Scope & Taxonomy

The LAI universe, defined

A Long-Acting Injectable is a parenteral formulation engineered to extend therapeutic duration from days to months — through a drug delivery system or a half-life extension technology. Vectora defines the covered universe by three cumulative criteria.

What qualifies as a LAI

Every asset meets three cumulative criteria. All three are required.

  • 1Injectable route. Every injectable route is in scope — IM, SC, IV, intra-articular, intravitreal, intratympanic, and others (illustrative, not a restriction). Not oral, not transdermal, not standalone non-injectable implants.
  • 2A deliberate duration technology. Either a Drug Delivery System (the formulation releases the drug over time) or Half-Life Extension (the molecule is engineered to last). A long native half-life alone does not count.
  • 3Duration that breaks with daily dosing. Significantly longer than the indication's immediate-release standard, with a hard floor of ≥ 48 hours after a single dose.

Out of scope

Some molecules are long-acting for reasons that fall outside this definition. They are excluded:

  • ✕Long-acting by mechanism, not technology. Bisphosphonates, botulinum toxin, native-long-half-life antibodies — the effect comes from the biological target, not a delivery or half-life technology.
  • ✕Daily basal insulins. Lantus, Levemir, Tresiba carry real HLE chemistry but act under 48h and are injected daily. Out. Only weekly-plus HLE insulins (e.g. insulin icodec) qualify.
  • ✕Pure implants. A device placed by procedure, not an injectable drug-delivery technology — out of scope.
  • ✕Short or daily injectables. Below the 48-hour floor, whatever the label suggests.
  • ✕Vaccines, cell & gene therapy. Out by editorial scope — unless a DDS/HLE technology carries the payload. The test is the source of the duration: engineered delivery, not the biology itself.

Thresholds by indication

"Long-acting" means something different in post-operative pain than in schizophrenia. The threshold is relative to each indication's standard of care, with the 48-hour floor underneath.

IndicationImmediate-release standardQualifying long-acting assets
Post-op painbupivacaine ~4–6hEXPAREL (48h), ZYNRELEF (72h)
Opioid use disorderdaily buprenorphineSublocade (monthly), Brixadi (weekly–monthly)
HIV / PrEPdaily oralCabenuva (1–2 monthly), Apretude (2-monthly), Sunlenca (6-monthly)
Schizophreniadaily oralInvega Sustenna (monthly), Uzedy (monthly), Hafyera (6-monthly)
Endocrine oncologyleuprolide IRLupron Depot, Eligard, Zoladex
Acromegaly / NEToctreotide ~4hSandostatin LAR, Somatuline (monthly)
Type-2 diabetesexenatide BIDOzempic, Trulicity, Bydureon (weekly)
Hemophiliarecombinant factorALTUVIIIO, Adynovate, Elocta (weekly–bi-weekly)

How the taxonomy is built

Every asset sits on one of two branches, each a set of named families.

Drug Delivery System · DDS

The formulation releases the drug over time. Two facets that co-exist: the physical form the drug takes, and any chemical modification that slows release. A single product can carry both — paliperidone palmitate is a nanocrystal (physical) and an ester prodrug (chemical). Two orthogonal facts, two fields, each queryable on its own.

Half-Life Extension · HLE

The molecule itself is engineered to last longer in circulation — a PEG chain, an Fc domain, a fatty acid, a fused polypeptide, or a direct link to albumin. The duration is built into the drug substance, not into the way it is formulated or injected.

Families are the archetypes named across the LAI field, each mapping to a distinct set of players, IP and manufacturing. Assignment is deterministic: where a product could fit two physical families, a fixed rule decides — a system that forms its depot inside the body takes the in-situ label over the shape it ends up as. ROVI's ISM, for example, is classed in-situ forming depot, not microsphere, even though its particles form in situ.

The technology families, defined

The full vocabulary, one line per family, with a market example. This is the reference behind every technology tag in Vectora.

DDS · Physical release
FamilyWhat it isExample
MicrospherePolymer microparticles encapsulating the drug, injected as a suspension.Risperdal Consta, Sandostatin LAR
NanocrystalNano-sized crystals of the drug itself, no carrier — slow to dissolve.Invega Sustenna, Aristada
NanoparticleCarrier nanoparticles (silica, polymer) that hold the drug.DelSiTech, PharmaShell (platforms)
In-situ forming depotA liquid injected that forms a gel or solid depot in the body.Sublocade, Eligard (Atrigel), Brixadi
Gel depotA pre-formed gel / semi-solid, injected as-is.Somatuline, Acthar Gel
ImplantA pre-formed solid implant, injected or placed via applicator.Zoladex, Ozurdex
LiposomeLipid vesicles carrying the drug.EXPAREL (DepoFoam)
Oil depotThe drug (often an ester) dissolved in an oil vehicle.Nebido, decanoate depots

Matrix material — a secondary tag when a physical family applies: polymer · lipid · hydrogel · inorganic — or none when the drug is its own matrix.

