Lupus Clinical Trial Landscape
Systemic lupus erythematosus is a chronic, multi-organ autoimmune disease driven by autoantibodies, type-I interferon signaling, and B-cell dysregulation, with a relapsing-remitting course that has long been managed with corticosteroids, antimalarials such as hydroxychloroquine, and broad immunosuppression. For decades the field saw little targeted innovation, and clinical development was notorious for trial failures against a heterogeneous disease and a high placebo response.
That changed with the arrival of the anti-BLyS antibody belimumab (Benlysta) and, more recently, the type-I interferon receptor blocker anifrolumab (Saphnelo) — the first mechanism-specific biologics in the indication. The field has since shifted from broad immunosuppression toward selectively resetting the B-cell and interferon axes that underlie the disease.
Trial activity
Competitive Intelligence
This Lupus competitive landscape maps 18 companies against 14 mechanisms of action (MOA) across 24 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 Lupus, across a row to see one company's mechanistic spread, and click any cell for the full program list and trial links.
Lupus has finally moved past a long approval drought: belimumab and anifrolumab established the BLyS and type-I interferon franchises, and the action has now swung decisively toward cell therapy, with autologous CD19 CAR-T emerging as the single most-contested approach in the pipeline. The field is broadening rather than consolidating — a wave of T-cell engagers and BAFF/APRIL agents is crowding in behind the cell therapies, while a separate cohort led by Biogen and Viatris is betting on fewer but more advanced lead assets. Where the approved drugs damp down immune signaling, the frontier is increasingly about depleting or re-engaging the B cells driving the disease.
- 155 total programs (125 mapped to a mechanism) across 8 companies; the 3 leading sponsors hold a combined 31% share.
- CD19 CAR-T leads the pipeline with 26 programs, far ahead of the next mechanisms: BAFF/APRIL inhibitors (7), and anti-BDCA2, anti-IFNAR1 and CD19×CD3 T-cell engagers (6 each).
- 18 are new molecular entities; mechanism breadth spans 9 approved-class and 11 pre-approval mechanisms, with a 24-program long tail.
- Top sponsors by program count: Novartis (9), Bristol-Myers Squibb (7), AstraZeneca (6); most novel asset is Zenas BioPharma's anti-CD19 × FcγRIIb (Phase 2).
Forward catalysts next 18 months⏰ 6 due ≤6 mo
primaryCompletionDate — a timing proxy, not a confirmed action date). Red = due within 6 months.Company × Mechanism
CD19 CAR-T (autoimmune) | Anti-BDCA2 (mAb) | BAFF/APRIL inhibitor | CD19 CAR-T (MS) | TYK2 | Anti-IFNAR1 (type-I IFN) | S1P modulator | TLR7/8 antagonist | Anti-CD38 (mAb) | CD19 × CD3 T-cell engager | CD19 ADC (GRM payload) | Anti-CD20 (mAb) | Anti-CD19 (mAb) | BCMA CAR-T (autoimmune) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | ||||||||||||||
| Bristol-Myers Squibb | ||||||||||||||
