Assessing residual inflammation and macrophage presence in lupus nephritis after 3 months of intensified treatment with prednisolone, mycofenolate mofetil and voclosporin as compared to mycofenolate mofetil and prednisolone: an open label randomized controlled trial (MAPLE study)

Start Date01 Jan 2026

Sponsor / Collaborator-

NCT07053891

/ RecruitingNot Applicable

LUPKYNIS Drug-use Results Survey

The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.

Start Date17 Sep 2025

Sponsor / Collaborator

Otsuka Pharmaceutical Co., Ltd.

CTR20250444

/ CompletedNot Applicable

伏环孢素软胶囊在空腹条件下的人体生物等效性试验

[Translation] Bioequivalence study of cyclosporine soft capsules in humans under fasting conditions

考察健康受试者在空腹条件下，单次口服1粒由杭州中美华东制药有限公司提供的伏环孢素软胶囊（受试制剂T，规格：7.9mg）与单次口服1粒由Aurinia Pharmaceuticals, Inc.持证的伏环孢素软胶囊（参比制剂R，商品名：Lupkynis®，规格：7.9mg）的药动学特征，评价两制剂的生物等效性及安全性，为该受试制剂注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral dose of cyclosporine soft capsule (test preparation T, specification: 7.9 mg) provided by Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd. and a single oral dose of cyclosporine soft capsule (reference preparation R, trade name: Lupkynis®, specification: 7.9 mg) certified by Aurinia Pharmaceuticals, Inc. in healthy subjects under fasting conditions, and to evaluate the bioequivalence and safety of the two preparations, so as to provide a basis for the registration application of the test preparation.

Start Date16 Feb 2025

Sponsor / Collaborator

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

100 Clinical Results associated with Voclosporin

100 Translational Medicine associated with Voclosporin

100 Patents (Medical) associated with Voclosporin

149

Literatures (Medical) associated with Voclosporin

01 Mar 2026·AMERICAN JOURNAL OF KIDNEY DISEASES

“A Change Is Gonna Come” to Treatment of Lupus Nephritis: A Review

Review

Author: Gashti, Casey ; Desai, Niraj B ; Whittier, William L

Systemic lupus erythematosus (SLE) is a chronic, multiorgan autoimmune disease, with lupus nephritis (LN) affecting up to 60% of patients. Early diagnosis and treatment are critical for preserving kidney function. Advances in understanding the immunopathogenesis of LN are driving the development of personalized treatment strategies that hold promise for transforming disease management through interventions targeting distinct immunologic and histopathologic features. In this review, we discuss current and emerging therapies for proliferative and membranous LN with a focus on strategies targeting underlying mechanisms of disease in LN. Glucocorticoids with cytotoxic agents or mycophenolate mofetil (MMF) remain the standard of care, but newer therapies targeting B cells (eg, belimumab and obinutuzumab) and T cells (eg, voclosporin) have proven efficacy as add-on treatments. Novel therapies such as complement and cytokine inhibitors are being evaluated in preclinical and clinical trials. Although maintenance therapy with MMF remains the standard, the distinction between sequential induction and maintenance therapy has become increasingly blurred, and new strategies to reduce long-term disease and pharmacologic toxicity to improve remission and relapse rates are emerging.

29 Jan 2026·Cureus Journal of Medical Science

Two-Hour Post-dose (C2)-Monitored Cyclosporine Microemulsion as a Practical Alternative to Voclosporin in Mixed Class IV/V Lupus Nephritis: A Case Report

Article

Author: Akella, Divya ; Ramoutar, Virin

Lupus nephritis (LN) is a major cause of chronic kidney disease and progression to end-stage kidney disease in patients with systemic lupus erythematosus. Calcineurin inhibitor-based therapy is used in LN management because of its combined systemic immunomodulatory effects on T-cell activation and direct podocyte-stabilizing actions, leading to reduction in proteinuria. We report a patient with mixed class IV and V LN who achieved partial remission with voclosporin but was unable to continue therapy. Transition to cyclosporine microemulsion (CsA-ME) guided by two-hour post-dose (C2) monitoring was associated with complete proteinuric remission and stable kidney function during follow-up. This case demonstrates that individualized C2-guided CsA-ME dosing was associated with marked proteinuria reduction and preservation of kidney function. The observed response suggests pharmacodynamic effects that may overlap with those reported for voclosporin, within a fully oral, non-depletive regimen selected to mitigate treatment-related toxicity from cytotoxic therapy after shared decision-making with the patient.

