Myasthenia Gravis Clinical Trial Landscape
Generalized myasthenia gravis is an autoantibody-driven disorder of the neuromuscular junction, where antibodies against the acetylcholine receptor (and in subsets MuSK or LRP4) disrupt nerve-to-muscle signaling and produce fatigable weakness. Care was historically built on acetylcholinesterase inhibitors for symptom relief layered over broad, nonspecific immunosuppression — corticosteroids, azathioprine and similar agents — with IVIG, plasma exchange and thymectomy reserved for refractory or crisis settings.
The modern shift has been toward mechanism-targeted antibody clearance: FcRn blockers efgartigimod (Vyvgart), rozanolixizumab (Rystiggo) and nipocalimab, alongside complement C5 inhibitors eculizumab, ravulizumab and zilucoplan, are now approved options. The field is now extending past IgG depletion and complement into B-cell-directed approaches.
Trial activity
Competitive Intelligence
This Myasthenia Gravis competitive landscape maps 15 companies against 5 mechanisms of action (MOA) across 16 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 Myasthenia Gravis, across a row to see one company's mechanistic spread, and click any cell for the full program list and trial links.
Myasthenia gravis has matured into a two-horse race at the front, with UCB and argenx pushing their most advanced assets toward readout while FcRn blockers and complement C5 inhibitors anchor an already-crowded approved field. The real frontier is cellular: BCMA and CD19 CAR-T programs, alongside BAFF/APRIL agents, are testing whether autoimmune MG can be reset rather than chronically suppressed. Up top the field is consolidating around proven mechanisms even as newer entrants probe for differentiation downstream.
- 16 companies span 47 programs, 39 of them with a defined mechanism; UCB (7 programs) and argenx (6) together account for 67% of the leading assets.
- FcRn inhibitors lead the mechanism mix with 14 programs, ahead of complement C5 inhibitors at 8; cell therapies follow with 4 BCMA CAR-T and 3 CD19 CAR-T, alongside 3 BAFF/APRIL agents.
- Approved options already span both anchor classes: FcRn blockers Vyvgart/efgartigimod, Rystiggo/rozanolixizumab and nipocalimab, plus complement C5 agents eculizumab, ravulizumab and zilucoplan.
- The pipeline includes 2 new molecular entities and a 7-program long tail; the most novel entrant is NMD Pharma's ClC-1 chloride channel inhibitor (Ph2), while UCB's complement C5 program RAISE-XT is nearest to readout.
Forward catalysts next 18 months⏰ 2 due ≤6 mo
primaryCompletionDate — a timing proxy, not a confirmed action date). Red = due within 6 months.Company × Mechanism
FcRn inhibitor | Complement C5 inhibitor | BCMA CAR-T (autoimmune) | BAFF/APRIL inhibitor | CD19 CAR-T (autoimmune) | |
|---|---|---|---|---|---|
| UCB | |||||
| argenx | |||||
| AstraZeneca | |||||
| Cartesian | |||||
| Immunovant Sciences | |||||
| Johnson & Johnson | |||||
| Arcellx | |||||
| Cabaletta Bio | |||||
| CSPC ZhongQi Pharmaceutical T… | |||||
| ImmunAbs | |||||
| Regeneron | |||||
| 🇨🇳RemeGen | |||||
| 🇨🇳Shenzhen MagicRNA | |||||
| Vertex Pharmaceuticals Incorp… | |||||
| Vor Biopharma |
Phase 3 leaders · most advanced
- recruiting Novartis Pharmaceuticals NCT06744920
- recruiting Novartis Pharmaceuticals NCT06517758
- recruiting Immunovant Sciences GmbH NCT07039916
- recruiting Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany NCT06463587
- active Amgen NCT04524273
Beyond the grid Beta
Single-program mechanisms (7) — one program each — earliest-stage, sorted by phase
