TheraRadar
Landscape / Immunology
Page updated Sep 30, 2026 · using data updated on Nov 12, 2026

Sjogren's Disease Clinical Trial Landscape

Sjogren's Disease is being studied across 147 clinical trials registered since 2008, with 57 programs currently active. The competitive pipeline includes 6 active Phase 3 trials, 27 active Phase 2 trials, and 19 active Phase 1 trials.

Top industry sponsors include Bristol-Myers Squibb, Novartis, Amgen.

Trial activity

57 active / 147 total since 2008
Active by phase 6 Ph3 / 23 27 Ph2 / 79 19 Ph1 / 29 5 Ph4 / 16

Competitive Intelligence

This Sjogren's Disease competitive landscape maps 11 companies against 5 mechanisms of action (MOA) across 11 active drug-development programs. Each cell is the lead program for a company–mechanism pair — its trial phase, modality, combination, and nearest readout. Read down a column to see who is competing on the same mechanism in Sjogren's Disease, across a row to see one company's mechanistic spread, and click any cell for the full program list and trial links.

Beta 11 companies 5 mechanisms 11 programs mapped 1 lowTrust (9%) ⏰ 2 due ≤6 mo click any cell → asset tearsheet
The competitive read

The clinical development landscape for Sjögren’s Disease is currently defined by a reliance on mature mechanisms, as no emerging classes have yet reached regulatory approval. Competitive activity is concentrated within established pathways, specifically BAFF/APRIL inhibitors, FcRn inhibitors, and anti-BAFF-R monoclonal antibodies, which account for the majority of active programs. While companies like Novartis, Amgen, and argenx lead the field in program volume, these efforts largely focus on refining existing therapeutic targets rather than introducing novel biological modalities. The pipeline remains heavily weighted toward these mature classes, with only five NME candidates and one Phase 2 first-in-class program currently in development. With three readouts expected within the next six months and three trials currently listed as stale, the sector remains in a period of consolidation around proven, albeit unapproved, biological targets.

Key findings
  • Top 3 mechanisms (BAFF/APRIL inhibitor, FcRn inhibitor, Anti-BAFF-R (mAb)) account for ~55% of programs — class concentration is moderate.
  • Novartis runs 4 programs — the deepest pipeline in this view.
  • Amgen has the highest composite score (100) — most-imminent / most-advanced asset weighted higher than program count.
  • 3 hot readouts in next 6 months — most imminent: Amgen (Anti-CD40L).
  • 5 single-program mechanisms in the long tail — 1 are Ph2+ first-in-class first-mover bets.
  • 5 NME candidates in the long tail.
  • Most-novel-of-novel: Lubris Bio PRG4 (Ph2) — first-in-class within scope + NME candidate.

Forward catalysts next 18 months⏰ 2 due ≤6 mo

Nearest first. ⚖ Confirmed FDA PDUFA dates (curated calendar, primary sources) and 📅 estimated readouts (ClinicalTrials.gov primaryCompletionDate — a timing proxy, not a confirmed action date). Red = due within 6 months.

Company × Mechanism

Each cell = a company’s most-advanced program in that mechanism. Click for the asset tearsheet.
Unverified (lowTrust) cells:
Ph1 Ph2 Ph3 Ph4 ⚠ lowTrust +combo
Select & Focus Pro → 🔒 Transpose, filtering, selection & export are Pro (search & sort are free) — start a free trial, or try them free on our showcase →
FcRn inhibitor
BAFF/APRIL inhibitor
Anti-BAFF-R (mAb)
Anti-CD40L
TYK2
Novartis
Amgen
argenx
🇨🇳Beijing InnoCare Pharma Tech
Bristol-Myers Squibb
Immunovant Sciences
🇨🇳Innovent Biologics (Suzhou)
Johnson & Johnson
Otsuka Pharmaceutical Develop…
🇨🇳Shanghai Escugen
Vor Biopharma

Phase 3 leaders · most advanced

  1. recruiting Vor Biopharma NCT07404865
  2. recruiting Amgen NCT06747949
  3. active Bristol-Myers Squibb NCT05946941
  4. active Novartis Pharmaceuticals NCT05349214
  5. active Amgen NCT06245408

Beyond the grid Beta

What the matrix leaves out — rare mechanisms with only one player, small & emerging sponsors, and programs we haven’t classified yet.