08 Jan 2026·RHEUMATOLOGY

Early antiproteinuric effect of voclosporin in patients with LN in a real-life setting: preliminary results from the VoRLiSS ( Vo closporin in R eal L ife S etting S tudy) experience

Article

Author: Picciotto, Daniela ; Di Gregorio, Aurora ; Bortoluzzi, Alessandra ; Allinovi, Marco ; Esposito, Pasquale ; Ruzzon, Francesca ; Moroni, Gabriella ; Fredi, Micaela ; Buscetta, Giorgio ; Quartuccio, Luca ; De Angelis, Rossella ; Doria, Andrea ; Ferio, Cinzia ; Pazzola, Giulia ; De Marchi, Ginevra ; Santoro, Domenico ; Orsolini, Giovanni ; Marongiu, Giuliana ; Franceschini, Franco ; Silvagni, Ettore ; Zen, Margherita ; Calatroni, Marta ; Vesentini, Filippo ; Tomietto, Paola ; Emmi, Giacomo ; Iaccarino, Luca ; Fenaroli, Paride ; Gozza, Francesco

Abstract:

Objective:

To assess efficacy of voclosporin (VCL) from a retrospective, observational, clinical-practice-based, nationwide multicentre study of patients with LN.

Methods:

Patients with biopsy-proven LN were enrolled from November 2023 to April 2025 from tertiary Rheumatology and Nephrology Italian Centres. Those with uncontrolled arterial hypertension and eGFR < 30 ml/min/1.73 m2 were excluded. Patients received oral 23.7 mg VCL BID and MMF 1 g BID. Glucocorticoid schedule followed existing recommendations for LN management. Clinical and serological data were collected at SLE diagnosis, VCL initiation and after 6, 12, 24 and 48 weeks. Complete renal response (CRR) was defined as eGFR ≥ 60 ml/min/1.73 m2, <20% eGFR decrease from baseline, 24-h proteinuria <0.5 g/day, no rescue therapy, prednisone ≤5 mg/day and partial renal response (PRR) as a 50% decrease of 24 h proteinuria and <20% eGFR decrease.

Results:

Forty-two patients from 14 centres were enrolled, 26 females (61.9%), mean age 43.1 ± 11.9 years, follow-up 6.6 ± 5.1 months. A total of 31.5% of patients achieved CRR or PRR at 6 weeks, 68.9% at 12 weeks, 83.3% at 24 weeks and 91.6% at 48 weeks of follow-up. A significant decrease in 24-h proteinuria was observed at 6 weeks (P = 0.006) and at all subsequent time points. A mild eGFR decrease was observed at 6 (P = 0.008) and 24 weeks (P = 0.01), but not at 48 weeks. Significant decrease was also observed in anti-dsDNA positivity at 6 (P = 0.0016) and 12 weeks (P = 0.0009), and in SLEDAI-2K after 24 (P = 0.008) and 48 weeks (P = 0.05).

Conclusions:

VCL may provide a valuable therapeutic option in LN management, achieving early 24 h-proteinuria response consistent with clinical trial data.

181

News (Medical) associated with Voclosporin

31 Mar 2026

·www.businesswire.com

Aurinia Pharmaceuticals to Acquire Kezar Life Sciences for $6.955 in Cash per Share Plus a Contingent Value Right