| 🇨🇳China Immunotech (Beijing) | ||||||||||||||
| Biogen | ||||||||||||||
| AstraZeneca | ||||||||||||||
| Chongqing Precision | ||||||||||||||
| Viatris Innovation | ||||||||||||||
| AbbVie | ||||||||||||||
| Autolus Limited | ||||||||||||||
| 🇨🇳Beijing Mabworks | ||||||||||||||
| Climb Bio | ||||||||||||||
| EMD Serono Research & Develop… | ||||||||||||||
| Fate | ||||||||||||||
| 🇨🇳Hangzhou Sumgen | ||||||||||||||
| 🇨🇳Shenzhen MagicRNA | ||||||||||||||
| 🇨🇳Beijing InnoCare Pharma Tech | ||||||||||||||
| 🇨🇳Genrix (Shanghai) Biopharmace… | ||||||||||||||
| 🇨🇳Sinocelltech |
Phase 3 leaders · most advanced
- recruiting EMD Serono Research & Development Institute, Inc. NCT07355218
- recruiting EMD Serono Research & Development Institute, Inc. NCT07332481
- recruiting Janssen Research & Development, LLC NCT07438496
- active Viatris Innovation GmbH NCT05648500
- recruiting AstraZeneca NCT05835310
Beyond the grid Beta
Single-company mechanisms — BD white space 7 found
Single-program mechanisms (32) — one program each — earliest-stage, sorted by phase
| Phase | Mechanism | Company | Modality | Readout | Trial |
|---|---|---|---|---|---|
| Ph3 | Anti-CD40L ⚡ 🌱 🆕 | UCB | 3Q30 | NCT04976322 | |
| Ph3 | CD40LG ⚡ 🌱 🆕 | UCB | 2Q28 | NCT06617325 | |
| Ph3 | IFNAR1 ⚡ 🌱 | AstraZeneca | SC | 3Q25 | NCT04877691 |
| Ph3 | JAK1 selective 🌱 | AbbVie | Oral | 1Q27 | NCT05843643 |
| Ph2 | Anti-BAFF-R (mAb) ⚡ 🌱 🆕 | Novartis | SC | 1Q26 | NCT06293365 |
| Ph2 | Anti-CD19 × FcγRIIb 🌱 🆕 | Zenas BioPharma (USA) | ⏰ 2Q26 | NCT06559163 | |
| Ph2 | Anti-CD19 mAb (NMOSD/MS) 🌱 | Amgen | IV | 3Q28 | NCT06570798 |
| Ph2 | Anti-CD40L (Sanofi) 🌱 🆕 | Sanofi | ⏰ 3Q26 | NCT05039840 | |
| Ph1+Ph2 | BCL-2 inhibitor 🌱 🆕 | Ascentage Pharma Group | 2Q26 | NCT06182969 | |
| Ph1+Ph2 | BCMA × CD3 bispecific 🌱 🆕 | Genrix (Shanghai) Biophar… | 2Q27 | NCT07348055 | |
| Ph2 | BTK inhibitor 🌱 🆕 | Beijing InnoCare Pharma T… | 3Q25 | NCT05688696 | |
| Ph1+Ph2 | CD20 × CD3 bispecific ⚡ 🌱 🆕 | Sinocelltech | 2Q27 | NCT06841042 | |
| Ph1+Ph2 | CD20/BCMA CAR-T (autoimmune) 🌱 🆕 | AbelZeta | Cell therapy | 2Q29 | NCT06935474 |
| Ph2 | cGAS inhibitor ⚡ 🌱 🆕 | Ventus Therapeutics U.S. | ⏰ 3Q26 | NCT07260877 | |
| Ph2 | Complement C5 / Factor H inhibitor 🌱 🆕 | Kira Pharmacenticals (US)… | 1Q26 | NCT05504187 | |
| Ph2 | Complement Factor B/D inhibitor 🌱 🆕 | Novartis | 1Q26 | NCT05268289 | |
| Ph1+Ph2 | Glucocorticoid receptor agonist 🌱 | DualityBio | 2Q27 | NCT06625671 | |
| Ph1+Ph2 | Opioid receptors 🌱 | Truway Health | 4Q34 | NCT07221565 | |
| Ph2 | T cell surface glycoprotein CD3 🌱 | Roche / Genentech | IV | 1Q28 | NCT07598396 |
| Ph1 | Anti-BDCA2 / TACI bispecific ⚡ 🌱 🆕 | Nanjing Leads Biolabs | 4Q27 | NCT07323173 | |
| Ph1 | Anti-ILT7 (pDC depletion) ⚡ 🌱 🆕 | Kyowa Kirin | 4Q24 | NCT05411016 | |
| Ph1 | BCMA × CD3 (TCE) 🌱 🆕 | Candid | 4Q27 | NCT07215663 | |
| Ph1 | BCMA/GPRC5D T-cell engager 🌱 🆕 | Qilu | ⏰ 4Q26 | NCT07001839 | |
| Ph1 | CAR-T ⚡ 🌱 🆕 | Hangzhou Qihan | Cell therapy | 4Q28 | NCT07444307 |
| Ph1 | CAR-T (autoimmune) ⚡ 🌱 🆕 | Nanjing Legend | 1Q28 | NCT07331272 | |