DDS · Chemical release
FamilyWhat it isExample
ProdrugThe drug is chemically modified (most often an ester) so it converts back slowly after injection.Paliperidone palmitate, testosterone esters
Cleavable conjugateThe drug is linked to a carrier by a bond that cleaves slowly to release it.TransCon (Skytrofa)

Physical and chemical co-occur: a product can be both (a nanocrystal that is also an ester prodrug). That is by design — two orthogonal facts, two fields.

HLE · Mechanisms
MechanismWhat it isExample
PEGylationA PEG chain is attached, enlarging the molecule's hydrodynamic size and slowing renal clearance.Peginterferon, pegfilgrastim
Fc fusionThe molecule is fused to an antibody Fc domain, which recycles via the FcRn receptor.Trulicity, ALTUVIIIO
Albumin bindingThe molecule is engineered to attach directly to serum albumin — by genetic fusion or a covalent tether — and borrows its long half-life.Idelvion (fusion), Parsabiv (covalent)
LipidationA fatty-acid or diacid is conjugated to the peptide.Semaglutide, tirzepatide, insulin icodec
Glyco-engineeringExtra glycosylation shields the molecule and slows clearance.Aranesp (darbepoetin alfa)
Protein-fusion extenderA long, unstructured polypeptide is genetically fused to add hydrodynamic bulk.ALTUVIIIO (XTEN), Elonva (CTP)

Platform vs mechanism. A named platform (Atrigel, TransCon, PASylation…) is the branded implementation; the family is the mechanism class it belongs to. That is why "PASylation" sits as a platform under protein-fusion extender, alongside XTEN, ELP and CTP, rather than as its own mechanism.

Frequently asked questions

Why isn't PASylation its own mechanism, like PEGylation?
A mechanism family is a class we query, not a brand. PEGylation, Fc fusion and lipidation are mechanism classes. PASylation is a platform — like XTEN, ELP and CTP — whose mechanism is steric bulk from a fused polypeptide, which we label protein-fusion extender. A mechanism becomes its own family only when it is both autonomous and queried as a class; these platforms share one mechanism and differ by chemistry, so we group the mechanism and name the platform separately.
How do lipidation and albumin binding differ?
Lipidation names a chemistry: a fatty acid conjugated to the peptide. Albumin binding names a different family — molecules engineered to attach directly to albumin, by genetic fusion or a covalent tether (Idelvion, etelcalcetide). A lipidated peptide such as semaglutide is classed by its chemistry, lipidation; that it then binds albumin in circulation is its mechanism, carried by the family, not a second tag — the same way a PEGylated molecule is classed by PEGylation, not by the steric effect PEG produces.
Why are long-acting antibodies excluded, but Fc-fusion proteins included?
The test is the source of the duration. A monoclonal antibody is already long-lived by its nature — an IgG half-life of ~3 weeks, sometimes stretched by generic Fc/FcRn engineering (YTE-type). That is antibody biology, not a delivery technology, so it is out (e.g. Depemokimab, Marstacimab). An Fc-fusion protein bolts an Fc onto a molecule that would otherwise be short-acting — a deliberate, proprietary HLE construct — so it is in (e.g. ALTUVIIIO). An antibody enters the moment it carries a proprietary DDS/HLE technology of its own. What decides is whether the long action was engineered onto the molecule or is native to its class.
Why is ROVI's ISM classed as in-situ forming depot, not microsphere?
A system that forms its depot in the body takes the in-situ label over the shape it ends up as — the tie-break for products that could fit two physical families. ISM is injected as a liquid and its particles precipitate in situ; classing it in-situ keeps that query complete and consistent across the base.
Can one product be in two families at once?
Yes, in two places. Across the two DDS facets — a product can be a physical family and a chemical family at once (a nanocrystal that is also an ester prodrug: paliperidone palmitate). And in HLE, when a molecule stacks two distinct extension technologies — ALTUVIIIO carries both an Fc fusion and an XTEN polypeptide. A lipidated peptide is not such a case: it is classed by its chemistry, lipidation, alone.
And daily basal insulins, or antibodies dosed monthly?
Out. Daily basal insulins (Lantus, Levemir, Tresiba) carry real HLE chemistry but act under 48h and are injected daily — only weekly-plus HLE insulins (e.g. insulin icodec) qualify. A monthly antibody whose duration is native IgG biology is out for the reason above — unless it adds a proprietary LAI technology.

The data model

  • Entities — companies, assets, marketed products (trademarks), technologies, indications.
  • Two grains — each asset is a molecule × delivery technology × developer — sized and segmented by phase, technology, target or modality; each product is a brand × authority — the real regulatory profile, FDA against EMA, label by label.
  • Provenance — sourced to the primary record: products to their FDA / EMA label, assets to ClinicalTrials.gov and company disclosures.
Scope as defined by Vectora · Coverage current to July 2026