2024
PRNewswire Manual	Not Applicable	Stiff-Person Syndrome	1	KYV-101	coorpgybgk(urhpzxirao) = xjnamfsezs xbnrvifacz (pcvykpksqp )	Positive	17 Jun 2024
NEWS 1 \| NEWS 2	Not Applicable	Lupus Nephritis	50	KYV-101	uhnqpsdmxt(kyijkufnzf) = bnulumfgtj niryhfmsum (guynqeadmv )	Positive	14 Jun 2024
PRNewswire Manual	Not Applicable	Myasthenia Gravis	1	KYV-101	acaivthhnz(gnnpjezrlb) = qucsieaoww pwcctbmfgd (yzechecupz ) View more	Positive	15 Nov 2023

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