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH), a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs, announced today it has entered into a definitive merger agreement (the “Merger Agreement”) to acquire Kezar Life Sciences, Inc. (NASDAQ: KZR), a biotechnology company focusing on small-molecule therapeutics to treat unmet needs in autoimmunity and cancer, for $6.955 in cash per share of Kezar common stock, plus one non-transferable contingent value right (“CVR”), which represents the right to receive: (i) potential payments relating to the ongoing clinical development or disposition of zetomipzomib; (ii) certain proceeds relating to Kezar’s collaboration with Everest Medicines and Kezar’s sale of its Sec61‑based discovery and development program to Enodia Therapeutics; and (iii) 100% of Kezar’s closing net cash in excess of $50 million, net of certain post-closing CVR-related expenses. Following a strategic review process conducted by the Kezar board of directors with the assistance of Kezar’s management and external legal and financial advisors, the Kezar board of directors has unanimously: (i) determined that the acquisition by Aurinia is in the best interests of Kezar and its stockholders; and (ii) approved the execution and delivery of the Merger Agreement and the consummation of the transactions contemplated thereby. Zetomipzomib, Kezar’s lead product candidate, is a first-in-class immunoproteasome inhibitor in development for patients with autoimmune hepatitis (AIH), lupus nephritis and systemic lupus erythematosus (SLE). Zetomipzomib demonstrated clinically meaningful and durable steroid-sparing remissions in the PORTOLA Phase 2 AIH study. Kezar had positive interactions with the US Food and Drug Administration (FDA) in a recent Type C meeting aimed to accelerate the development of zetomipzomib in AIH. “We are pleased to conclude our strategic review process with this agreement with Aurinia, which will provide immediate liquidity to our shareholders, as well as ongoing participation in the value of zetomipzomib. With its successful track record developing and commercializing treatments for autoimmune diseases, Aurinia is well positioned to continue the development of this novel therapeutic agent,” said Chris Kirk, Chief Executive Officer of Kezar. Pursuant to the terms of the Merger Agreement, Aurinia will, through its wholly owned subsidiary, Aurinia Pharma U.S., Inc., and its merger subsidiary, Aurinia Merger Sub, Inc., commence a tender offer (the "Offer") by April 13, 2026, to acquire all outstanding shares of Kezar common stock. The closing of the Offer is subject to certain conditions, including the tender of shares of Kezar common stock representing at least a majority of the total number of outstanding shares, Kezar having closing net cash in excess of $50 million, net of certain post-closing CVR-related expenses and other customary closing conditions. Immediately following the closing of the Offer, Kezar will be acquired by Aurinia, and all remaining shares not tendered in the Offer, other than shares owned directly or indirectly by Aurinia or Kezar or a subsidiary thereof or validly subject to appraisal, will be converted into the right to receive the same cash and CVR consideration per share as is provided in the Offer. Tang Capital Partners, LP, which holds approximately 9.0% of Kezar's outstanding common stock, has signed a tender and support agreement under which it has agreed to tender its shares in the Offer and support the transaction. The transaction is expected to close in the second quarter of 2026. Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, Aurinia introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultAcquisitionDrug ApprovalImmunotherapy

30 Mar 2026

·www.fiercebiotech.com

Kevin Tang uses newfound control of Aurinia to finally take over Kezar

After Kezar rejected an offer for $1.10 per share in 2024, it sold for $6.95 per share this week.\n After being knocked back in 2024, serial biotech acquirer Kevin Tang has used a different route to finally get his hands on Kezar Life Sciences. The acquisition of Kezar is coming from autoimmune specialist Aurinia Pharmaceuticals, which named Tang as its new CEO last week. Aurinia is paying $6.95 cash per share of Kezar. With 7.32 million shares outstanding as of March 23, according to Kezar’s most recent SEC filing, Fierce calculates that this morning’s deal values Kezar at just over $50 million.Tang previously made an unsuccessful attempt in 2024 to acquire Kezar via Concentra Biosciences and its parent company, Tang Capital Partners. Back then, Tang made a more modest offer of $1.10 per share after two clinical holds were placed on Kezar’s lead asset zetomipzomib, an immunoproteasome inhibitor being developed for autoimmune hepatitis (AIH), lupus nephritis and systemic lupus erythematosus (SLE). Still, this morning\'s offer is barely above the $6.20 share price that Kezar\'s stock closed trading at on Friday.The deal with Aurinia also includes a non-transferable contingent value right (CVR), which entitles shareholders to potential future payments tied to the development or sale of zetomipzomib. It also incorporates proceeds from Kezar’s sale of its preclinical protein degradation program to Encodia Therapeutics earlier this month, as well as a 2023 collaboration with Everest Medicines, which also relates to zetomipzomib.Concentra Biosciences’ prior offer of $1.10 per share exceeded Kezar’s stock price at the time but was rejected by the company’s board, which argued that the bid “substantially undervalued” the biotech.At the time, Tang already owned a 9.9% stake in Kezar. The offer prompted the company to adopt a “rights plan” that imposed significant penalties on any party attempting to acquire more than 10% of its shares. In July 2025, the FDA lifted its hold on a phase 2a study in AIH patients. However, despite “encouraging” results, Kezar announced last October that it had been unable to align with the FDA on a registrational trial for zetomipzomib and would explore strategic alternatives.In January, Kezar announced a Type C meeting with the FDA to review data in AIH, with the meeting resulting in agreement on treatment duration, safety monitoring, endpoints and enrollment criteria for its next study. A note from William Blair analysts released shortly before the acquisition was announced today indicated that the firm did not expect Kezar to move forward with the trial, though they speculated that the positive regulatory update could attract a potential partner. Tang was able to swoop in for a second attempt to pick up Kezar after serving as board chair of Aurinia since 2024. He was named CEO last week, alongside several leadership changes that brought in his close associates to the company’s executive team. He has built a reputation for taking over struggling biotech firms.Aurinia had previously sought to be on the other side of an acquisition. After conducting a “robust strategic review” with J.P. Morgan in 2023, the company approached more than 60 potential buyers. When no deal materialized, Aurinia laid off 25% of its staff and scaled back its R&D pipeline. Today, in addition to its approved drug Lupkynis, the company lists one autoimmune treatment in phase 1 development.