| Phase | Mechanism | Company | Modality | Readout | Trial |
|---|---|---|---|---|---|
| Ph3 | BTK (CNS-penetrant) 🌱 | Novartis | Oral | 1Q28 | NCT06744920 |
| Ph2+Ph3 | CD19 CAR-T 🌱 🆕 | Kyverna | Cell therapy | 3Q27 | NCT06193889 |
| Ph3 | Cladribine ⚡ 🌱 | Merck Healthcare KGaA, Da… | Oral | 3Q28 | NCT06463587 |
| Ph3 | Complement Factor B/D inhibitor 🌱 | Novartis | 2Q27 | NCT06517758 | |
| Ph2 | Anti-CD19 mAb (NMOSD/MS) 🌱 | Amgen | 1Q30 | NCT06987539 | |
| Ph2 | ClC-1 chloride channel inhibitor ⚡ 🌱 🆕 | NMD Pharma A/S | ⏰ 2Q26 | NCT06414954 | |
| Ph1 | IgE 🌱 🆕 | Candid | 4Q27 | NCT07215650 |
Unclassified programs (12) — mechanism not captured yet
| Phase | Mechanism | Company | Modality | Readout | Trial |
|---|---|---|---|---|---|
| Ph2+Ph3 | B007, Placebounclassified | Shanghai Jiaolian Drug Re… | NCT06447597 | ||
| Ph3 | Safety and Efficacy of ALXN1720 in Adults With Generalized Myas…unclassified | Alexion Pharmaceuticals, … | NCT05556096 | ||
| Ph3 | PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric …unclassified | Alexion Pharmaceuticals, … | NCT06607627 | ||
| Ph3 | A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC i…unclassified | argenx | NCT06558279 | ||
| Ph2 | Efgartigimod IV, Empasiprubart IVunclassified | argenx | NCT07284420 | ||
| Ph1+Ph2 | Aritinerceptunclassified | Aurinia Pharmaceuticals I… | NCT07596901 | ||
| Ph1+Ph2 | Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB3…unclassified | Novartis Pharmaceuticals | NCT06704269 | ||
| Ph2 | DNTH103, Placebounclassified | Dianthus Therapeutics | NCT06282159 | ||
| Ph1+Ph2 | CNP-106unclassified | COUR Pharmaceutical Devel… | NCT06106672 | ||
| Ph1 | Azercabtagene zapreleucel (azer-cel)unclassified | TG Therapeutics, Inc. | NCT06680037 | ||
| Ph1 | KITE-363, Fludarabine, Cyclophosphamideunclassified | Kite, A Gilead Company | NCT07304154 | ||
| Ph1 | CC-97540, Fludarabine, Cyclophosphamideunclassified | Juno Therapeutics, Inc., … | NCT06220201 |
Sponsor activity
Who is running trials now — green active, blue completed, red failed/terminated.
How the field has grown
New-trial starts peaked in 2024 (25 registered); 2025 saw 21. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (59 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 Myasthenia Gravis landscape
- How many companies are developing Myasthenia Gravis treatments?
- 15 companies have active or registered Myasthenia Gravis programs in TheraRadar's competitive landscape (35 classified trials). The most active are UCB, argenx, and AstraZeneca.
- What mechanisms of action are being developed for Myasthenia Gravis?
- 5 distinct mechanisms of action appear across the Myasthenia Gravis pipeline, including FcRn inhibitor, Complement C5 inhibitor, BCMA CAR-T (autoimmune), BAFF/APRIL inhibitor, and CD19 CAR-T (autoimmune).
- What is the most crowded mechanism in Myasthenia Gravis?
- FcRn inhibitor is the most contested mechanism in Myasthenia Gravis, with 12 programs mapped to it.
- Are there upcoming Myasthenia Gravis clinical readouts or FDA decisions?
- Near-term Myasthenia Gravis catalysts include Efgartigimod PH20 SC (data readout, Sep '26); Decartes-08 (data readout, Nov '26); Telitacicept (data readout, Dec '26). Dates combine estimated trial primary-completion readouts and confirmed FDA decision dates.
- Where does TheraRadar's Myasthenia Gravis 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 Myasthenia Gravis heatmap free to use?
- Yes — viewing and searching the Myasthenia Gravis 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