Single-company mechanisms — BD white space 2 found

Mechanisms only ONE company is pursuing in this indication — the uncrowded / first-in-class bets the matrix cap hides. ⚡ first-in-class · ⚠ unverified mechanism. ⚡ first-in-class is computed across 63 mapped landscapes — scope-limited, not a global claim.
⚡ first-in-class · 🌱 first-in-indication · 🆕 NME candidate · ✅ AI-classified + verified · ⚙️ AI-classified, unverified · first-in-class computed across 63 mapped landscapes
Single-program mechanisms (5) — one program each — earliest-stage, sorted by phase
PhaseMechanismCompanyModalityReadoutTrial
Ph1+Ph2 CD19 CAR-T (MS) 🌱 🆕 Novartis 4Q28 NCT07048197
Ph2 PRG4 ⚡ 🌱 🆕 Lubris Bio 3Q26 NCT07118241
Ph1 BCMA × CD3 bispecific 🌱 🆕 Keymed 2Q28 NCT07642843
Ph1 CD19 🌱 🆕 Chongqing Precision Cell therapy 4Q25 NCT06056921
Ph1 CD19 × CD3 T-cell engager 🌱 🆕 Cullinan SC 1Q28 NCT07041099
Unclassified programs (5) — mechanism not captured yet
PhaseMechanismCompanyModalityReadoutTrial
Ph2 Allogeneic NK Cellsunclassified Artiva Biotherapeutics, I… NCT06991114
Ph2 RSLV-132, Placebounclassified Resolve Therapeutics NCT06440525
Ph2 DDY391, Placebounclassified Novartis Pharmaceuticals NCT07737743
Ph2 ONO-4915, Placebounclassified Ono Pharmaceutical Co., L… NCT07823790
Ph1 R-2487unclassified Rise Therapeutics LLC NCT06297213

Sponsor activity

Who is running trials now — green active, blue completed, red failed/terminated.

Sorted by active Active Done Failed
Bristol-Myers Squibb 3 1 2
Novartis 2 8 3
Amgen 2 3 1
China Immunotech (Beijing) Biotechnology Co., Ltd. 2 0 0
argenx 1 2 0
Lubris Bio Pty Ltd 1 0 1
Innovent Biologics (Suzhou) Co. Ltd. 1 1 0
Resolve Therapeutics 1 1 0
Xencor, Inc. 1 0 0
Immunovant Sciences GmbH 1 0 0
Vor Biopharma 1 0 0
Cullinan Therapeutics Inc. 1 0 0
Therorna 1 0 0
Shanghai Escugen Biotechnology Co., Ltd 1 0 0
Artiva Biotherapeutics, Inc. 1 0 0

All 15 active Sjogren's Disease sponsors

Unlock the remaining 7 sponsors with active / completed / failed counts — sortable and exportable.

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How the field has grown

New-trial starts peaked in 2026 (26 registered); 2025 saw 16. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (16 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.

New trials started by year

2016
6
2017
5
2018
5
2019
9
2020
7
2021
12
2022
8
2023
7
2024
16
2025
16
2026
26

TheraRadar.com

Median Phase 3 enrollment by start year

2016 (0)
0
2017 (0)
0
2018 (1)
60
2019 (2)
31
2020 (0)
0
2021 (3)
100
2022 (2)
391
2023 (2)
578
2024 (3)
434
2025 (1)
844
2026 (2)
1,275

TheraRadar.com

Full trial pipeline

Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.