AcquisitionPhase 2Phase 1IPOExecutive Change

30 Mar 2026

·www.biospace.com

After Missing Kezar Buyout in 2024, Tang Returns as CEO of Aurinia With $50M Offer

iStock, Yutthana Gaetgeaw Serial biotech investor Kevin Tang previously unsuccessfully tried to buy Kezar Life Sciences via Concentra Biosciences, a biotech consolidation company owned by the venture capital firm he runs. In one of his first major acts as CEO of Aurinia Pharmaceuticals, Kevin Tang is circling back around to a previous target. The serial investor, known for buying out failing biotechs and shutting them down, is offering to buy Kezar Life Sciences, a biotech that his consolidation company Concentra Biosciences previously attempted to purchase. Aurinia, which came under Tang’s control last week, has offered about $6.95 per share, which represents a deal value of about $50 million. Kezar currently has a market cap of about $47 million. The deal could close in the second quarter, according to a regulatory filing . Tang originally targeted Kezar after four patients died in a clinical trial of zetomipzomib in lupus nephritis, eliciting an FDA clinical hold on multiple programs. The stock had been trading below a dollar for months prior to the deaths. Concentra, which is owned by Tang Capital Management, at which Tang serves as CEO, offered $1.10 per share. The deal ultimately did not go through. Kezar has continued to struggle, conducting a strategic review and laying off a chunk of its workforce in November 2025. Earlier this month, Kezar sold its early stage pipeline to Enodia Therapeutics for $1 million upfront plus potential milestones totaling $127 million. Mergers & acquisitions Tang Capital’s Concentra on Buyout Binge With Plenty of Biotech Fodder After a slow 2024, the biotech shell company Concentra Biosciences is back, offering to buy four biotechs in the past month and seven so far this year. August 13, 2025 · 4 min read · Annalee Armstrong Read more Meanwhile, Kezar has been trying to find agreement with the FDA to move zetomipzomib forward. The agency in January granted a new meeting to discuss a mid-stage trial of the drug in autoimmune hepatitis, slated to take place in the first quarter of this year. But now, in steps Aurinia, fresh off its own transformation. Tang, via his Tang Capital Partners firm, already owned 9% of Kezar’s shares. These will be tendered to Aurinia if the transaction succeeds. Tang has been a prolific biotech buyer through his various investment firms and shell companies like Concentra. That company was one of biopharma’s most prolific buyers in the first half of 2025. Companies that come into Tang’s orbit do not typically last long. Tang and his team typically work fast to dismantle them, selling off any profitable pieces and returning some cash to shareholders, then reaping the remaining rewards. Just like Kezar, Aurinia’s journey with Tang has been tumultuous. He joined the company’s board in 2024 while growing his stake, ultimately upping his ownership to 9.2% last month—enough to stage a remake of the C-suite. Tang himself took the CEO chair, replacing Peter Greenleaf, while other allies snagged other top leadership positions. Last fall, the FDA’s George Tidmarsh drew Tang’s ire by posting on social media that Aurinia’s Lupkynis had “significant toxicity” and no clinical benefit. Tang filed a complaint with the agency and a lawsuit accusing Tidmarsh of a “longstanding personal vendetta against Kevin Tang.” Tidmarsh ultimately left the agency amid an investigation into his “personal conduct.”