| Ph1 | CD19 CAR-NK (autoimmune) 🌱 🆕 | Ruitherapeutics | 3Q27 | NCT07358988 | |
| Ph1 | CD19/CD20 bispecific (mAb) 🌱 🆕 | Hinge Bio | 4Q27 | NCT07491900 | |
| Ph1 | Engineered IL-2 ⚡ 🌱 🆕 | Otsuka Pharmaceutical Dev… | ⏰ 4Q26 | NCT06799520 | |
| Ph1 | FCGRH3 🌱 🆕 | Roche / Genentech | IV | 1Q30 | NCT07629583 |
| Ph1 | IL-2 🌱 | Century | 3Q28 | NCT06255028 | |
| Ph1 | Mesenchymal stem cell 🌱 🆕 | LiveKidney.Bio | Cell therapy | ⏰ 2Q26 | NCT06737380 |
| Ph1 | Undisclosed target 🌱 🆕 | Eli Lilly | 1Q28 | NCT07276958 |
Emerging & small-cap sponsors (31) — few programs here — partnering / M&A radar
| Phase | Mechanism | Company | Modality | Readout | Trial |
|---|---|---|---|---|---|
| Ph2 | TYK2 | Alumis | ⏰ 3Q26 | NCT05966480 | |
| Ph1+Ph2 | 🇨🇳 CD19 CAR-T | Beijing | IV | 1Q27 | NCT07523542 |
| Ph1 | 🇨🇳 CD19 CAR-T (autoimmune) | Beijing Immunochina Medic… | 1Q26 | NCT06852573 | |
| Ph1+Ph2 | CD19 CAR-T (autoimmune) | Cabaletta Bio | 4Q29 | NCT06121297 | |
| Ph1 | CD19 CAR-T (autoimmune) | Capstan | IV | 4Q27 | NCT06917742 |
| Ph2 | BCMA CAR-T (autoimmune) | Cartesian | ⏰ 4Q26 | NCT06038474 | |
| Ph1 | CD19 CAR-T (autoimmune) | CRISPR | 4Q31 | NCT06925542 | |
| Ph1 | BCMA CAR-T (autoimmune) | CSPC ZhongQi Pharmaceutic… | 1Q29 | NCT06694298 | |
| Ph1 | CD19 × CD3 T-cell engager | Cullinan | SC | ⏰ 4Q26 | NCT06613360 |
| Ph1+Ph2 | CD19 CAR-T (autoimmune) | Curocell | 2Q30 | NCT07364396 | |
| Ph1 | CD19 × CD3 T-cell engager | CytoCares | 3Q27 | NCT07177911 | |
| Ph2 | TLR7/8 antagonist ⚡ | Eisai | 3Q28 | NCT07515014 | |
| Ph1+Ph2 | CD19 × CD3 T-cell engager | Excyte Biopharma | 2Q27 | NCT07010835 | |
| Ph1 | BAFF/APRIL inhibitor | GSK | 1Q28 | NCT06576271 | |
| Ph1 | 🇨🇳 CD19 CAR-T (autoimmune) | Guangdong Ruishun | ⏰ 4Q26 | NCT06340490 | |
| Ph1 | Anti-CD38 (mAb) | HI-Bio, A Biogen Company | ⏰ 2Q26 | NCT06064929 | |
| Ph2 | FcRn inhibitor | Immunovant Sciences | ⏰ 4Q26 | NCT06980805 | |
| Ph3 | FcRn inhibitor | Johnson & Johnson | 4Q28 | NCT07438496 | |
| Ph2 | Anti-CD38 (mAb) | Keymed | ⏰ 4Q26 | NCT06791772 | |
| Ph1+Ph2 | CD19 CAR-T | Kyverna | Cell therapy | 4Q28 | NCT06342960 |
| Ph1 | BAFF/APRIL inhibitor | Luminary | Cell therapy | ⏰ 2Q26 | NCT06340750 |
| Ph1 | CD19 × CD3 T-cell engager | Merck & Co. | 3Q29 | NCT07363590 | |
| Ph2 | TLR7/8 antagonist ⚡ | Merck Healthcare KGaA, Da… | 3Q28 | NCT05540327 | |
| Ph1+Ph2 | CD19 CAR-T | Miltenyi Biomedicine | Cell therapy | ⏰ 2Q26 | NCT06347718 |
| Ph1 | 🇨🇳 CD19 CAR-T (autoimmune) | Nanjing IASO | 2Q28 | NCT07109986 | |
| Ph1 | CD19 CAR-T (autoimmune) | Sana Biotechnology | 4Q27 | NCT06294236 | |
| Ph1 | 🇨🇳 Anti-CD19 (mAb) | Shanghai IASO | 3Q27 | NCT07483346 | |
| Ph1 | 🇨🇳 CD19 × CD3 T-cell engager | Sichuan Baili | 4Q27 | NCT06857214 | |
| Ph1+Ph2 | 🇨🇳 Anti-BDCA2 (mAb) ⚡ | Sunshine Guojian Pharmace… | 3Q28 | NCT07185269 | |
| Ph1 | CD19 CAR-T (autoimmune) | Therorna | ⏰ 2Q26 | NCT07413341 | |
| Ph2 | S1P modulator | Viatris | 4Q27 | NCT07266090 |
Unclassified programs (39) — mechanism not captured yet