NCT07404865 RECRUITING
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
Vor Biopharma n=250
NCT06747949 RECRUITING
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
Amgen n=844
NCT05946941 ACTIVE NOT RECRUITING
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
Bristol-Myers Squibb n=774
NCT05349214 ACTIVE NOT RECRUITING
Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
Novartis Pharmaceuticals n=506
NCT06245408 ACTIVE NOT RECRUITING
A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
Amgen n=434
NCT07791199 NOT YET RECRUITING
Continued Access to Deucravacitinib for Adult SLE/SjD and Pediatric PsO/PsA Study Completers
Bristol-Myers Squibb n=2,300
NCT05350072 COMPLETED
Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
Novartis Pharmaceuticals n=275
NCT01782235 COMPLETED
Efficacy of Tocilizumab in Primary Sjögren's Syndrome.
University Hospital, Strasbourg, France n=110
NCT06104124 COMPLETED
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
Amgen n=651
NCT05673993 COMPLETED
A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome
RemeGen Co., Ltd. n=381
NCT03700138 COMPLETED
Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies
University Hospital, Strasbourg, France n=24
NCT06931041 COMPLETED
Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye.
Instituto de Oftalmología Fundación Conde de Valenciana n=25
NCT00740948 COMPLETED
Tolerance and Efficacy of Rituximab in Sjogren's Disease
University Hospital, Brest n=122
NCT05005806 COMPLETED
Fish Oil (Omega 3 ) in Sjogren's Syndrome
Hawler Medical University n=100
NCT04819269 COMPLETED
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
Sylentis, S.A. n=203
NCT04252209 COMPLETED
the Effect of Mixture of Natural Products As Salivary Substitutes in Treatment Of Xerostomia
Cairo University n=24
NCT05598242 COMPLETED
Amniotic Membrane Treatment for Hyposecretory Dry Eye
Hospital Nacional Profesor Alejandro Posadas n=37
NCT04563195 WITHDRAWN
BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome
Matthew C. Baker
NCT02257957 COMPLETED
Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Universidad Nacional de Colombia n=30
NCT02067910 COMPLETED
Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome
University Medical Center Groningen n=80
NCT03865888 COMPLETED
Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome
Pavly Moawd n=60
NCT01601028 COMPLETED
Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
Seoul National University Hospital n=39
NCT00632866 COMPLETED
Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome
Assistance Publique - Hôpitaux de Paris n=120

Full Sjogren's Disease Pipeline

Every trial across Phase 1–4, plus enrollment analytics. Sortable, filterable, exportable.

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Related TheraRadar briefs

In-depth analysis connected to Sjogren's Disease.

Frequently asked

Common questions about the Sjogren's Disease landscape

How many companies are developing Sjögren's Disease treatments?
11 companies have active or registered Sjögren's Disease programs in TheraRadar's competitive landscape (20 classified trials). The most active are Novartis, Amgen, and argenx.
What mechanisms of action are being developed for Sjögren's Disease?
5 distinct mechanisms of action appear across the Sjögren's Disease pipeline, including FcRn inhibitor, BAFF/APRIL inhibitor, Anti-BAFF-R (mAb), Anti-CD40L, and TYK2.
What is the most crowded mechanism in Sjögren's Disease?
FcRn inhibitor is the most contested mechanism in Sjögren's Disease, with 4 programs mapped to it.
Are there upcoming Sjögren's Disease clinical readouts or FDA decisions?
Near-term Sjögren's Disease catalysts include Deucravacitinib (data readout, Nov '26); Sibeprenlimab (data readout, Mar '27); Efgartigimod PH20 SC (data readout, Jul '27). Dates combine estimated trial primary-completion readouts and confirmed FDA decision dates.
Where does TheraRadar's Sjögren's Disease landscape data come from?
Programs are derived from industry-sponsored ClinicalTrials.gov registrations (2008–present) and classified by mechanism of action using a curated rule set plus an LLM pipeline. Every cell links to its underlying trials, so each program is verifiable.
Is the Sjögren's Disease heatmap free to use?
Yes — viewing and searching the Sjögren's Disease heatmap is free. A TheraRadar Pro subscription adds advanced filters, row/column selection, and one-click export to PowerPoint, PDF, and CSV.
How this is built — methodology & limits

These grids are only as good as the data and the classification behind them — so here is exactly what goes in, what stays out, how every assignment is made, and where the limits are.