AcquisitionExecutive ChangeIPO

100 Deals associated with Voclosporin

External Link

KEGG	Wiki	ATC	Drug Bank
D09033	Voclosporin	L04AD03	DB11693

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lupus Nephritis	United States	Aurinia Pharmaceuticals, Inc.	22 Jan 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dry Eye Syndromes	Phase 3	United States	Aurinia Pharmaceuticals, Inc.	14 Oct 2019
Kerato conjunctivitis sicca	Phase 3	United States	Aurinia Pharmaceuticals, Inc.	14 Oct 2019
Acute rejection of renal transplant	Phase 3	-	Aurinia Pharmaceuticals, Inc.	01 Mar 2013
Uveitis	Phase 3	United States	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Austria	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Brazil	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Canada	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Czechia	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	France	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Germany	Lux Biosciences, Inc.	01 Feb 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2025	Not Applicable	Lupus Nephritis	19	Voclosporin (Lupus Nephritis)	wytgduicjc(pziqabxdjf) = ietueuzfwd afqfsmditu (ljddndjkhs ) View more	Positive	08 Nov 2025
NCT05306873 (DIVERT, CTgov)	Phase 2	Systemic Lupus Erythematosus	12	MMF (Stage 2 MMF)	entijzixje = rpnmzflzbt ellhhjjuyu (aygqxmcynf, akxfxltcyp - wcjngonyni) View more	-	09 Sep 2025
				MMF (Stage 2 Placebo for MMF)	entijzixje = zsfnfapqnc ellhhjjuyu (aygqxmcynf, jtysslnxua - itckguvqjf) View more
AURORA 1 (ACR2024)	Phase 3	Lupus Nephritis	357	Voclosporin 23.7 mg BID	wnkfrrjvzg(rgvabuvezz) = igcbsurmlk icoklvhivd (ojqlxouggv )	Positive	10 Nov 2024
				Placebo	wnkfrrjvzg(rgvabuvezz) = yrxoynsoir icoklvhivd (ojqlxouggv )
NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	25	LUPKYNIS, MMF, and steroids	tusimonmfs(xoajnkiukw) = ulqcubmthh crxgumdywj (pbiyxpxtze )	Positive	09 May 2024
				MMF and glucocorticoids	tusimonmfs(xoajnkiukw) = dioolkxwvi crxgumdywj (pbiyxpxtze )
NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	-	LUPKYNIS	hkwvfnhmqf(cpzgyvjzmp) = zwuvfccuul dhgrvtqdyo (vheyxwrvwz )	Positive	09 May 2024
NCT03021499 (phase 3 study, Pubmed)	Phase 3	Lupus Nephritis	148	Voclosporin	vzimebmqgr(muqaqkzlos) = The incidence of adverse events was similar between the arms; mean eGFR values remained stable and within normal range in both arms zeebeasnbk (xuuisbqkhh ) View more	Positive	18 Dec 2023
				Placebo
ACR2023	Not Applicable	Proteinuria	-	Voclosporin	aebivswpig(qlraxlscim) = msdtpdyxyh ksfkrqcdfk (fwarvfogld ) View more	-	14 Nov 2023
				Placebo	aebivswpig(qlraxlscim) = ghbjcapxja ksfkrqcdfk (fwarvfogld ) View more
NCT03021499 \| NCT02141672 (AURORA 1, Biospace) Manual	Phase 2/3	Lupus Nephritis	-	LUPKYNIS® + MMF+ glucocorticoids (proteinuria >=2 g/day)	kpmgshrbbn(vfwvepikko) = greater numeric achievement of complete renal response across biopsy classes, races, and ethnicities in LN patients with proteinuria >=2 g/day acwxoftpwv (ynpnfvxict ) View more	Positive	07 Nov 2023
				LUPKYNIS® + MMF+ glucocorticoids (UPCR ≥2 g/g at baseline)
NCT03597464 (AURORA 2, Biospace) Manual	Phase 3	Lupus Nephritis	26	LUPKYNIS® in combination + MMF + glucocorticoids	umlwkxocit(ncqxllkkan) = experienced numerically greater mean reductions czukmmbkhe (fjbyvrzigj ) View more	Positive	07 Nov 2023
				MMF + glucocorticoids
NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	-	LUPKYNIS + MMF + glucocorticoids (Black patients)	mbvoaddydi(mgbxosivrr) = lbdbyuoxgz vdkuoucbbm (kiykfdoeeo )	Positive	07 Nov 2023
				MMF + glucocorticoids (Black patients)	mbvoaddydi(mgbxosivrr) = maxxfhrbcu vdkuoucbbm (kiykfdoeeo )

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