| Phase | Mechanism | Company | Modality | Readout | Trial |
|---|---|---|---|---|---|
| Ph3 | A Phase III Study to Investigate the Efficacy and Safety of Ani…unclassified | AstraZeneca | NCT06015737 | ||
| Ph3 | Obinutuzumab, Placebo, Acetaminophen/Paracetamolunclassified | Hoffmann-La Roche | NCT04963296 | ||
| Ph1+Ph2 | AZD0120, Cyclophosphamide, Fludarabineunclassified | AstraZeneca | NCT06897930 | ||
| Ph2 | TQH3906 capsule, TQH3906 placebounclassified | Chia Tai Tianqing Pharmac… | NCT07509892 | ||
| Ph2 | SHR-2173 Injection, SHR-2173 Injection Placebounclassified | Guangdong Hengrui Pharmac… | NCT07299422 | ||
| Ph2 | Dihydroartemisinin tablets, Dihydroartemisinin tablets, Hydroxy…unclassified | Kunming Pharmaceuticals, … | NCT07557927 | ||
| Ph2 | BI 3000202, Placebounclassified | Boehringer Ingelheim | NCT07409181 | ||
| Ph2 | D-2570, D-2570 Placebounclassified | InventisBio Co., Ltd | NCT07311200 | ||
| Ph1+Ph2 | GC012F Injectionunclassified | Gracell Biotechnologies (… | NCT06530849 | ||
| Ph1+Ph2 | ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following cy…unclassified | iCell Gene Therapeutics | NCT07328581 | ||
| Ph1+Ph2 | MB-CART19.1unclassified | Miltenyi Biomedicine GmbH | NCT06189157 | ||
| Ph2 | Mesenchymal stem cells (MSC), Placebounclassified | Red de Terapia Celular | NCT03673748 | ||
| Ph1+Ph2 | hUC-MSCs treatment (low dose), hUC-MSCs treatment (medium dose)…unclassified | Shenzhen Beike Bio-Techno… | NCT07041801 | ||
| Ph2 | TQB3702 Tablets, TQB3702 Tablets+TQB3702 Placebo, TQB3702 Place…unclassified | Chia Tai Tianqing Pharmac… | NCT06859931 | ||
| Ph2 | A Study to Investigate Pharmacokinetics, Pharmacodynamics, and …unclassified | AstraZeneca | NCT07630714 | ||
| Ph1 | RO7507062, Tocilizumabunclassified | Hoffmann-La Roche | NCT05835986 | ||
| Ph1 | Fludarabine, Cyclophosphamide, Tocilizumabunclassified | Juno Therapeutics, Inc., … | NCT07115745 | ||
| Ph1 | AZD5492unclassified | AstraZeneca | NCT06916806 | ||
| Ph1 | P-CD19CD20-ALLO1 Cells, Cyclophosphamide, Fludarabineunclassified | Genentech, Inc. | NCT06984341 | ||
| Ph1 | Vonsetamig, Odronextamabunclassified | Regeneron Pharmaceuticals | NCT06975787 | ||
| Ph1 | ISH0613 for injection, Placebounclassified | SUNHO(China)BioPharmaceut… | NCT07516639 | ||
| Ph1 | Cyclophosphamide, Fludarabineunclassified | Allogene Therapeutics | NCT07085104 | ||
| Ph1 | KITE-363, Fludarabine, Cyclophosphamideunclassified | Kite, A Gilead Company | NCT07038447 | ||
| Ph1 | SAR448501unclassified | Sanofi | NCT06647069 | ||
| Ph1 | ADI-001, Fludarabine, Cyclophosphamideunclassified | Adicet Therapeutics | NCT06375993 | ||
| Ph1 | GSK5926371unclassified | GlaxoSmithKline | NCT07371468 | ||
| Ph1 | ACT100 Injection, Placebo for ACT100, ACT100 Injectionunclassified | Xiamen Amoytop Biotech Co… | NCT07408908 | ||
| Ph1 | PTOC1unclassified | Chongqing Precision Biote… | NCT07403097 | ||
| Ph1 | HC022, Placebounclassified | HC Biopharma Inc. | NCT07306585 | ||
| Ph1 | AB-101, Cyclophosphamide, Fludarabineunclassified | Artiva Biotherapeutics, I… | NCT06265220 | ||