Where the data comes from

Every heatmap is built from the public ClinicalTrials.gov registry, via its official API — interventional drug and biologic trials with a start date of 2008 or later. The master index holds over 145,000 trials and is refreshed weekly (see the “updated” date on this page). A disease landscape draws only from the active, Phase 1–3, industry-sponsored slice of that index.

  • In scope: industry-sponsored trials in Phase 1, 2, or 3, with an active status (recruiting, active-not-recruiting, not-yet-recruiting, or enrolling by invitation). Phase 4 sits in the index but is left out of the landscapes.
  • Filtered out: deeply stale programs (a primary completion date more than two years past with no update to completed or terminated); basket trials and incidental mentions (a trial counts toward a disease only when that disease is genuinely the subject of study — not a secondary cohort, an organ-of-origin overlap, or a passing mention); and healthy-volunteer studies.

We do not exclude trials by sponsor geography. Where a sponsor is based in China, the program is flagged on the page rather than hidden, so you can weigh it yourself. An automated test fails the weekly refresh if the underlying index is more than 14 days old, so a published grid is never built on a stale index.

How a trial is matched to a disease

Matching uses a structured medical ontology, not keyword guessing, and is designed so that no trial is ever silently dropped — every trial that clears the filters gets a classification, even if that is just “Other.” It runs as an ordered sequence of steps, stopping at the first that applies:

  1. Healthy-volunteer studies are set aside as non-disease trials.
  2. Ontology match — each tracked disease is linked to its official identifiers in the standard medical taxonomy (MeSH), so a trial can be matched even when its text uses a synonym.
  3. Curated disease patterns — a hand-maintained library of over 150 disease-name patterns covers the more granular indications across oncology, hematology, infectious disease, cardiometabolic, immunology, and neuropsychiatry.
  4. Basket guard — a trial matching four or more distinct diseases, or carrying explicit basket language (“tumor-agnostic,” “all solid tumors,” “pan-cancer”), is grouped into a single advanced-solid-tumor category rather than over-counted across every cancer it touches.
  5. Therapeutic-area roll-up — a trial with no specific match, but which the taxonomy still places under a broad area, is assigned to that area (“Oncology — other,” “Immunology — other,” …), checking cancers first so a site-specific tumor isn’t filed under its anatomical system.

A “drop-if-parent-present” rule keeps a generic name from drowning out a subtype: a trial matching both lupus and lupus nephritis is reported only as lupus nephritis. Internal abbreviations are translated to the plain disease names used across the site (for example, “CRC” becomes “Colorectal Cancer”), and the same classifier is shared by every heatmap, so the same trial always maps to the same disease wherever it appears.

How a drug is matched to its mechanism

Mechanism of action is the hardest part to get right, so it is assigned in layers — leaning on curated and public data first, with AI as a last resort:

  1. Curated rulebook (first). A rulebook we maintain — over 600 drug-to-mechanism rules — is checked first, matching on drug names, trial acronyms, sponsor trial identifiers, and intervention lists. First match wins, which stops a combination trial from being counted several times.
  2. Public molecular-target data. Where no rule applies, each intervention’s target is looked up in a public target database, with verbose or gene-symbol labels normalized into consistent short forms so one target isn’t split across several columns.
  3. Standard-of-care backbones. A small set of rules recognizes common combination scaffolds (checkpoint-inhibitor monotherapy, standard chemotherapy regimens, established standard-of-care agents) so they aren’t mistaken for the experimental arm.
  4. AI as a last resort, then cross-checked. Only for genuinely opaque sponsor code-names that none of the first three steps can resolve do we ask an AI model to propose a mechanism — applied only above a fixed confidence bar, then automatically cross-checked against the sponsor’s own pipeline page. Where AI and the sponsor agree, the program is marked sponsor-verified. Where they contradict, the label is discarded entirely — not shown, not counted.

New mechanism rules are independently double-verified before they’re trusted — a second, adversarial pass set up to disprove the first — and each is checked so it can’t mislabel an unrelated trial. Drugs whose mechanism isn’t publicly disclosed are shown openly as “Emerging — not yet disclosed” rather than guessed at: for a tool meant to support real decisions, “we don’t yet know” is a more trustworthy answer than a confident guess.

