Sanofi Drug Pipeline
124 active trials across 16 therapeutic areas
Sanofi maintains a substantial clinical portfolio, with 1106 trials registered since 2008 and 131 currently active. These active programs span a range of development phases, including 22 in Phase 1, 56 in Phase 2, 57 in Phase 3, and 13 in Phase 4. Sanofi’s research activity extends across 16 therapeutic areas, with a notable concentration in Oncology, which accounts for 8% of active programs. Within Oncology, Multiple Myeloma represents the largest focus, with 8 active trials, 3 of which are in Phase 3. Other key therapeutic areas include Immunology, Respiratory, and Rare Diseases, each with 9 or more active trials, as well as Metabolic and Infectious Diseases. The Phase 3 weighting suggests a pipeline with a number of near-term potential catalysts. Beyond Multiple Myeloma, other oncology indications being actively investigated include Solid Tumor (Advanced), Non-Hodgkin Lymphoma, and NSCLC.
Pipeline by indication × mechanism
Where Sanofi is active and what mechanism it is betting on — with forward catalysts, per-asset tearsheets, and export.
Sanofi’s pipeline maps to 33 classified programs across 19 indications and 16 mechanisms. The most contested mechanism is IL-33 (8 programs).
- Therapeutic-area concentration: 8 of 68 programs (12%) are in Immunology — other — primary focus area.
- Top mechanism: IL-33 (8 programs, 12%) — leading but diversified.
- 4 platform mechanisms deployed in ≥3 indications (top: IL-4Rα inhibitor in 4 indications, 6 programs) — modality reuse.
- 11 of 28 mechanisms are first-in-class within sibling-landscape scope (als, alzheimers, aml, atopic-dermatitis, bladder-cancer, breast-her2-low, breast-her2-positive, breast-hr-positive, breast-tnbc, breast, cd, cervical-cancer, crc-braf, crc-her2, crc-kras-g12c, crc-msi-h, crc, crswnp, csu, endometrial-cancer, gastric-cancer, glioblastoma, head-and-neck-cancer, hepatocellular-carcinoma, hidradenitis-suppurativa, iga-nephropathy, itp, lupus-nephritis, melanoma-adjuvant, melanoma-braf, melanoma-uveal, melanoma, mesothelioma, multiple-myeloma, multiple-sclerosis, myasthenia-gravis, nmosd, nsclc-1l-io, nsclc-adc, nsclc-alk, nsclc-egfr, nsclc-her2, nsclc-kras-g12c, nsclc-met, nsclc-ret, nsclc-ros1, nsclc, obesity, ovarian-cancer, parkinsons, pdac, prostate-hrr-parp, prostate-mcrpc, prostate-mcspc, prostate-nmcrpc, prostate, renal-cell-carcinoma, schizophrenia, sclc, sle, uc).
- 31 NME candidates (46% of pipeline) — investigational vs label-extension split.
- 7 pediatric programs (10%) — label-extension footprint.
- Phase distribution: 41 Ph3, 25 Ph2, 2 Ph1 — late-stage-heavy pipeline.
Forward catalysts next 18 months⏰ 3 due ≤6 mo
primaryCompletionDate — a timing proxy, not a confirmed action date). Red = due within 6 months.Indication × Mechanism
IL-33 | BTK inhibitor | IL-4Rα inhibitor | Anti-TNF / OX40L | Oral TNFR1 | TL1A | Antithrombin mRNA RNAi inhibitor | Anti-CD40L (Sanofi) | ROCK1 | Anti-CD38 (mAb) | Anti-IL-1R3 (IL1RAP) | GCS / GBA | T-cell surface glycoprotein CD3 e… | Streptococcus pneumoniae | RSV F protein | CALCINEURIN | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ImmunologyImmunology — other | ||||||||||||||||
| OtherOther | ||||||||||||||||
| ImmunologyUlcerative Colitis | ||||||||||||||||
| ImmunologyCrohn's Disease | ||||||||||||||||
| HematologyHematology — other | ||||||||||||||||
| RespiratoryRespiratory — other | ||||||||||||||||
| CNSMultiple Sclerosis | ||||||||||||||||
| RespiratoryAsthma | ||||||||||||||||
| RespiratoryChronic Rhinosinusitis with N… | ||||||||||||||||
| CNSCNS — other | ||||||||||||||||
| DermatologyDermatology — other | ||||||||||||||||
| ImmunologyImmune Thrombocytopenia | ||||||||||||||||
| MetabolicType 2 Diabetes | ||||||||||||||||
| ImmunologyHidradenitis Suppurativa | ||||||||||||||||
| OncologyOncology — other | ||||||||||||||||
| Infectious DiseasePneumococcal | ||||||||||||||||
| Infectious DiseaseInfluenza | ||||||||||||||||
| ImmunologyLupus | ||||||||||||||||
| Infectious DiseaseRSV |
Beyond the grid Beta
Niche mechanisms — run in a single indication 17 found
Unclassified programs (44) — mechanism not captured yet
| Phase | Mechanism | Company | Modality | Readout | Trial |
|---|---|---|---|---|---|
| Riliprubart, Placebo, Riliprubartunclassified | NCT06290128 | ||||
| frexalimab, brivekimig, rilzabrutinibunclassified | NCT06500702 | ||||
| Acne mRNA vaccineunclassified | NCT06316297 | ||||
| Amlitelimab, Topical corticosteroids, Topical calcineurin inhib…unclassified | NCT05492578 | ||||
| Itepekimab (SAR440340), Placebo, Mometasone furoate nasal spray…unclassified | NCT06691113 | ||||
| Isatuximab SAR650984, Bortezomib, Lenalidomideunclassified | NCT03319667 | ||||
| SAR446268unclassified | NCT06844214 | ||||
| Itepekimab (SAR440340), Placebo, Mometasone furoate nasal spray…unclassified | NCT06834347 | ||||