| Ph1 | SYNCAR-001, STK-009unclassified | Synthekine | NCT06544330 | ||
| Ph1 | BCD-256, BCD-256, BCD-256unclassified | Biocad | NCT07136389 | ||
| Ph1 | Inaticabtagene autoleucel Injectionunclassified | Juventas Cell Therapy Ltd. | NCT06826430 | ||
| Ph1 | HC022, Placebounclassified | HC Biopharma Inc. | NCT06657703 | ||
| Ph1 | zamtocabtagene autoleucel, Cyclophosphamide, Fludarabineunclassified | Miltenyi Biomedicine GmbH | NCT06708845 | ||
| Ph1 | After preconditioning with chemotherapy, F01 will be evaluated.unclassified | Shanghai Simnova Biotechn… | NCT06468683 | ||
| Ph1 | ATHENA CAR-T, Fludarabine, Cyclophosphamideunclassified | EdiGene Inc. | NCT06373991 | ||
| Ph1 | Relma-celunclassified | Shanghai Ming Ju Biotechn… | NCT06297408 | ||
| Ph1 | HBM7020unclassified | Otsuka Pharmaceutical Dev… | NCT07649265 |
Sponsor activity
Who is running trials now — green active, blue completed, red failed/terminated.
How the field has grown
New-trial starts peaked in 2025 (74 registered). The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (49 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
TheraRadar.com
Median Phase 3 enrollment by start year
TheraRadar.com
Full trial pipeline
Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.
Frequently asked
Common questions about the Lupus landscape
- How many companies are developing Systemic Lupus Erythematosus treatments?
- 18 companies have active or registered Systemic Lupus Erythematosus programs in TheraRadar's competitive landscape (118 classified trials). The most active are Novartis, Bristol-Myers Squibb, and China Immunotech (Beijing).
- What mechanisms of action are being developed for Systemic Lupus Erythematosus?
- 14 distinct mechanisms of action appear across the Systemic Lupus Erythematosus pipeline, including CD19 CAR-T (autoimmune), Anti-BDCA2 (mAb), BAFF/APRIL inhibitor, CD19 CAR-T (MS), and TYK2.
- What is the most crowded mechanism in Systemic Lupus Erythematosus?
- CD19 CAR-T (autoimmune) is the most contested mechanism in Systemic Lupus Erythematosus, with 15 programs mapped to it.
- Are there upcoming Systemic Lupus Erythematosus clinical readouts or FDA decisions?
- Near-term Systemic Lupus Erythematosus catalysts include Afimetoran (data readout, Jun '26); CD19 CAR-T cells (data readout, Jul '26); BCMA/CD70 CAR-T cells (data readout, Jul '26). Dates combine estimated trial primary-completion readouts and confirmed FDA decision dates.
- Where does TheraRadar's Systemic Lupus Erythematosus 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 Systemic Lupus Erythematosus heatmap free to use?
- Yes — viewing and searching the Systemic Lupus Erythematosus 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:
- Healthy-volunteer studies are set aside as non-disease trials.
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- 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? [email protected].
Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only