Where AI is used — and where it isn’t

The disease and mechanism matching above is driven first by deterministic rules and public ontologies, not AI. AI plays three bounded, disclosed roles: (1) an optional extra check that a trial genuinely studies the disease, on top of the ontology match; (2) inferring a trial’s treatment setting on the competitive grids when the rules don’t cover it, only above a fixed confidence bar; and (3) the last-resort mechanism step above, always cross-checked against the sponsor’s disclosures. Wherever an AI label reaches a cell, the page marks it (⚙️ or ✅) — AI is never the silent, sole source of what you see.

What the on-page markers mean

  • ✅ Sponsor-verified — AI proposed the mechanism and it matched the sponsor’s own pipeline page. High-trust.
  • ⚙️ AI-classified — AI proposed it above the confidence bar but it has not yet been cross-checked against the sponsor. Useful; verify before citing. It never means a person reviewed it.
  • ⚡ First-in-class — the mechanism hasn’t appeared in any other disease landscape we’ve built. This reflects the scope of landscapes published so far (the tooltip lists exactly which were scanned), not an absolute claim about the whole market.
  • 🌱 First-in-indication — the only program competing on that mechanism within this disease.
  • 🆕 NME candidate — the interventions match no drug in our approved-drug index, suggesting a new molecular entity. The index is incomplete — a signal, not a regulatory fact.
  • 🔗 Combination · 👶 Pediatric · 🔥 Hot (readout within six months) · ⏳ Stale (completion date passed but still marked active — often a stalled program).

Sponsor names are resolved through a curated parent/subsidiary map; unrecognized sponsors appear under their raw registry name. The registry records the sponsor at a trial’s inception, so names are as originally filed and may not reflect later acquisitions. To keep large grids legible, mechanisms with a single program are listed separately rather than crowding the main grid, and very small players are listed below it — presentation choices only; nothing is removed from the underlying counts.

How we score programs — “what’s about to move”

Each program carries a 0–100 score that deliberately ranks imminence over raw stage — the most decision-relevant signal on a competitive grid. It is the sum of:

  • Clinical phase — up to 40 points (Phase 3 = 40, Phase 2 = 25, Phase 1 = 10).
  • Readout proximity — up to 60 points (next readout <6 months = 60, 6–12 months = 45, 1–2 years = 30, distant = 5).
  • Stale penalty — the score is halved if a trial is past its expected readout but still listed as active.

Cell colour on the grid is driven by this score, so a Phase 2 program about to read out can — correctly — outrank a dormant Phase 3 one. It answers “what’s about to move,” not just “what’s furthest along.”

What each grid plots

  • Indication landscape (this page) — one disease — companies (rows) × mechanism of action (columns): who is competing, and on what mechanism.
  • Company portfolio — one company — diseases (rows) × mechanism (columns): where it is active, and what it is betting on.
  • MOA platform — one mechanism family — drugs (rows) × diseases (columns): who is working on this class, and where.
  • Competitive landscape — one disease — mechanism (rows) × clinical setting (columns), aggregated across companies; setting columns are tailored per disease (e.g. lines of therapy in oncology; biologic-naïve vs. biologic-experienced in IBD).

What we don’t claim

  • First-in-class is editorial, not absolute — “not seen in the landscapes we’ve built,” not “novel across the industry.”
  • NME candidate is a signal, not a filing — absent from our (incomplete) approved-drug index.
  • Disease matching is automated and not exhaustively validated per disease — ontology and pattern matching can occasionally include or miss a trial.
  • AI-classified mechanisms are machine-proposed — unconfirmed unless they also carry ✅.
  • Sponsor names are as-filed and may lag current ownership.
  • Grids are as fresh as their last rebuild from the weekly index — no faster continuous refresh is claimed.

Data: ClinicalTrials.gov v2 API + FDA Drugs@FDA (approved-drug index). Spot an error? hello@theraradar.com.

Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only