| Frexalimab, Frexalimab, Tacrolimusunclassified | NCT07412470 | ||||
| trivalent (RSV/hMPV/PIV3) vaccine candidate, trivalent (RSV/hMP…unclassified | NCT07295028 | ||||
| Itepekimab (SAR440340), Placebo, Mometasone furoate nasal spray…unclassified | NCT06834360 | ||||
| Riliprubart Prefilled Pen (PFP)unclassified | NCT06859099 | ||||
| Amlitelimabunclassified | NCT05769777 | ||||
| PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccineunclassified | NCT06736041 | ||||
| SAR446597, Sham Comparatorunclassified | NCT07215234 | ||||
| Amlitelimab, Placebounclassified | NCT06407934 | ||||
| PCV21, 20vPCVunclassified | NCT07247188 | ||||
| PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccineunclassified | NCT06824194 | ||||
| Frexalimab, Placebo, Insulinunclassified | NCT06111586 | ||||
| Chlamydia mRNA Vaccineunclassified | NCT06891417 | ||||
| SAR446523unclassified | NCT06630806 | ||||
| SAR448501unclassified | NCT06647069 | ||||
| Venglustat (GZ402671), Agalsidase alfa, Agalsidase beta (GZ4198…unclassified | NCT05280548 | ||||
| Amlitelimab, Placebounclassified | NCT06557772 | ||||
| BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg), Rituxim…unclassified | NCT05156710 | ||||
| SAR444336, Placebounclassified | NCT07156175 | ||||
| PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccineunclassified | NCT06824181 | ||||
| Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vacc…unclassified | NCT06647407 | ||||
| SAR445877, Cetuximab, ADG126unclassified | NCT05584670 | ||||
| Pandemic flu H5 HA mRNA SD2 vaccineunclassified | NCT06907511 | ||||
| Blood draw for the laboratory assessmentunclassified | NCT02065011 | ||||
| Isatuximab, Carfilzomib, Dexamethasoneunclassified | NCT05704049 | ||||
| SAR448501unclassified | NCT06392477 | ||||
| Investigational hMPV/RSV vaccine, Investigational hMPV vaccine …unclassified | NCT06686654 | ||||
| Isatuximab IV, Isatuximab SC, Dexamethasoneunclassified | NCT05405166 | ||||
| PCV21, 20vPCVunclassified | NCT06838000 | ||||
| SAR444836unclassified | NCT05972629 | ||||
| Amlitelimab, Placebounclassified | NCT06033833 | ||||
| Acne mRNA vaccineunclassified | NCT07013747 | ||||
| efanesoctocog alfa (BIVV001)unclassified | NCT04644575 | ||||
| Long term follow up in all patients who received SAR422459 in p…unclassified | NCT01736592 | ||||
| venglustat (GZ402671), imigluceraseunclassified | NCT02843035 | ||||
| Actual Use Trial of Tadalafil 5 mgunclassified | NCT06805513 | ||||
| SAR447971, Placebounclassified | NCT07629336 |
Healthy-volunteer / Phase 1 studies (2) — first-in-human PK/PD & SAD/MAD studies — not indication trials, listed for completeness
| Phase | Mechanism | Company | Modality | Readout | Trial |
|---|---|---|---|---|---|
| VXB-241 60 mcg (Low Dose), VXB-241 120 mcg (Medium Dose), VXB-2… | NCT06556147 | ||||
| Dupilumab coformulated with berahyaluronidase alfa, Dupilumab | NCT07646548 |
Frequently asked
Common questions about the Sanofi pipeline landscape
- What is in Sanofi's drug pipeline?
- Sanofi's clinical pipeline maps to 19 indications and 28 mechanisms of action across 66 classified clinical trials. The heatmap shows each program by indication × mechanism, shaded by the most-advanced phase.
- What indications is Sanofi developing drugs for?
- Sanofi has clinical programs across 19 indications, most actively in Ulcerative Colitis, Immunology — other, and Crohn's Disease.
- What drug mechanisms is Sanofi pursuing?
- Sanofi's pipeline spans 28 mechanisms, including IL-33, BTK inhibitor, IL-4Rα inhibitor, Anti-TNF / OX40L, and Oral TNFR1.
- Does Sanofi have upcoming clinical readouts or FDA decisions?
- Near-term catalysts on Sanofi's tracked programs include SAR441344 IV (data readout, Jul '26); Isatuximab intravenous (data readout, Nov '26); SAR442970 (data readout, Dec '26). Dates are estimated trial primary-completion readouts and confirmed FDA decision dates.
- Where does Sanofi's pipeline 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 Sanofi heatmap free to use?
- Yes — viewing and searching the Sanofi 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 — one disease — companies (rows) × mechanism of action (columns): who is competing, and on what mechanism.
- Company portfolio (this page) — 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].
Respiratory
Sanofi — Active Trials by Therapeutic Area
TheraRadar.com
Full Therapeutic Area Breakdown
15 more therapeutic areas: Immunology, Oncology, Rare Disease, Metabolic, CNS and 10 more.
Active Trials by Phase
Top 10 Indications (active)
Total Trials by TA (lifetime)
Immunology
Oncology
Rare Disease
Metabolic
CNS
Infectious Disease
Dermatology
Urology
Ophthalmology
Cardiovascular
Pain
Musculoskeletal
Gastrointestinal
Renal
Sleep
Click an indication to see the competitive landscape (all sponsors in that indication).
Data: ClinicalTrials.gov · Trials registered 2008 onwards.